Heartware, Inc. recalls

68 recalls on record · latest: October 31, 2023

Official U.S. recall history for Heartware, Inc., compiled from official government records.

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Heartware, Inc. recalls PUMP 1103 HVAD (HeartWare Ventricular Assist Device) IMPLANT KIT, Model Number 1103

October 31, 2023 · Medical device recalls Moderate risk Updates to the HVAD system instructions for use (IFU) and patient manual (PM) w…

Heartware, Inc. recalls HVAD (HeartWare Ventricular Assist Device) STERILE IMPLANT KIT/IMPLANT KIT OUS, Model Number 1205

October 31, 2023 · Medical device recalls Moderate risk Updates to the HVAD system instructions for use (IFU) and patient manual (PM) w…

Heartware, Inc. recalls PUMP 1104 HVAD (HeartWare Ventricular Assist Device) IMPLANT KIT EN JA, Model Number 1104JP

October 31, 2023 · Medical device recalls Moderate risk Updates to the HVAD system instructions for use (IFU) and patient manual (PM) w…

Heartware, Inc. recalls HVAD (HeartWare Ventricular Assist Device) STERILE IMPLANT KIT, Model Number 1100

October 31, 2023 · Medical device recalls Moderate risk Updates to the HVAD system instructions for use (IFU) and patient manual (PM) w…

Heartware, Inc. recalls PUMP 1104 HVAD (HeartWare Ventricular Assist Device) IMPLANT KIT, Model Number 1104

October 31, 2023 · Medical device recalls Moderate risk Updates to the HVAD system instructions for use (IFU) and patient manual (PM) w…

Heartware, Inc. recalls PUMP MCS1705PU HVAD (HeartWare Ventricular Assist Device) IMPLANT KIT US, Model Number MCS1705PU

October 31, 2023 · Medical device recalls Moderate risk Updates to the HVAD system instructions for use (IFU) and patient manual (PM) w…

Heartware, Inc. recalls STERILE HVAD (HeartWare Ventricular Assist Device) PUMP (US), Model Number 1101

October 31, 2023 · Medical device recalls Moderate risk Updates to the HVAD system instructions for use (IFU) and patient manual (PM) w…

Heartware, Inc. recalls HVAD (HeartWare Ventricular Assist Device) STERILE IMPLANT KIT, Model Number 1102

October 31, 2023 · Medical device recalls Moderate risk Updates to the HVAD system instructions for use (IFU) and patient manual (PM) w…

Heartware, Inc. recalls 1104CA-CLIN - HVAD (HeartWare Ventricular Assist Device) PUMP, Model Number 1104CA-CLIN

October 31, 2023 · Medical device recalls Moderate risk Updates to the HVAD system instructions for use (IFU) and patient manual (PM) w…

Heartware, Inc. recalls HeartWare Ventricular Assist Device System. a) Monitor 1521US Explore Tech, b) Monitor 1521GB Explore Tech, c) Monitor…

May 16, 2023 · Medical device recalls Moderate risk Medtronic has identified that the logfiles downloaded from the recently updated…

Heartware, Inc. recalls HeartWare Model 1100

November 29, 2022 · Medical device recalls Moderate risk Over time, the driveline cover may become hardened, creating difficulty or an i…

Heartware, Inc. recalls HeartWare HVAD Pump Kit, REF 1104CA-CLIN

November 29, 2022 · Medical device recalls Moderate risk Over time, the driveline cover may become hardened, creating difficulty or an i…

Heartware, Inc. recalls HeartWare Model 1101

November 29, 2022 · Medical device recalls Moderate risk Over time, the driveline cover may become hardened, creating difficulty or an i…

Heartware, Inc. recalls HeartWare HVAD Pump Kit, REF 1103

November 29, 2022 · Medical device recalls Moderate risk Over time, the driveline cover may become hardened, creating difficulty or an i…

Heartware, Inc. recalls HeartWare HVAD Pump Kit, REF 1104

November 29, 2022 · Medical device recalls Moderate risk Over time, the driveline cover may become hardened, creating difficulty or an i…

Heartware, Inc. recalls HeartWare HVAD Pump Kit, REF MCS1705PU

November 29, 2022 · Medical device recalls Moderate risk Over time, the driveline cover may become hardened, creating difficulty or an i…

Heartware, Inc. recalls HeartWare Model 1102

November 29, 2022 · Medical device recalls Moderate risk Over time, the driveline cover may become hardened, creating difficulty or an i…

Heartware, Inc. recalls HeartWare HVAD Pump Kit, REF 1205

November 29, 2022 · Medical device recalls Moderate risk Over time, the driveline cover may become hardened, creating difficulty or an i…

Heartware, Inc. recalls HeartWare HVAD Pump Kit, REF 1104JP

November 29, 2022 · Medical device recalls Moderate risk Over time, the driveline cover may become hardened, creating difficulty or an i…

Heartware, Inc. recalls HeartWare Ventricular Assist Device (HVAD) System Batteries, Product Number 1650DE

June 28, 2022 · Medical device recalls High risk Battery performance issues. Battery electrical faults render it unable to power…

Heartware, Inc. recalls HeartWare Ventricular Assist Device (HVAD) System Controller, Model Number 1407DE Kit

March 30, 2022 · Medical device recalls Moderate risk Finnish and Turkish translation errors in HVAD controller and monitor displays…

Heartware, Inc. recalls HeartWare Ventricular Assist Device (HVAD) System, Model Number 1521DE, MONITOR 1521DE EXPLORE TECH

March 30, 2022 · Medical device recalls Moderate risk Finnish and Turkish translation errors in HVAD controller and monitor displays…

Heartware, Inc. recalls HeartWare Ventricular Assist Device (HVAD) System Controller, Model Number 1420

March 30, 2022 · Medical device recalls Moderate risk Finnish and Turkish translation errors in HVAD controller and monitor displays…

Heartware, Inc. recalls HeartWare Ventricular Assist Device (HVAD) System Controller, Model Number 1420-Controller 2.0

March 30, 2022 · Medical device recalls Moderate risk Finnish and Turkish translation errors in HVAD controller and monitor displays…

Heartware, Inc. recalls HeartWare Ventricular Assist Device (HVAD) System, individual pamphlets: HVAD¿ System Emergency Responder Guide (FI-Fin…

March 30, 2022 · Medical device recalls Moderate risk Finnish and Turkish translation errors in HVAD controller and monitor displays…

Heartware, Inc. recalls HeartWare Ventricular Assist Device (HVAD) System, Pump Implant Kit, Model Number1104

March 30, 2022 · Medical device recalls Moderate risk Finnish and Turkish translation errors in HVAD controller and monitor displays…

Heartware, Inc. recalls HeartWare Ventricular Assist Device (HVAD) System

January 27, 2022 · Medical device recalls Moderate risk Updated cleaning instructions are being provided for the Controller AC Adapter,…

Heartware, Inc. recalls Medtronic HVAD Pump Implant Kits

August 6, 2021 · Medical device recalls Moderate risk There is more force required to slide the driveline cover (boot cover) away fro…

Heartware, Inc. recalls HeartWare HVAD Pump Implant Kit, REF 1125

June 3, 2021 · Medical device recalls High risk Medtronic is stopping the distribution and sale of the HVAD System due to a gro…

Heartware, Inc. recalls HeartWare HVAD Pump Implant Kit, REF 1153

June 3, 2021 · Medical device recalls High risk Medtronic is stopping the distribution and sale of the HVAD System due to a gro…

Heartware, Inc. recalls HeartWare HVAD Outflow Graft, REF MCS1725OG

June 3, 2021 · Medical device recalls High risk Medtronic is stopping the distribution and sale of the HVAD System due to a gro…

Heartware, Inc. recalls HeartWare HVAD Pump Accessories, REF MCS1753AK

June 3, 2021 · Medical device recalls High risk Medtronic is stopping the distribution and sale of the HVAD System due to a gro…

Heartware, Inc. recalls HeartWare HVAD Driveline Extension Cable, REF 100

June 3, 2021 · Medical device recalls High risk Medtronic is stopping the distribution and sale of the HVAD System due to a gro…

Heartware, Inc. recalls HeartWare HVAD Pump Implant Kit, REF 1103

June 3, 2021 · Medical device recalls High risk Medtronic is stopping the distribution and sale of the HVAD System due to a gro…

Heartware, Inc. recalls HeartWare HVAD Pump Implant Kit, REF 1104

June 3, 2021 · Medical device recalls High risk Medtronic is stopping the distribution and sale of the HVAD System due to a gro…

Heartware, Inc. recalls HeartWare HVAD Implant Kit, REF 1104JP

June 3, 2021 · Medical device recalls High risk Medtronic is stopping the distribution and sale of the HVAD System due to a gro…

Heartware, Inc. recalls HeartWare HVAD Driveline Extension Cable, REF 100US

June 3, 2021 · Medical device recalls High risk Medtronic is stopping the distribution and sale of the HVAD System due to a gro…

Heartware, Inc. recalls HeartWare HVAD Implant Kit, REF MCS1705PU

June 3, 2021 · Medical device recalls High risk Medtronic is stopping the distribution and sale of the HVAD System due to a gro…

Heartware, Inc. recalls HeartWare, HVAD Pump Implant Kit, REF MCS1705PU - Product Usage: indicated for hemodynamic support in patients with adv…

May 28, 2021 · Medical device recalls Moderate risk The pump has an impeller with a shroud height that did not meet the lower contr…

Heartware, Inc. recalls Medtronic HVAD Controller, Product Numbers: 1400, 1401, 1401AU, 1401BR, 1401CA, 1401CH, 1401DE, 1401GB, 1401IL, 1401IN,…

February 26, 2021 · Medical device recalls High risk There is the potential for the Controller power cables (AC Adapter, DC Adapter,…

Heartware, Inc. recalls Medtronic HVAD Battery, Product Number: 1650, 1650CA-CLIN, 1650DE

February 26, 2021 · Medical device recalls High risk There is the potential for the Controller power cables (AC Adapter, DC Adapter,…

Heartware, Inc. recalls Medtronic HVAD Monitor Data Cable, Product Number: 1575

February 26, 2021 · Medical device recalls High risk There is the potential for the Controller power cables (AC Adapter, DC Adapter,…

Heartware, Inc. recalls Power Supply: 1. Medtronic HVAD Controller AC Adapter, Product Numbers: 1425AU, 1425CA, 1425DE, 1425GB, 1425IL, 1425IT,…

February 26, 2021 · Medical device recalls High risk There is the potential for the Controller power cables (AC Adapter, DC Adapter,…

Heartware, Inc. recalls Medtronic HVAD Alarm Adapter, Product Number: 1450

February 26, 2021 · Medical device recalls High risk There is the potential for the Controller power cables (AC Adapter, DC Adapter,…

Heartware, Inc. recalls Medtronic HVAD Packaged Monitor, Model Numbers: 1500, 1500AU, 1500DE, 1510US, 1511AR, 1511AU, 1511BR, 1511CA, 1511CH, 1…

February 26, 2021 · Medical device recalls High risk There is the potential for the Controller power cables (AC Adapter, DC Adapter,…

Heartware, Inc. recalls Instructions for Use and Patient Manual for HeartWare HVAD System. Accompanies these devices: Heartware HVAD pump impla…

February 26, 2021 · Medical device recalls Moderate risk IFU and Patient Manual updated to describe HVAD Controller Connection Verificat…

Heartware, Inc. recalls Instructions for Use and Patient Manual for HeartWare HVAD System. Accompanies these devices: Heartware HVAD pump impla…

February 26, 2021 · Medical device recalls Moderate risk IFU and Patient Manual updated to describe Expected Alarm Duration. The Instruc…

Heartware, Inc. recalls Instructions for Use and Patient Manual for HeartWare HVAD System. Accompanies these system components: HVAD Sterile Im…

February 26, 2021 · Medical device recalls High risk Medtronic HeartWare HVAD System Instructions for Use (IFU) and Patient Manual (…

Heartware, Inc. recalls Medtronic HVAD Pump Implant Kits, labeled as: a. PUMP 1103, b. PUMP 1104, c. PUMP 1104JP, d. PUMP 1100, e. Model 1101,…

November 19, 2020 · Medical device recalls High risk Pumps manufactured with impellers from a subset of lots from a single supplier…

Heartware, Inc. recalls Heartware HVAD Pump Implant Kit, Product (REF) Number 1103

April 3, 2020 · Medical device recalls High risk The Outflow Graft may be subject to tears and the Strain Relief screw may break…

Heartware, Inc. recalls Heartware HVAD Pump Outflow Graft, Product (REF) Number 1125

April 3, 2020 · Medical device recalls High risk The Outflow Graft may be subject to tears and the Strain Relief screw may break…

Heartware, Inc. recalls Heartware HVAD Pump Implant Kit, Product (REF) Number 1104

April 3, 2020 · Medical device recalls High risk The Outflow Graft may be subject to tears and the Strain Relief screw may break…

Heartware, Inc. recalls Heartware HVAD Pump Implant Kit, Product (REF) Number 1104JP

April 3, 2020 · Medical device recalls High risk The Outflow Graft may be subject to tears and the Strain Relief screw may break…

Heartware, Inc. recalls Heartware HVAD Pump Implant accessories, Product (REF) Number 1153

April 3, 2020 · Medical device recalls High risk The Outflow Graft may be subject to tears and the Strain Relief screw may break…

Heartware, Inc. recalls HeartWare HVAD System Battery Charger The HeartWare HVAD System is indicated for hemodynamic support in patients with a…

January 23, 2020 · Medical device recalls High risk Potential for an HVAD System user to mistakenly insert the Battery Charger AC A…

Heartware, Inc. recalls HeartWare HVAD System Battery Charger AC Adapter The HeartWare HVAD System is indicated for hemodynamic support in pati…

January 23, 2020 · Medical device recalls High risk Potential for an HVAD System user to mistakenly insert the Battery Charger AC A…

Heartware, Inc. recalls Medtronic HeartWare Ventricular Assist HVAD System Battery Charger Model 1600US - Product Usage: The HeartWare Ventricu…

November 19, 2018 · Medical device recalls Moderate risk HVAD Battery Charger units manufactured with wrong inductors.

Heartware, Inc. recalls Heart Ware(TM) HVAD(TM) System Controller/Controller Kits, Model Numbers: 1403, 1407, and 1420 Product Usage: The Heart…

August 28, 2018 · Medical device recalls Moderate risk Certain HVAD System Controller units may not meet the labeled standard for prot…

HeartWare Ventricular Assist System recalled over foreign material

August 17, 2016 · Medical device recalls High risk Foreign material found within the driveline connector of the HVAD Pump that cou…

Heartware, Inc. recalls HeartWare Ventricular Assist System Controller Product Usage: For use as a bridge-to-cardiac transplantation in patient…

June 8, 2016 · Medical device recalls High risk Loose connector ports in controller body.

Heartware, Inc. recalls HeartWare Ventricular Assist System: HeartWare Battery, Lithium Ion, 14.8 V, Rx only. Catalog 1650 (US) and 1650, 1650-…

January 7, 2016 · Medical device recalls High risk Heartware Ventricular Assist System Battery Cell experiencing premature depleti…

HeartWare Inc recalls HeartWare Ventricular Assist System (HVAD) Pump Driveline Splice Kit Product Usage: Is intended to repair the driveline…

April 29, 2015 · Medical device recalls High risk Failures of the splice repair kit if exposed to excessive force.

HeartWare Inc recalls HeartWare Ventricular Assist System (HVAD) For use as a bridge-to-cardiac transplantation in patient who are at risk of…

April 29, 2015 · Medical device recalls Moderate risk Complaints with the HVAD Discolored and Cracked Driveline Outer Sheath.

HeartWare Inc recalls HeartWare Ventricular Assist System (HVAD). Catalog #: 1101, 1103, 1100, 1101, 1102, 1104, 1104JP, and 1205. Intended f…

April 29, 2015 · Medical device recalls High risk Complaints with the HVAD Retraction of Pins within the driveline connector.

HeartWare Inc recalls HeartWare Ventricular Assist System (HVAD). Catalog #'s US: 1101 and 1103 / OUS: 1100, 1101,1102,1104,1104JP and 1205.…

April 29, 2015 · Medical device recalls High risk HeartWare has received complaints relating to damage or bent connection pins wi…

HeartWare Inc recalls HeartWare Ventricular Assist System (HVAD). Catalog #'s US: 1101 and 1103 / OUS: 1100,1101,1102,1104,1104JP and 1205. F…

April 29, 2015 · Medical device recalls High risk Complaints with the HVAD Internal Controller Alarm Battery failures.

HeartWare Inc recalls HeartWare Ventricular Assist System (HVAD) For use as a bridge-to-cardiac transplantation in patient who are at risk of…

April 29, 2015 · Medical device recalls Moderate risk Complaints with the HVAD Abnormal Power Source Switching.

HeartWare Inc recalls HeartWare Ventricular Assist System (HeartWare Controller) Product Usage: For use as a bridge-to-cardiac transplantatio…

January 16, 2015 · Medical device recalls High risk The affected clinical trial Controllers exhibit a higher susceptibility to ESD…