Maquet Medical Systems USA recalls

38 recalls on record · latest: April 15, 2024

Official U.S. recall history for Maquet Medical Systems USA, compiled from official government records.

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Maquet Medical Systems USA recalls CARDIOHELP-i System. Blood oxygenation and carbon dioxide removal system.

April 15, 2024 · Medical device recalls Moderate risk The firm identified that the measured patient leakage current in some devices s…

Maquet Medical Systems USA recalls BEQ-HLS 7050 USA, HLS Set Advanced 7.0, Product Code/Part Number 70106.9078. Used with the CARDIOHELP heart-lung machin…

January 16, 2024 · Medical device recalls Moderate risk The Emergency Priming Line, a component of the HLS Set, may have a compromised…

Maquet Medical Systems USA recalls Model No. BEQ-HLS 5050 USA, HLS Set Advanced 5.0, Product Code/Part Number 70106.9077. Used with the CARDIOHELP heart-l…

January 16, 2024 · Medical device recalls Moderate risk The Emergency Priming Line, a component of the HLS Set, may have a compromised…

Maquet Medical Systems USA recalls BO-RF-32-USA RotaFlow Centrifugal Pump with SOFTLINE Coating, Product Code 701047553. For use with an extracorporeal ca…

January 8, 2024 · Medical device recalls Moderate risk Nonconformities at their seal could potentially compromise the sterile barrier…

Maquet Medical Systems USA recalls BEQ-RF-32-USA RotaFlow Centrifugal Pump with BIOLINE Coating, Product Code 701047554. For use with an extracorporeal ca…

January 8, 2024 · Medical device recalls Moderate risk Nonconformities at their seal could potentially compromise the sterile barrier…

Maquet Medical Systems USA recalls Bubble Sensor (REF: 70105.5720)

December 28, 2023 · Medical device recalls Moderate risk The Bubble Sensor optional accessory to the CARDIOHELP-i extracorporeal life su…

Maquet Medical Systems USA recalls CARDIOHELP-i Heart Lung Support System: Blood oxygenation and carbon dioxide removal system used to pump blood through…

November 14, 2023 · Medical device recalls CARDIOHELP-i System was not properly tested to measure leakage current

Maquet Medical Systems USA recalls Venous probe connection cable (REF 701069333 and 701048804) used with the Cardiohelp-i System, part numbers 701072780 a…

November 13, 2023 · Medical device recalls Moderate risk Firm received complaints of breaks in the insulation, shielding, or wires of th…

Maquet Medical Systems USA recalls CARDIOHELP-i Heart Lung Support System- A blood oxygenation and carbon dioxide removal system used to pump blood throug…

November 6, 2023 · Medical device recalls Moderate risk Certain factory settings for the device were incorrectly described in the IFU-r…

Maquet Medical Systems USA recalls Cardiohelp-i, blood oxygenation and carbon dioxide removal system, Part Numbers 701072780 (Cardiohelp-i), 701068550 (Sl…

October 12, 2023 · Medical device recalls Moderate risk It was found that the fixation (weld) employed by the supplier of the nut bolt…

Maquet Medical Systems USA recalls CARDIOHELP Emergency Drive, Part Numbers 701048002 and 701076205. The CARDIOHELP System is a blood oxygenation and carb…

October 10, 2023 · Medical device recalls High risk Product removal due to possible blocking or impairment of the CARDIOHELP Emerge…

QUADROX -i Neonatal recalled over sterility concerns

May 18, 2023 · Medical device recalls Moderate risk Product packaging may exhibit small pinholes which may not be visible to the un…

QUADROX-i Small Adult recalled over sterility concerns

May 18, 2023 · Medical device recalls Moderate risk Product packaging may exhibit small pinholes which may not be visible to the un…

QUADROX-i Pediatric recalled over sterility concerns

May 18, 2023 · Medical device recalls Moderate risk 1. An accessory may be improperly placed during packaging, causing creases and…

BEQ-HMO USA/ QUADROX-i Small recalled over sterility concerns

May 18, 2023 · Medical device recalls Moderate risk 1. An accessory may be improperly placed during packaging, causing creases and…

QUADROX -i Neonatal recalled over sterility concerns

May 18, 2023 · Medical device recalls Moderate risk 1. An accessory may be improperly placed during packaging, causing creases and…

QUADROX-i Adult recalled over sterility concerns

May 18, 2023 · Medical device recalls Moderate risk Product packaging may exhibit small pinholes which may not be visible to the un…

QUADROX-iD Adult recalled over sterility concerns

May 18, 2023 · Medical device recalls Moderate risk Product packaging may exhibit small pinholes which may not be visible to the un…

QUADROX-iD Pediatric recalled over sterility concerns

May 18, 2023 · Medical device recalls Moderate risk Product packaging may exhibit small pinholes which may not be visible to the un…

BEQ-HMOD70000-USA/QUADROX-iD recalled over sterility concerns

May 18, 2023 · Medical device recalls Moderate risk 1. An accessory may be improperly placed during packaging, causing creases and…

QUADROX-iR recalled over sterility concerns

May 18, 2023 · Medical device recalls Moderate risk 1. An accessory may be improperly placed during packaging, causing creases and…

QUADROX-i Adult recalled over sterility concerns

May 18, 2023 · Medical device recalls Moderate risk 1. An accessory may be improperly placed during packaging, causing creases and…

QUADROX-i Pediatric recalled over sterility concerns

May 18, 2023 · Medical device recalls Moderate risk Product packaging may exhibit small pinholes which may not be visible to the un…

QUADROX-i Small Adult recalled over sterility concerns

May 18, 2023 · Medical device recalls Moderate risk 1. An accessory may be improperly placed during packaging, causing creases and…

Venous Hardshell Cardiotomy Reservoir recalled over sterility concerns

May 18, 2023 · Medical device recalls Moderate risk 1. An accessory may be improperly placed during packaging, causing creases and…

Venous Hardshell Cardiotomy Reservoir recalled over sterility concerns

May 18, 2023 · Medical device recalls Moderate risk Product packaging may exhibit small pinholes which may not be visible to the un…

QUADROX-iR recalled over sterility concerns

May 18, 2023 · Medical device recalls Moderate risk Product packaging may exhibit small pinholes which may not be visible to the un…

BEQ-HMO USA /QUADROX-i Adult recalled over sterility concerns

May 18, 2023 · Medical device recalls Moderate risk 1. An accessory may be improperly placed during packaging, causing creases and…

HMOD USA/QUADROX-iD Adult recalled over sterility concerns

May 18, 2023 · Medical device recalls Moderate risk 1. An accessory may be improperly placed during packaging, causing creases and…

Maquet Medical Systems product recalled over sterility concerns

February 13, 2023 · Medical device recalls Moderate risk Firm has initiated a removal of the product due to insufficient evidence of pac…

Maquet Medical Systems USA recalls BEQ-HLS 5050 USA; HLS Set Advanced 5.0 Part No. 70105.2797. A preconnected set used for extracorporeal respiratory and/…

July 22, 2022 · Medical device recalls Moderate risk The firm has expanded the recall for the HLS Set Advanced regarding a potential…

Maquet Medical Systems USA recalls BEQ-HLS 7050 USA; HLS Set Advanced 7.0 Part No. 70105.2794. A preconnected set used for extracorporeal respiratory and/…

July 22, 2022 · Medical device recalls Moderate risk The firm has expanded the recall for the HLS Set Advanced regarding a potential…

Maquet Medical Systems USA recalls BEQ-HLS 7050 USA; HLS Set Advanced 7.0 Part No. 70106.9078. A preconnected set used for extracorporeal respiratory and/…

July 22, 2022 · Medical device recalls Moderate risk The firm has expanded the recall for the HLS Set Advanced regarding a potential…

Maquet Medical Systems USA recalls BEQ-HLS 5050 USA; HLS Set Advanced 5.0 Part No. 70106.9077. A preconnected set used for extracorporeal respiratory and/…

July 22, 2022 · Medical device recalls Moderate risk The firm has expanded the recall for the HLS Set Advanced regarding a potential…

Maquet Medical Systems USA recalls Cardiohelp-i Transport Guard with Transport Guard (701072525): is a blood oxygenation and carbon dioxide removal system…

February 18, 2022 · Medical device recalls Moderate risk Potential for a loose cylindrical pin on the Transport Guard that may result in…

Maquet Medical Systems USA recalls Heater Cooler Unit (HCU 30) The device supplies temperature-controlled water for cardioplegia heat exchangers and for b…

July 14, 2021 · Medical device recalls Moderate risk There is the potential for contaminated water to enter parts of the Heater-Cool…

Maquet Medical Systems USA recalls Accessory Adapter Part number 600525A0 Product Usage: designed for the mounting of MAQUET accessories with the dovetail…

October 5, 2016 · Medical device recalls Moderate risk Maquet Inc. is initiating a voluntary field action on the Accessory Adapter par…

Maquet Medical Systems USA recalls TEGRIS System manufactured by MAQUET GMBH in Germany The Maquet Tegris OR Integration System is designed to be used as…

August 21, 2014 · Medical device recalls Moderate risk The wrong movement results on the MAGNUS OR table. The button commands on the T…