Thoratec Corp. recalls

12 recalls on record · latest: May 8, 2024

Official U.S. recall history for Thoratec Corp., compiled from official government records.

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Thoratec Corp. recalls Thoratec HeartMate System Monitor, REF: 1286, L1286, 1286A, L1286A, 1286A-US, L1286A-US, 1286C, L1286C, L1386, 1286A-CA…

May 8, 2024 · Medical device recalls High risk System monitor screen may display atypical behavior: Overlapping screens/button…

Thoratec Corp. recalls Thoratec HeartMate 3, LVAS Implant Kit, REF:106524US, Sterile EO, RxOnly

March 1, 2024 · Medical device recalls High risk Potential for a leak path at the seal interface between the left ventricle assi…

Thoratec Corp. recalls Thoratec HeartMate 3, LVAS Implant Kit, REF:106524INT, Sterile EO, RxOnly

March 1, 2024 · Medical device recalls High risk Potential for a leak path at the seal interface between the left ventricle assi…

Thoratec Corp. recalls HeartMate 3 Left Ventricular Assist System (LVAS): 1. HeartMate 3 Sealed Outflow Graft with Bend Relief, Investigationa…

February 19, 2024 · Medical device recalls High risk Observed outflow graft deformation known as Extrinsic Outflow Graft Obstruction…

Thoratec Corp. recalls HeartMate II Left Ventricular Assist System (LVAS): 1. HeartMate II Sealed Outflow Graft with Bend Relief REF 103393 2.…

February 19, 2024 · Medical device recalls High risk Observed outflow graft deformation known as Extrinsic Outflow Graft Obstruction…

Thoratec Corp. recalls 1. HeartMate Touch Communication System, REF HMT1100 2. HeartMate Touch Communication System, Rental REF HMT1100-R 3. H…

January 3, 2024 · Medical device recalls High risk Due to software and controller systems that results in unexpected pump start or…

Thoratec Corp. recalls Heartmate 3 LVAS Implant Kit, REF: 106524US, 106524INT; Heartmate XVE & HeartMate II Apical Coring Knife, REF: 1050

August 7, 2023 · Medical device recalls Moderate risk Inability to start and/or complete the coring procedure due to inadequate sharp…

Thoratec Corp. recalls Abbott HeartMate Touch Communication System, REF: HMT1100 (US), HMT1100-R (Rental US), HMT1150 (EU)

October 22, 2021 · Medical device recalls Moderate risk If LVAS communication system is trying to establish Bluetooth connection and an…

Thoratec Corp. recalls HeartMate 3 Mobile Power Unit, REF 107754, UDI or GTIN: 00813024010883, and 107758, UDI or GTIN: 00813024010890, when c…

December 2, 2019 · Medical device recalls Moderate risk Excessive static electricity can potentially cause unrecoverable power loss and…

Thoratec Corp. recalls Thoratec Heartmate 3 Sealed Outflow Graft with Bend Relief, Sterile, REF 105581US/105581, RX only, Part of Left Ventric…

March 30, 2019 · Medical device recalls Moderate risk Outflow Graft leaking at the pump connection during the implantation process. I…

Thoratec Corp. recalls Thoratec HeartMate 3 LVAS Implant Kit, Sterile, REF 106524/106524US, RX only, Left Ventricular Assist System

March 30, 2019 · Medical device recalls Moderate risk Outflow Graft leaking at the pump connection during the implantation process. I…

Thoratec Corp. recalls Thoratec HeartMate 3 Coring Tool, Sterile EO, Rx Only, REF 10005872, an optional accessory of Thoratec HeartMate 3 Left…

March 1, 2019 · Medical device recalls Moderate risk Small black plastic particle was observed in the left ventricle during implant…