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Thoratec Corp. FDA Recalls
8 recalls on file across devices, 6 of them Class I and 8 still open. This firm is not matched to a listed company.
Newest first
Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.
| Product |
|---|
| Thoratec HeartMate System Monitor, REF: 1286, L1286, 1286A, L1286A, 1286A-US, L1286A-US, 1286C, L1286C, L1386, 1286A-CANClass IMay 8, 2024System monitor screen may display atypical behavior: Overlap |
| Thoratec HeartMate 3, LVAS Implant Kit, REF:106524INT, Sterile EO, RxOnlyClass IMar 1, 2024Potential for a leak path at the seal interface between the |
| Thoratec HeartMate 3, LVAS Implant Kit, REF:106524US, Sterile EO, RxOnlyClass IMar 1, 2024Potential for a leak path at the seal interface between the |
| HeartMate 3 Left Ventricular Assist System (LVAS): 1. HeartMate 3 Sealed Outflow Graft with Bend Relief, InvestigationaClass IFeb 19, 2024Observed outflow graft deformation known as Extrinsic Outflo |
| HeartMate II Left Ventricular Assist System (LVAS): 1. HeartMate II Sealed Outflow Graft with Bend Relief REF 103393 2Class IFeb 19, 2024Observed outflow graft deformation known as Extrinsic Outflo |
| 1. HeartMate Touch Communication System, REF HMT1100 2. HeartMate Touch Communication System, Rental REF HMT1100-R 3. Class IJan 3, 2024Due to software and controller systems that results in unexp |
| Heartmate 3 LVAS Implant Kit, REF: 106524US, 106524INT; Heartmate XVE & HeartMate II Apical Coring Knife, REF: 1050Class IIAug 7, 2023Inability to start and/or complete the coring procedure due |
| Abbott HeartMate Touch Communication System, REF: HMT1100 (US), HMT1100-R (Rental US), HMT1150 (EU)Class IIOct 22, 2021If LVAS communication system is trying to establish Bluetoot |