FDA recall record · openFDA

Thoratec Corp.

7 FDA recalls on record (2023–2024) — 7 device. 7 still ongoing.

Class I (most serious)

Class II

Class III

ongoing

How to read this. A recall count is not a quality verdict — large manufacturers recall more simply by volume, and a voluntary recall is the safety system working as intended. The signal to weight is the Class I count (the FDA's most-serious tier — reasonable probability of serious harm or death) and whether recalls are still ongoing. Most recalls are Class II/III. "Ongoing" reflects openFDA's last-published status — device recalls often stay marked ongoing long after they're resolved in practice; confirm current status at the FDA.

Most common reasons

Potential for a leak path at the seal interface between the left ventricle assist system inflow cannula and the titanium 2

Observed outflow graft deformation known as Extrinsic Outflow Graft Obstruction (EOGO) associated with Left Ventricular 2

Due to software and controller systems that results in unexpected pump start or pump stop. 1

Inability to start and/or complete the coring procedure due to inadequate sharpness of the Apical Coring Knife, provided 1

System monitor screen may display atypical behavior: Overlapping screens/buttons, Frozen screen, Distorted text, blanks, 1

Recalls

Thoratec HeartMate 3, LVAS Implant Kit, REF:106524US, Sterile EO, RxOnly Class I 2024-03-01 HeartMate 3 Left Ventricular Assist System (LVAS): 1. HeartMate 3 Sealed Outflow Graft with Bend Relief, Investigationa Class I 2024-02-19 HeartMate II Left Ventricular Assist System (LVAS): 1. HeartMate II Sealed Outflow Graft with Bend Relief REF 103393 2 Class I 2024-02-19 1. HeartMate Touch Communication System, REF HMT1100 2. HeartMate Touch Communication System, Rental REF HMT1100-R 3. Class I 2024-01-03 Thoratec HeartMate 3, LVAS Implant Kit, REF:106524INT, Sterile EO, RxOnly Class I 2024-03-01 Thoratec HeartMate System Monitor, REF: 1286, L1286, 1286A, L1286A, 1286A-US, L1286A-US, 1286C, L1286C, L1386, 1286A-CAN Class I 2024-05-08 Heartmate 3 LVAS Implant Kit, REF: 106524US, 106524INT; Heartmate XVE & HeartMate II Apical Coring Knife, REF: 1050 Class II 2023-08-07

RECORDED — these are the FDA's published recall enforcement records (openFDA). Recalls are listed under the exact firm name as filed; a large manufacturer may also file under name variants, so this may not be the company's complete cross-variant record — confirm at the FDA recall database. This page informs and routes; it is not medical advice or a verdict on the company.

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