Recall Z-1692-2024— Thoratec Corp.
Class I · Ongoing
Class I FDA medical device recall by Thoratec Corp., initiated 2024-03-01. FDA's recall record names no specific 510(k) clearance for this event. Product: Thoratec HeartMate 3, LVAS Implant Kit, REF:106524US, Sterile EO, RxOnly. Reason: Potential for a leak path at the seal interface between the left ventricle assist system inflow cannula and the titanium apical cuff..
- Recalling firm
- Thoratec Corp.
- Classification
- Class I
- Status
- Ongoing
- Initiated
- 2024-03-01
- Firm location
- Pleasanton, CA, United States
Product description
Thoratec HeartMate 3, LVAS Implant Kit, REF:106524US, Sterile EO, RxOnly
Reason for recall
Potential for a leak path at the seal interface between the left ventricle assist system inflow cannula and the titanium apical cuff.
Data sourced from openFDA. This site is unofficial and independent of the FDA.