Recall Z-1692-2024 ยท DSQ Ventricular (Assist) Bypass
Thoratec Corp.
Thoratec HeartMate 3, LVAS Implant Kit, REF:106524US, Sterile EO, RxOnly
| Date | May 1, 2024 (initiated Mar 1, 2024) |
| Status | Open, Classified |
| Reason | Potential for a leak path at the seal interface between the left ventricle assist system inflow cannula and the titanium apical cuff. |
| Root cause | Device Design |
| Action | On March 20, 2024, Abbott issued a Urgent: Medical Device Correction Notification to affected consignee via E-Mail. Abbott asked consignees to take the following actions: 1. The product is not being removed from the field and unused product does not need to be returned. 2. If blood leak or air entrainment is suspected or observed, follow standard surgical processes and the existing IFU: 2a. Residual air must be completely evacuated from the device blood chamber prior to initiating the LVAD support. 2b.Ensure that bleeding is assessed and ensure proper management of hemostasis before closin |
| Quantity | 882 units |
| Distribution | Worldwide Distribution: US (nationwide): AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, NE, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, & WV; and OUS (foreign) countries of: Australia, Austria, Bangladesh, Belgium, Brazil, Bulgaria, Ca |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.