Thoratec HeartMate 3, LVAS Implant Kit, REF:106524US, Sterile EO, RxOnly
Reported: May 8, 2024 Initiated: March 1, 2024 #Z-1692-2024
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.
Details
- Recalling Firm
- Thoratec Corp.
- Units Affected
- 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, Canada, Cayman Islands, Chile, Colombia, Czech Republic, Denmark, Egypt, Estonia, Finland, France, Germany, Greece, Hong Kong, India, Iran, Iraq, Ireland, Israel, Italy, Japan, Kuwait, Lebanon, Lithuania, Macedonia, Malaysia, Martinique, Mexico, Morocco, Netherlands, New Zealand, Norway, Oman, Philippines, Poland, Portugal, Qatar, Romania, Russia, Saudi Arabia, Serbia, Singapore, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, UK, United Arab Emirates, and Uzbekistan.
- Location
- Pleasanton, CA
Frequently Asked Questions
What product was recalled? ▼
Thoratec HeartMate 3, LVAS Implant Kit, REF:106524US, Sterile EO, RxOnly. Recalled by Thoratec Corp.. Units affected: 882 units.
Why was this product recalled? ▼
Potential for a leak path at the seal interface between the left ventricle assist system inflow cannula and the titanium apical cuff.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on May 8, 2024. Severity: Critical. Recall number: Z-1692-2024.
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