Recall Z-1774-2018— Abbott
Class I · Terminated
Class I FDA medical device recall by Abbott, initiated 2018-04-05, terminated 2021-10-15. FDA's recall record names no specific 510(k) clearance for this event. Product: Thoratec HeartMate 3 LVAS Implant Kit, Rx Only, Catalog # 106524US, 106524, 10652INT - LVAS KIT, HM 3 Indicated for providing short-term hemodynamic support in patients with advanced refractory left ventricular heart failure.. Reason: Reports of outflow graft twist occlusions. Patients whose devices experience outflow graft occlusions will experience a persistent low flow alarm. Outflow graft occlusions can result in serious adverse events such as hemodynamic compromise, thrombus, and death..
- Recalling firm
- Abbott
- Classification
- Class I
- Status
- Terminated
- Initiated
- 2018-04-05
- Terminated
- 2021-10-15
- Firm location
- Pleasanton, CA, United States
Product description
Thoratec HeartMate 3 LVAS Implant Kit, Rx Only, Catalog # 106524US, 106524, 10652INT - LVAS KIT, HM 3 Indicated for providing short-term hemodynamic support in patients with advanced refractory left ventricular heart failure.
Reason for recall
Reports of outflow graft twist occlusions. Patients whose devices experience outflow graft occlusions will experience a persistent low flow alarm. Outflow graft occlusions can result in serious adverse events such as hemodynamic compromise, thrombus, and death.
Data sourced from openFDA. This site is unofficial and independent of the FDA.