Abbott HeartMate 3 LVAS Implant Kit Recalled for Graft Occlusion Risk
Abbott is recalling HeartMate 3 LVAS Implant Kits due to reports of outflow graft twist occlusions that can cause serious adverse events.
What this means for you
Highest-severity recall. Risk of serious injury or death is documented or strongly suspected. Stop using the product now and follow the agency's instructions.
Our severity reasoning: The source text explicitly states that outflow graft occlusions can result in death, which meets the rubric criterion for a score of 5 (Critical) due to known fatalities or potential for death.
Plain-English summary
Abbott is recalling the Thoratec HeartMate 3 LVAS Implant Kit (Catalog # 106524US, 106524, 10652INT) because of reports of outflow graft twist occlusions. This medical device is indicated for providing short-term hemodynamic support in patients with advanced refractory left ventricular heart failure.
The recall is being conducted because outflow graft occlusions can result in serious adverse events, including hemodynamic compromise, thrombus, and death. Patients whose devices experience these occlusions will experience a persistent low flow alarm.
The affected units were distributed worldwide, including in the United States and numerous international countries. The source text does not specify the number of affected units or the number of reported injuries or deaths. Consumers and healthcare providers should contact Abbott or their healthcare provider for instructions on how to proceed.
The recalled product
- 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.
- Manufacturer
- Abbott
- Category
- Medical Device — Cardiovascular
- Affected units
- 5,607
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- United States: UDI: 00813024013297
- Serial Numbers: MLP 000976
- MLP 000989
- MLP 000991
- MLP 000999
- MLP 001002
- MLP 002020
- MLP 002041
- MLP 002048
- MLP 002049
- MLP 002056
- MLP 002057
- MLP 002058
- MLP 002059
- MLP 002066
- MLP 002069
- MLP 002070
- MLP 002071
- MLP 002072
- MLP 002074
Distribution
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