Agency classClass IOur severity:Critical FDA (Devices)·Z-1774-2018·Announced 2018-05-23

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.

The agency’s classification

FDA (Devices): Class I

Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 5/5 (Critical).

Highest-severity recall. The hazard can cause serious injury or death. 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
Hazard: hemodynamic-compromise
thrombus
death
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

Distributed in 35 states:

Same manufacturer · Abbott

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