HeartMate II controllers recalled over corrosion at the battery connector
Thoratec is recalling 2,424 HeartMate II Pocket Controllers because potential corrosion at the backup battery cable connector may cause a Backup Battery Fault Alarm.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Scored 3 under the risk-of-harm criterion: corrosion affecting the backup battery path on a heart pump controller is a hazard, and no injuries are reported.
Plain-English summary
The HeartMate II Controller (standalone) is being recalled across models 106017, 106762 and 107801, all Pocket Controllers.
The recall follows potential corrosion issues associated with the Backup Battery cable connector that may cause a Backup Battery Fault Alarm.
The recall covers 2,424 units. All units of the listed models are impacted, with model 106017 carrying UDI 00813024011248. Distribution was worldwide, including nationwide in the United States. The FDA has classified the action as Class II.
The controller drives an implanted heart pump, so its backup power path matters. The enforcement record reports no injuries. Patients and clinicians should follow Thoratec's instructions.
The recalled product
- Product
- Brand Name: HeartMate Product Name: HeartMate II¿ Controller (standalone) Model/Catalog Number: 106017, HeartMate II¿ Pocket Controller, US; 106762, HeartMate II¿ Pocket Controller, US; 107801, HeartMate II¿ Pocket Controller Software Version: N/A Product Description: The…
- Manufacturer
- Thoratec LLC
- Affected units
- 2,424
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 (1)
- it can be replaced (per the IFU) and the controller will continue to be used.
Distribution
Part of a larger recall action
This product is one of 4 recalled by Thoratec LLC under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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