The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-0507-2026·Announced 2025-11-26

Heart pump implant kits recalled over corrosion at the battery connector

Thoratec is recalling 248 HeartMate II LVAS Implant Kits 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 system is a hazard, and no injuries are reported.

Plain-English summary

The HeartMate II LVAS Implant Kit with Pocket Controller, sealed, is being recalled across models 106015 (US) and 106016 (EU).

The recall follows potential corrosion issues associated with the Backup Battery cable connector that may cause a Backup Battery Fault Alarm.

The recall covers 248 units. All units of the listed models are impacted, with model 106015 carrying UDI 00813024011224. Distribution was worldwide, including nationwide in the United States. The FDA has classified the action as Class II.

The kit supports 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¿ LVAS Implant Kit Model/Catalog Number: 106015, HeartMate II¿ LVAS Kit, with Pocket Controller, Sealed, US; 106016, HeartMate II¿ LVAS Kit, with Pocket Controller, Sealed, EU Software Version: N/A Product Description: The…
Manufacturer
Thoratec LLC
Category
Medical Device — Ventricular assist device
Hazard
Affected units
248

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

Distributed nationwide across the United States.

The notice also names 42 states specifically:

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.

See all 4 products in this recall →

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