Class II U.S. Food and Drug Administration

Thoratec LLC Brand Name: HeartMate Product Name: HeartMate II¿ Controller Model/ recall: Due to potential corrosion issues associated with the Backup Battery cable

Recall published 11 months ago

Due to potential corrosion issues associated with the Backup Battery cable connector that may cause a Backup Battery Fault Alarm.

The hazard: Device safety concern

A device recall was filed for this product. For anything implanted or relied on daily, the clinician comes before the paperwork.

What the notice says: Due to potential corrosion issues associated with the Backup Battery cable connector that may cause a Backup Battery Fault Alarm.

Why it matters: The FDA recorded an enforcement action against this device. Most device recalls are corrections rather than removals, so the device often stays in use while the manufacturer issues a fix.

Recall details

Recall number
Z-0508-2026
Published
November 26, 2025
Risk level
Class II
Status
Ongoing
Issued by
U.S. Food and Drug Administration
Brand
Thoratec LLC
Product type
Medical devices
Units affected
2424
Distribution
Nationwide
Made in
United States
Lot / code info
Lot Code: All units of the following models are impacted: Model 106017 UDI: 00813024011248 Model 106762 UDI: 00813024011286 Model 107801 UDI: 00813024011996 Note: Product bracketing is determined based on possible use of the controller. Since the backup battery has a 3 year life cycle, it can be replaced (per the IFU) and the controller will continue to be used.
UPC codes
00813024011248, 00813024011286, 00813024011996

Products covered by this recall

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 HeartMate II System Controller is a small computer that controls and monitors system operation. It sends power and operating signals to the Left Ventricular Assist Device and adjusts device operation to maintain programmed levels of cardiac support. The System Controller identifies alarm conditions and initiates Hazard and Advisory alarms. It records device performance and alarm data, and transfers the information to the HeartMate Touch Communication System. Component: Yes, HeartMate II¿ LVAS Implant Kit

Check your product

The notice names 8 codes you can read straight off the package. Type the one printed on yours and the list below narrows to it.

UPC / barcode

Read the twelve digits under the barcode on the package.

  • 00813024011248
  • 00813024011286
  • 00813024011996

Model or item number

On the rating label, the box or the instruction sheet.

  • 106017
  • HeartMate II
  • 106017 UDI
  • 106762 UDI
  • 107801 UDI

Codes are lifted verbatim from the FDA — Device enforcement notice. A code that is missing here may still be covered — the official notice is the complete list.

What to do about Device

Thoratec LLC — A device recall was filed for this product. For anything implanted or relied on daily, the clinician comes before the paperwork.

  1. Match the model, catalogue, lot and serial numbers on your device against the identifiers on this page.
  2. If you are a facility, quarantine affected stock and log the correction.
  3. Report device problems to the FDA through MedWatch.
  4. If the device is implanted or you depend on it daily, speak to your clinician before changing how you use it.

Claiming on a recalled device

Device recalls are tracked by serial and lot number, so your claim moves faster if you lead with those.

  • Have the model, catalogue, lot and serial numbers ready before you call — they are on the device label or its box.
  • Ask explicitly whether your unit is in the affected range; many recalls cover only part of a model line.
  • If you need the device daily, ask what interim arrangement they offer while the remedy is carried out.
  • Log the date, the name and the reference number of every call. Device recalls can run for months.

Company contact: Thoratec LLC — 6035 Stoneridge Dr, Pleasanton, CA, 94588-3270

The official notice

This page summarises a notice published by U.S. Food and Drug Administration. The agency notice is the authoritative version — read it before you act, and treat it as the final word if anything here looks different.

Open the FDA — Device enforcement record U.S. Food and Drug Administration recalls

Questions people ask about this recall

Why was Thoratec LLC medical devices recalled?

Due to potential corrosion issues associated with the Backup Battery cable connector that may cause a Backup Battery Fault Alarm. Due to potential corrosion issues associated with the Backup Battery cable connector that may cause a Backup Battery Fault Alarm.

How do I know if I have the recalled product?

Match the codes printed on your package against the notice: UPC 00813024011248, 00813024011286, 00813024011996; model number 106017, HeartMate II, 106017 UDI. If the code on your package is not on that list, your unit is outside the recall.

What should I do with it right now?

Match the model, catalogue, lot and serial numbers on your device against the identifiers on this page.

Can I get my money back?

Have the model, catalogue, lot and serial numbers ready before you call — they are on the device label or its box.

Where was the recalled product sold?

It was distributed nationwide.

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