medical HIGH RISK Updated 2024-06-19

Thoratec Corp. recalls Thoratec HeartMate System Monitor, REF: 1286, L1286, 1286A,

See all recalls from Thoratec Corp. →

Recalled Product

Thoratec HeartMate System Monitor, REF: 1286, L1286, 1286A, L1286A, 1286A-US, L1286A-US, 1286C, L1286C, L1386, 1286A-CAN, 1286INT and L1286INT. Left ventricular assist device

Share this recall: Facebook X / Twitter WhatsApp Email

Hazard / Issue

System monitor screen may display atypical behavior: Overlapping screens/buttons, Frozen screen, Distorted text, blanks, or zeroes in place of values, Unresponsive buttons where the user is unable to initiate a command, which may lead to anxiety /inconvenience, hemodynamic compromise, extended surgical time, and Pump Stop command may be selected

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: UDI-DI: 00813024010142, 00813024010852. All Serial Numbers

✅ What Should You Do?

  1. 1Contact your healthcare provider immediately to discuss this recall.
  2. 2Stop using the device if it is safe to do so, and contact your provider.
  3. 3Follow the manufacturer's remedy instructions provided in the recall notice.
  4. 4Report device problems to FDA MedWatch or call 1-800-FDA-1088.

Looking for a safe alternative?

Search Amazon for Thoratec HeartMate System Monitor, →

If you were harmed by this recalled product, Top Class Actions lists active class action lawsuits and settlements that may apply to you.

View official government recall

Related medical Recalls

Medline Industries, LP recalls Medline convenience kits: PORT A CATH DYNJ906818A

2026-06-24 · Kits contain recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive. Butyrate tubing may crack during actuation and render product unusable for application.

Medline Industries, LP recalls Medline convenience kits: LOOP PACK DYNJ61460C OPEN H

2026-06-24 · Kits contain recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive. Butyrate tubing may crack during actuation and render product unusable for application.

Beta Bionics, Inc. recalls iLet Bionic Pancreas, REF: BB1001

2026-06-24 · The reason for the recall is: it was found in version 3.3.6 of the iLet ACE Pump firmware and all previous releases that a screen unlock failure could occur when the user successfully slides the unlock slider on the Lock Screen, no screen transition occurs, and the user remains on the Lock Screen. Because the user cannot exit the Lock Screen, the user is unable to perform a cartridge change or meal announcement. If this occurs and therapy is in progress, therapy will continue normally until the insulin cartridge is depleted. The user will be unable to perform a cartridge change or a meal announcement and will be stuck on the screen until the battery fully drains. This can lead to hyperglycemia.

Medline Industries, LP recalls Medline convenience kits: 20CM CVC INSERTION KIT ECVC680

2026-06-24 · Kits contain recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive. Butyrate tubing may crack during actuation and render product unusable for application.