Thoratec LLC recalls Brand Name: HeartMate Product Name: HeartMate 3 Controller (Standalone) Model/Catalog Number: 106531US, HeartMate 3 Controller, US;…
Due to potential corrosion issues associated with the Backup Battery cable connector that may cause a Backup Battery Fault Alarm.
Read the official notice →- Date
- 2025-11-26
- Country
- United States
- Brand
- Thoratec
- Product
- Brand Name: HeartMate Product Name: HeartMate 3 Controller (Standalone) Model/Catalog Number: 106531US, HeartMate 3 Controller, US;…
- Classification
- Class II
- Units
- Worldwide - US Nationwide distribution including in the states of AK, AL, AR,…
- Category
- Drugs & medical
- Source
- FDA · Device
Copied automatically from the US Food and Drug Administration. Details may be shortened or out of date; the official notice is the authoritative source. Disclaimer
What to do
- Check the product name, strength and lot number against the official notice.
- Do not stop a prescribed medicine without talking to your doctor or pharmacist first.
- Ask the pharmacy or supplier about a replacement or refund.
General guidance from Recall Atlas. The official notice from the US Food and Drug Administration has the exact models, batch codes and remedy, and it takes priority.
More Thoratec recalls
- 2026-06-24
USThoratec LLC recalls Brand Name: HeartMate Product Name: HeartMate 3" System Controller Model/Catalog Number: 106531US Software Version: N/A Product…
Due to 11 volt Backup Battery failures.
FDA · DeviceThoratec LLCWorldwide - US Nationwide distribution including in the states of AL, AR, AZ,…Official notice →- 2026-01-21
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Thoratec LLC recalls CentriMag Blood Pump, REF: 102953, 201-20003, 201-90010, 201-90016; CentriMag RVAD HDE KIT, REF: 104318; CentriMag Pre-connected Pack,…
Acute circulatory support system pump may not fit into the motor and reports received of the pump not being securely locked into the motor using the screw-in locking feature. Failure to properly lock the pump into…
FDA · DeviceThoratec LLCWorldwide - US Nationwide distribution including in the states of MN, PA, OK,…Official notice → - 2025-08-20
- US
Thoratec LLC recalls Brand Name: HeartMate Product Name: Mobile Power Unit, AC Power Cord Model/Catalog Number: 107760 Software Version: N/A Product…
Due to misaligned V-Lock feature on the Mobile Power Unit power cords, which prevents the locking mechanism from properly engaging with the Mobile Power Unit and may cause unintended disconnect.
FDA · DeviceThoratec LLCWorldwide - US Nationwide distribution including in the states of AL, AR, AZ,…Official notice → - 2025-04-23
- US
Thoratec LLC recalls HeartMate Mobile Power Unit: REF: 107754, NA; 107758, EU; 107758AU, AU; 107758UK, UK; L107758, EU Rental. Used with HeartMate 3 and II…
Left Ventricular Assist System Mobile Power Unit (MPU) may have electrical component that may cause MPU not to turn on, unprompted shut down, or turning off/restarting, may cause system controller to indicate Yellow…
FDA · DeviceThoratec LLCWorldwide - US Nationwide distribution in the states of WA, NE, VA, PA, DC,…Official notice → - 2024-08-21
- US
Thoratec LLC recalls HeartMate 3 System Controllers provided within the following HeartMate 3 Left Ventricular Assist System (LVAS) Implant Kits or distributed…
Left ventricular assist system controller UI membrane/screen may lift along the edge of the controller housing, and if controller is exposed to fluid, ingress may occur, which may damage printed circuit board…
FDA · DeviceThoratec LLCUS: MN, PA, FL, IL, NY, DE, AR, NJ, NC, GA, WI, AZ, TN, MO, TX, MA, OH, VA,…Official notice → - 2024-06-19
- US
Thoratec Corp. recalls Thoratec HeartMate System Monitor, REF: 1286, L1286, 1286A, L1286A, 1286A-US, L1286A-US, 1286C, L1286C, L1386, 1286A-CAN, 1286INT and…
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…
FDA · DeviceThoratec Corp.Worldwide distribution. US nationwide including Puerto Rico, UNITED ARAB…Official notice →
Other drugs & medical recalls in the United States
- 2025-11-26
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Medline Industries, LP recalls MEDLINE convenience kits labeled as: 1) ACH PLASTICS BREAST-LF, REF CDS983639K; 2) BREAST ABD, REF CDS984267J; 3) PLASTIC PACK, REF…
Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits containing SafeAir Smoke Evacuation Pencils. Stryker Instruments has expanded the scope of their recall of SafeAir Smoke…
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Medline Industries, LP recalls MEDLINE STERILE BASIC EYE PACK 16: 1) REF: DYNJ37743D; 2) REF: DYNJ37743F.
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Medtronic Perfusion Systems recalls MC3 VitalFlow Console, REF 58100; Blood pump of ecmo
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ELEKTA SOLUTIONS AB recalls MOSAIQ Oncology Information System Software Builds 3.1.3, 3.2.1, 3.2.2 & 3.2.3.0 Software Version and UDI Codes: 3.1.3.0…
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TMJ Solutions Inc recalls TMJ Bilateral Implant REF: CHG020 Sterile EO, Rx Only
Patient-fitted temporomandibular joint implant contained discrepancy in screw hole position.
FDA · DeviceTMJ Solutions IncUS: IL, OR, MS, TX, OK, UT, MA, MD, NY, PA, VA, FL, CA, MN, GA OUS: Canada,…Official notice →