Drugs & medicalClass I

Thoratec Corp. recalls 1. HeartMate Touch Communication System, REF HMT1100 2. HeartMate Touch Communication System, Rental REF HMT1100-R 3. HeartMate Touch…

Due to software and controller systems that results in unexpected pump start or pump stop.

Read the official notice →
Date
2024-02-14
Country
United States
Brand
Thoratec
Product
1. HeartMate Touch Communication System, REF HMT1100 2. HeartMate Touch Communication System, Rental REF HMT1100-R 3. HeartMate Touch…
Classification
Class I
Units
Worldwide distribution. US nationwide, Australia, Austria, Canada, Colombia,…
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 Details may be shortened or out of date; the official notice is the authoritative source.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

  1. Check the product name, strength and lot number against the official notice.
  2. Do not stop a prescribed medicine without talking to your doctor or pharmacist first.
  3. 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

  1. 2024-08-21
  2. US
    Drugs & medicalClass II

    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 →
  3. 2024-06-19
  4. US
    Drugs & medicalClass I

    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 →
  5. 2024-05-08
  6. US
    Drugs & medicalClass I

    Thoratec Corp. recalls Thoratec HeartMate 3, LVAS Implant Kit, REF:106524US, Sterile EO, RxOnly

    Potential for a leak path at the seal interface between the left ventricle assist system inflow cannula and the titanium apical cuff.

    FDA · DeviceThoratec Corp.Worldwide Distribution: US (nationwide): AL, AR, AZ, CA, CO, CT, DC, DE, FL,…Official notice →
  7. 2024-03-27
  8. US
    Drugs & medicalClass I

    Thoratec Corp. recalls HeartMate 3 Left Ventricular Assist System (LVAS): 1. HeartMate 3 Sealed Outflow Graft with Bend Relief, Investigational Device Exemption…

    Observed outflow graft deformation known as Extrinsic Outflow Graft Obstruction (EOGO) associated with Left Ventricular Assist System.

    FDA · DeviceThoratec Corp.Worldwide distribution: U.S.(nationwide): AL,AR, AZ, CA, CO, CT, DC, DE, FL,…Official notice →
  9. 2023-10-11
  10. US
    Drugs & medicalClass II

    Thoratec Corp. recalls Heartmate 3 LVAS Implant Kit, REF: 106524US, 106524INT; Heartmate XVE & HeartMate II Apical Coring Knife, REF: 1050

    Inability to start and/or complete the coring procedure due to inadequate sharpness of the Apical Coring Knife, provided with Left Ventricular Assist System, could result in an extended procedure or surgical time while…

    FDA · DeviceThoratec Corp.Worldwide - US Nationwide distribution including in the states of AL, AR, AZ,…Official notice →
  11. 2021-12-08
  12. US
    Drugs & medicalClass II

    Thoratec Corp. recalls Abbott HeartMate Touch Communication System, REF: HMT1100 (US), HMT1100-R (Rental US), HMT1150 (EU)

    If LVAS communication system is trying to establish Bluetooth connection and another Bluetooth-enabled device is nearby and advertising for Bluetooth connection, the Bluetooth connectivity interference may cause the…

    FDA · DeviceThoratec Corp.Worldwide distribution - US Nationwide distribution in the states of FL, IL,…Official notice →
All 12 Thoratec recalls →

Other drugs & medical recalls in the United States

  1. 2024-02-14
  2. US
    Drugs & medicalClass II

    GE Medical Systems, SCS recalls Senographe Pristina

    X-ray exposure termination audible signal on Senographe Pristina with Efficiency Suite 2 intermittently not emitted per 21CFR 1020.31(j) requirements.

    FDA · DeviceGE Medical Systems, SCSUs Nationwide-Worldwide DistributionOfficial notice →
  3. US
    Drugs & medicalClass I

    Cardinal Health 200, LLC recalls Cardinal Health Monoject, 1 mL Purple Enteral Syringe with Enfit Connection Sterile, REF 401SE

    Cardinal Health is expanding their previous product correction actions to a product removal of all sizes of Cardinal Health brand Monoject sterile Syringe Luer-Lock (1, 3, 6, 12, 20, 35, and 60 mL) and Cardinal Health…

    FDA · DeviceCardinal Health 200, LLCDistribution US nationwide and Canada. Foreign distribution updated 9/6/2024…Official notice →
  4. US
    Drugs & medicalClass I

    Cardinal Health 200, LLC recalls Cardinal Health Monoject, 35mL Enteral Syringe (purple) - For Use with ENFit Connection System, REF 435SE

    The listed lots of Cardinal Health Monoject Enteral Syringes with ENFit (6, 12, 35, 60 mL) have recognition and compatibility issues with certain syringe enteral feeding pumps. As a result, Cardinal Health recommends…

    FDA · DeviceCardinal Health 200, LLCDistribution US nationwide and Canada. Foreign distribution updated 9/6/2024…Official notice →
  5. US
    Drugs & medicalClass III

    Amerisource Health Services LLC recalls HydrALAZINE Hydrochloride Tablets, USP, 10 mg, 100-count (10 x 10) per unit dose carton, Rx Only, Distributed by: American Health…

    Failed Impurities/Degradation Specifications: Out of Specification (OOS) result in the repackaged product for Related Compounds (Impurities) at the 6-month time point.

    FDA · DrugAmerisource Health Services LLCNationwide in the USAOfficial notice →
  6. US
    Drugs & medicalClass II

    Amneal Pharmaceuticals of New York, LLC recalls Phenoxybenzamine Hydrochloride Capsules, USP 10mg, 100-count bottle, Rx only, Manufactured by: Amneal Pharmaceuticals…

    Failed Impurities/Degradation Specifications: Out of specification for unknown impurity.

    FDA · DrugAmneal Pharmaceuticals of New York, LLCUSA nationwide.Official notice →
  7. US
    Drugs & medicalClass II

    NATCO Pharma Limited recalls Lansoprazole Delayed-Release Capsules USP, 15 mg, 14-count bottle, Manufactured by: Natco Pharma Limited Kothur- 509 228, India,…

    CGMP Deviations: Inadequate induction sealing on bottles, capsules were observed with bubbles on band seal, capsules with holes and spheres sticking to capsules. Also coding details were missing on one bottle.

    FDA · DrugNATCO Pharma LimitedNationwide in the USAOfficial notice →
See all drugs & medical recalls →