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.
Read the official notice →- Date
- 2024-03-27
- Country
- United States
- Brand
- Thoratec
- Product
- HeartMate 3 Left Ventricular Assist System (LVAS): 1. HeartMate 3 Sealed Outflow Graft with Bend Relief, Investigational Device Exemption…
- Classification
- Class I
- Units
- Worldwide distribution: U.S.(nationwide): AL,AR, AZ, CA, CO, CT, DC, DE, FL,…
- 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 Details may be shortened or out of date; the official notice is the authoritative source.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
- 2024-08-21
USThoratec 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 → - 2024-05-08
- US
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 → - 2024-02-14
- US
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.
FDA · DeviceThoratec Corp.Worldwide distribution. US nationwide, Australia, Austria, Canada, Colombia,…Official notice → - 2023-10-11
- US
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 → - 2021-12-08
- US
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 →
Other drugs & medical recalls in the United States
- 2024-03-27
- US
Natus Neurology Inc recalls TENSIVE Conductive Adhesive Gel, REF 016-401600
Natus has become aware that its third-party supplier Parker Laboratories Inc. is conducting a voluntary recall related to their Tensive Conductive Adhesive Gel, Ref. 22-60 Lot Number A0623009. They have received five…
FDA · DeviceNatus Neurology IncWorldwide distribution - US Nationwide and the country of Canada.Official notice → - US
Siemens Healthcare Diagnostics, Inc. recalls DCA Systems HbA1c Reagent Kit
The reason for the recall is that the Siemens DCA HbA1c Reagent Kit was confirmed to display a positive bias without alerting the user. The potential impact of the defect is that erroneous test results could be…
FDA · DeviceSiemens Healthcare Diagnostics, Inc.Worldwide distribution - US Nationwide and the country of Taiwan.Official notice → - US
Beckman Coulter, Inc. recalls Access Total T4, REF 33800, IVD, thyroxine reagent assay.
Four lots of Access Total T4 reagent lots demonstrated imprecision outside of the 10% specification which may result in erroneous or delayed results.
FDA · DeviceBeckman Coulter, Inc.Worldwide distribution - US Nationwide, including Puerto Rico and the…Official notice → - US
Smiths Medical ASD Inc. recalls smiths medical Pneupac paraPAC plus 310 ventilator kit with PEEP and CPAP, REF P310NUS
When a paraPAC plus ventilator is switched to the operating mode of VENTILATE, the ventilator may intermittently provide continuous positive gas flow instead of the intended cycling like a human breath. This…
FDA · DeviceSmiths Medical ASD Inc.Worldwide distribution: US (nationwide) and OUS countries of: Algeria,…Official notice → - US
ARROW INTERNATIONAL Inc. recalls ARROW QuickFlash Radial Artery Catherization (wire, guide, catheter), Part Numbers: a) REF AK-04220; b) REF ASK-04220-FMH1; c) REF…
Teleflex is initiating this voluntary recall for the above-mentioned products due to reports received indicating a potentially defective component. The complaints received relate to resistance of the guidewire…
FDA · DeviceARROW INTERNATIONAL Inc.Worldwide distribution: US (nationwide) and OUS (foreign) to countries of: AE,…Official notice → - US
Super Chill Products recalls Neptune's Fix, Tianeptine Elixir, Fast Acting, 0.338 fl.oz. (10 mL) bottle, Distributed By Superchill Products, 827 6th Avenue, New York,…
Marketed without an approved NDA/ANDA: Product contains tianeptine, a substance not FDA-approved for any medical use in the United States.