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…
Read the official notice →- Date
- 2024-06-19
- Country
- United States
- Brand
- Thoratec
- Product
- Thoratec HeartMate System Monitor, REF: 1286, L1286, 1286A, L1286A, 1286A-US, L1286A-US, 1286C, L1286C, L1386, 1286A-CAN, 1286INT and…
- Classification
- Class I
- Units
- Worldwide distribution. US nationwide including Puerto Rico, UNITED ARAB…
- 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 Details may be shortened or out of date; the official notice is the authoritative source.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
- 2025-08-20
USThoratec 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 → - 2024-05-08
- 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 → - 2024-03-27
- US
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 → - 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 →
Other drugs & medical recalls in the United States
- 2024-06-19
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Covidien, LLC recalls EsoFLIP, 30mm BALLOON DILATION CATHETER, REF ES-330, Rx Only
Due to saline conductivity issues, their is a potential that dilation catheters may provide inaccurate esophageal diameter measurements that may lead to various harms.
FDA · DeviceCovidien, LLCWorldwide - US Nationwide distribution including in the states of AK, AL, AZ,…Official notice → - US
Avanos Medical, Inc. recalls NEOMED* Pharmacy Syringes - Nonsterile (Non ENFit) with below product descriptions: a.0.5mL Oral Syringe Orange NonSterile, Product Code…
The expiration date was not printed on the outer shipping label, leading to expired syringes being shipped to customers.
FDA · DeviceAvanos Medical, Inc.Worldwide distribution - US Nationwide and the countries of Australia, New…Official notice → - US
Wondfo USA Co Ltd recalls Preview Strep A, Streptococcal A rapid test kits, Part Numbers: a) PRE-STA-25, b) PRE-STA-A-10
Wondfo USA has identified unauthorized distribution of the Preview Strep A Test Kit. Unauthorized distribution of this device would include sales and distribution of this test for at-home use, non-prescription use,…
- US
Sagent Pharmaceuticals recalls Docetaxel Injection, USP, 160 mg per 16 mL (10 mg per mL), 1 x 16 mL Multi-Dose Vial, Rx only, Mfd. for Sagent Pharmaceuticals,…
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RemedyRepack Inc. recalls Phenazopyridine HCl, 100mg tablets, 6 count bottles, Rx Only, Repackaged by: RemedyRepack, Inc., Indiana, PA NDC#: 70518-0218-00, Source…
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