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.
Read the official notice →- Date
- 2024-05-08
- Country
- United States
- Brand
- Thoratec
- Product
- Thoratec HeartMate 3, LVAS Implant Kit, REF:106524US, Sterile EO, RxOnly
- Classification
- Class I
- Units
- Worldwide Distribution: US (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 Details may be shortened or out of date; the official notice is the authoritative source.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.
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