Edwards Lifesciences, LLC recalls PASCAL Precision Transcatheter Valve Repair System, Models: 20000ISM and 20000IS
Due to a manufacturing issue, when using valve repair systems, intended to repair insufficient mitral and/or tricuspid valves, users experienced resistance when attempting to release the implant from the delivery…
Read the official notice →- Date
- 2023-09-06
- Country
- United States
- Brand
- Edwards Lifesciences
- Product
- PASCAL Precision Transcatheter Valve Repair System, Models: 20000ISM and 20000IS
- Classification
- Class II
- Units
- International distribution to the countries of Austria, Belgium, Switzerland,…
- 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 Details may be shortened or out of date; the official notice is the authoritative source.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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