Abiomed, Inc. recalls Impella RP Flex with SmartAssist intracardiac microaxial blood pump, Product Number 1000323
A higher than expected rate of thrombus formation or deposition has been observed. The risk is for thrombus formations or deposits on indwelling central venous lines or cannulas may break free and enter into the…
Read the official notice →- Date
- 2023-08-09
- Country
- United States
- Brand
- Abiomed
- Product
- Impella RP Flex with SmartAssist intracardiac microaxial blood pump, Product Number 1000323
- Classification
- Class I
- Units
- US Nationwide distribution including in the states of AR, CA, FL, GA, LA, MA,…
- 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 Details may be shortened or out of date; the official notice is the authoritative source.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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