Heart Pump Correction: Abiomed Updates Use Instructions For Impella Rp With Smartassist Devices
Recall Summary Abiomed is updating instructions for certain Impella RP heart pump devices with SmartAssist technology because the pressure sensor may malfunction and provide inaccurate readings. The affected devices are temporary heart pumps used to support patients with heart failure. This recall applies to users of Impella RP devices equipped with SmartAssist.
- Product
- Impella RP with SmartAssist Devices
- Reason
- The differential pressure sensor in certain Impella devices may malfunction and cause sensor values to drift.
- Category
- medical device recall
- Country
- United States
- Agency
- FDA-MEDWATCH-RSS
- Recall date
- 2026-04-03
- Status
- Ongoing
Official recall notice from FDA-MEDWATCH-RSS
Recall details on Nibble Recalls: https://trynibble.app/recalls/bde6f2c9-8bb1-4bb1-b246-53d46af38ac7