Abiomed Recalls Impella RP Flex with SmartAssist Heart Pumps Due to Sensor Malfunction
Abiomed, Inc. has issued a Class I recall for 4,496 Impella RP Flex with SmartAssist devices due to sensor drift issues that could impact patient monitoring.
What Happened
Abiomed, Inc. has initiated a voluntary recall of the Impella RP Flex with SmartAssist medical device. The recall was triggered by reports that the differential pressure (dP) sensor in these devices may malfunction. This defect can cause sensor values to drift, potentially providing inaccurate data during use.
Which Products Are Affected
The recall affects 4,496 units distributed worldwide. Specific identification details include:
- Product Name: Impella RP Flex with SmartAssist
- Product Code: 1000323
- UDI-DI: 00813502012811
- Recall Number: Z-1470-2026
- Distribution Scope: Worldwide, including the United States (nationwide) and international distribution to Austria, Canada, Croatia, Czechia, France, Germany, Hong Kong, Italy, Poland, Serbia, and Switzerland.
What You Should Do
Affected customers were initially notified via a firm-issued letter on January 27, 2026. Healthcare facilities and providers currently using these devices should follow the specific guidance provided in Abiomed’s notification letter. For additional information or inquiries regarding the recall, contact Abiomed, Inc. at their headquarters in Danvers, Massachusetts.
Why This Matters
The FDA has categorized this as a Class I recall, which is the most serious classification. A malfunctioning sensor in a heart pump device can lead to incorrect clinical decisions or patient harm if the device’s performance is not accurately monitored.
Source
Source: FDA Official Notice