Abiomed, Inc. Issues Recall for Impella RP with SmartAssist Over Sensor Malfunction
Abiomed, Inc. is recalling 291 units of the Impella RP with SmartAssist heart pump due to a differential pressure sensor defect that may cause inaccurate readings.
What Happened
Abiomed, Inc. has initiated a voluntary recall of the Impella RP with SmartAssist system. The recall follows reports that the differential pressure (dP) sensor within the devices may malfunction, leading to a drift in sensor values. This issue was identified as a firm-initiated action starting in January 2026.
Which Products Are Affected
The recall involves 291 units distributed worldwide. Specific identification details include:
- Product Name: Impella RP with SmartAssist
- Product Code: 0046-0035
- UDI-DI: 00813502011869
- Recall Number: Z-1469-2026
- Geographic Scope: US Nationwide and international distribution including Austria, Canada, Croatia, Czechia, France, Germany, Hong Kong, Italy, Poland, Serbia, and Switzerland.
What You Should Do
The recall was initiated by Abiomed, Inc. through a formal notification letter sent to affected customers. Healthcare professionals and facilities currently utilizing these devices should review the instructions provided in the firm’s notification regarding the potential for sensor drift. For further information, stakeholders may contact Abiomed, Inc. at their headquarters in Danvers, MA.
Why This Matters
This recall has been designated as Class I by the FDA, the most serious classification. The sensor malfunction poses a significant risk to patient safety, as inaccurate pressure data could impact critical clinical decision-making during the use of the heart pump.
Source
Information provided by the FDA.
Source: FDA Official Notice