Abiomed Recalls Impella RP Heart Pumps Over Sensor Malfunction Risks
Abiomed, Inc. is recalling 179 Impella RP devices due to a differential pressure sensor defect that can cause inaccurate data readings.
What Happened
Abiomed, Inc. has issued a voluntary recall for its Impella RP devices following reports of a malfunction in the differential pressure (dP) sensor. According to the FDA, the sensor may fail, causing the pressure values to drift and potentially providing inaccurate data during clinical use.
Which Products Are Affected
The recall involves 179 units of the Impella RP device distributed worldwide.
- Product Name: Impella RP
- Product Code: 0046-0011
- UDI-DI: 04260113630273
- Recall Number: Z-1471-2026
- Distribution: United States (Nationwide) and international locations including Austria, Canada, Croatia, Czechia, France, Germany, Hong Kong, Italy, Poland, Serbia, and Switzerland.
What You Should Do
Abiomed initiated the recall process on January 27, 2026, by sending notification letters to affected customers. Healthcare facilities and providers should review their inventory for the specified product code and follow the guidance provided in the firm’s notification letter. For further inquiries, customers should contact Abiomed, Inc. at their Danvers, MA headquarters.
Why This Matters
The FDA has classified this as a Class I recall, which is the most serious category. A malfunctioning sensor in a cardiac device like the Impella RP can lead to incorrect clinical decisions or device failure, posing a significant risk to patient safety.
Source
Information provided by the U.S. Food and Drug Administration (FDA).
Source: FDA Official Notice