Abiomed Recalls Impella RP Heart Pumps Over Sensor Malfunction Risks
Areazine synthesizes this FDA recall directly from FDA's official public data feed. See our methodology for full source attribution and refresh cadence.
Abiomed, Inc. is recalling 179 Impella RP devices due to a differential pressure sensor defect that can cause inaccurate data readings.
What this FDA recall tells you, and what most readers miss
This notice was issued by FDA on April 2, 2026 and geographically references Worldwide. Its severity classification of "high" signals how the issuing agency weighs the risk of harm if no action is taken - "critical" and "high" tier alerts typically carry direct consumer actions, while "medium" and "low" tend toward informational guidance or monitoring advisories. The category it belongs to - FDA Recalls - determines the consumer-protection framework behind it, which shapes what remedies (refunds, replacements, repairs, or the recall itself) are available to affected consumers and which agency holds statutory responsibility for enforcement.
Most readers skim a notice like this, check whether they are personally affected, and move on. The more useful lens is to verify its scope, source, and timestamp, then compare related notices without assuming that one record proves a broader trend.
Areazine pairs this record with the original agency URL so you can check the primary source before acting. Its related labels are recall, product-safety, fda, MedicalDevices.
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).
Original source: FDA Official Notice ↗
Related FDA Recalls
All FDA Recalls →Frequently Asked Questions
Common questions about this FDA recall.