Abiomed, Inc. Issues Recall for Impella RP with SmartAssist Over Sensor Malfunction
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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 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 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.
Original source: FDA Official Notice ↗
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