Abiomed Recalls Impella RP Flex with SmartAssist Heart Pumps Due to Sensor Malfunction
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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 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, MedicalDevice.
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
Original source: FDA Official Notice ↗
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