Abiomed Impella Controller Recall for Alarm Delay Issue
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Abiomed, Inc. is recalling 62 units of various Impella Controllers due to a potential delay in the 'Purge System Blocked' alarm, affecting international distribution.
What this FDA recall tells you, and what most readers miss
This notice was issued by FDA on April 15, 2026 and geographically references International. 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, Devices.
What Happened
Abiomed, Inc. is recalling certain Automated Impella Controllers because of a potential delay in the 'Purge System Blocked' alarm display when used with first generation Impella 5.5 pumps. This is a Class I recall, initiated voluntarily by the firm on February 16, 2026.
Which Products Are Affected
The affected products are various Impella Controllers with the following product codes and serial numbers:
- Product Code: 0042-0000-CA; GTIN: 00813502011272; Serial Numbers: IC2035, IC9416.
- Product Code: 0042-0000-EU; GTIN: 00813502011289; Serial Numbers: IC1677, IC3049, IC3099, IC3102, IC4358, IC4329, IC5774, IC5757, IC6580, IC6581.
- Product Code: 0042-0000-UK; GTIN: 00813502011296; Serial Numbers: IC2023, IC1910, IC2704, IC3325, IC3312.
- Product Code: 0042-0000-US; GTIN: 00813502010022; Serial Numbers: IC1140.
- Product Code: 0042-0010-EU; GTIN: 00813502010961; Serial Numbers: IC5403, IC5404, IC5635, IC5636, IC5666, IC5667, IC5801, IC5904, IC5918, IC5921, IC6421, IC6422, IC8683.
- Product Code: 0042-0010-UK; GTIN: 00813502010978; Serial Numbers: IC8101, IC8102, IC8103, IC8104, IC8544, IC9446, IC9449, IC11440.
- Product Code: 0042-0040-CA; GTIN: 00813502012958; Serial Numbers: IC10306, IC10312, IC12604, IC12891, IC12895, IC12892, IC12605, IC12894.
- Product Code: 0042-0040-EU; GTIN: 00813502012217; Serial Numbers: IC9014, IC9022, IC9429, IC10408, IC10425.
- Product Code: 0042-0040-AU; GTIN: 00813502012972; Serial Numbers: IC10163, IC10387, IC11546, IC11566, IC11490, IC11544, IC12008, IC12054, IC11472, IC12151.
All affected units have software versions 8.2.2 through 8.5, with a total quantity of 62 units distributed internationally in Australia, Canada, France, Germany, and Kuwait. The recall number is Z-1591-2026.
What You Should Do
Consumers who have the affected products should follow the firm's initial notification, which was sent via e-mail, for further instructions on the recall. Contact Abiomed, Inc. at their address: 22 Cherry Hill Dr, Danvers, MA 01923-2575, United States, for any questions regarding this recall.
Why This Matters
This recall involves medical devices that could pose a serious risk if the alarm delay occurs, potentially leading to adverse health consequences. It highlights the importance of timely notifications in medical equipment to ensure patient safety.
Source
This information is from the U.S. Food and Drug Administration (FDA). For more details, visit the FDA website at https://www.fda.gov/medical-devices/medical-device-recalls and search for recall number Z-1591-2026.
Original source: FDA Official Notice ↗
Related FDA Recalls
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Two Areazine-derived peer sets for this FDA recall: nearest notices by body length and by same severity near the same agency date. Peers come from other categories so they are not the same-feed Related list above.
Similar body length
Nearest notices by article body length (2,682 characters here).
Similar severity timing
Same severity (high) notices issued closest in time to April 15, 2026.
Frequently Asked Questions
Common questions about this FDA recall.