Abiomed Impella CP Set with SmartAssist Recall
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 168 units of Impella CP Sets with SmartAssist due to potential thrombus formation during prolonged use of the introducer.
What this FDA recall tells you, and what most readers miss
This notice was issued by FDA on August 5, 2026 and geographically references United States. 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, medical-devices.
What Happened
Abiomed, Inc. initiated a voluntary recall of certain Impella CP Sets with SmartAssist containing affected 14Fr Low Profile Introducer Kits due to the potential for thrombus formation during prolonged use of the introducer. The recall is classified as Class I by the FDA and affects units distributed in specific U.S. states and Japan.
Which Products Are Affected
The affected products are Abiomed Impella CP Set with SmartAssist (10th Generation). Product Codes: 1000413 (GTIN: 00813502013566) and 1000834 (GTIN: 00813502013948). A total of 168 units are involved, with specific serial numbers and batch numbers for introducers (Product Codes 2000684 and 2000785) listed in the recall. Distribution includes the states of FL, IL, MN, NJ, NY, VA and Japan. Recall number: Z-2601-2026.
What You Should Do
Consumers and healthcare providers should follow instructions provided in the firm's notification letter regarding the affected devices.
Why This Matters
This Class I recall involves a device used in cardiac support where thrombus formation could pose serious health risks during extended use.
Source
FDA recall Z-2601-2026, Abiomed, Inc., Danvers, MA. https://www.fda.gov
Original source: FDA Official Notice ↗
Related FDA Recalls
All FDA Recalls →Nationwide notices with similar length or severity timing 8
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 (1,209 characters here).
Similar severity timing
Same severity (high) notices issued closest in time to August 5, 2026.
Frequently Asked Questions
Common questions about this FDA recall.