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 7 units of the Impella CP Set 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 6, 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, Devices.
What Happened
Abiomed, Inc. initiated a voluntary recall of the Abiomed Impella CP Set with SmartAssist (10th Generation) 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.
Which Products Are Affected
The affected product is the Abiomed Impella CP Set with SmartAssist (10th Generation) containing affected 14Fr Low Profile Introducer Kits 13 and 25 cm Japan, Product Code: 1000542. GTIN: 813502013467. Batch Number: 2041530. A total of 7 units are affected. Distribution includes US nationwide in the states of FL, IL, MN, NJ, NY, VA and Japan.
What You Should Do
Consumers with questions should contact the recalling firm, Abiomed, Inc., at 22 Cherry Hill Dr, Danvers, MA 01923-2575.
Why This Matters
This Class I recall involves a device distributed worldwide with potential for thrombus formation, a serious health risk.
Source
FDA recall number Z-2602-2026. Report date 20260701.
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 (1,037 characters here).
Similar severity timing
Same severity (high) notices issued closest in time to August 6, 2026.
Frequently Asked Questions
Common questions about this FDA recall.