Abiomed Impella CP Set Recall Due to Sheath Leakage
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Abiomed, Inc. is recalling 35,430 units of ABIOMED Impella CP Set worldwide due to potential introducer sheath leakage.
What this FDA recall tells you, and what most readers miss
This notice was issued by FDA on August 10, 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, medical-devices.
What Happened
Abiomed, Inc. initiated a voluntary recall of the ABIOMED Impella CP Set after identifying a potential for introducer sheath leakage from under the sheath cap and along the hub score lines in 14Fr and 23Fr Introducers. The manufacturing issues are not visually detectable by the user.
Which Products Are Affected
The recall covers ABIOMED Impella CP Set, Pump Set Code 0048-0014, containing Introducer Product Code 0052-3046. Affected GTINs are 00813502012873, 00813502013344, 00813502013368, and 04260113630280. All current batches in the field are included. A total of 35,430 units are affected. Distribution was worldwide, including US Nationwide and the following countries: Australia, Austria, Belgium, Brazil, Brunei, Canada, China, Croatia, Czech Republic, Denmark, Finland, France, Germany, Greece, Hong Kong, Ireland, Israel, Italy, Japan, Kuwait, Luxembourg, Malaysia, Mexico, Netherlands, Norway, Panama, Poland, Saudi Arabia, Serbia, Slovenia, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, United Arab Emirates, and United Kingdom.
What You Should Do
This is a firm-initiated voluntary recall classified as Class I. Healthcare providers and facilities should follow instructions provided by Abiomed, Inc. for the affected devices.
Why This Matters
This Class I recall involves a heart pump and accessories distributed globally, with the potential for an undetected manufacturing defect.
Source
FDA recall number Z-2689-2026. Event ID 98893. Recalling firm: Abiomed, Inc., 22 Cherry Hill Dr, Danvers, MA 01923-2575.
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 (1,572 characters here).
Similar severity timing
Same severity (high) notices issued closest in time to August 10, 2026.
Frequently Asked Questions
Common questions about this FDA recall.