Abiomed Impella CP Set Recall Due to Leakage Risk
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 87,277 units of the 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-device.
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. This is a Class I recall.
Which Products Are Affected
The recall affects the ABIOMED Impella CP Set, Pump Set Code 0048-0003, containing BIOMED Impella Introducer, 14 Fr, 13 cm & 25 cm, Product Code 0052-3046. GTINs: 00813502012279, 00813502011876. All current batches in field. A total of 87,277 units are affected. Distribution includes US Nationwide and worldwide to 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. Recall number: Z-2682-2026.
What You Should Do
No specific consumer instructions are provided in the recall notice.
Why This Matters
The recall involves a Class I medical device distributed worldwide, with potential leakage issues that are not visually detectable.
Source
FDA recall Z-2682-2026. 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 (1,381 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.