Abiomed Impella CP Introducer Kit 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 1,223 units of the ABIOMED Impella CP Introducer Kit 14 Fr 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 Introducer Kit due to a potential for introducer sheath leakage from under the sheath cap and along the hub score lines in 14Fr and 23Fr Introducers. These manufacturing issues are not visually detectable by the user.
Which Products Are Affected The recall involves the ABIOMED Impella CP Introducer Kit 14 Fr, 25 cm, Pump Set Code 0052-0039, containing Kit, 14Fr Introducer, 25cm, Long Taper, Introducer Product Code 0052-3053. GTINs: 00813502011715, 00813502012736. All current batches in field. A total of 1,223 units are affected. Distribution is 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. Recall number Z-2686-2026. Classification: Class I.
What You Should Do The source data does not specify consumer action steps.
Why This Matters The recall affects medical devices distributed worldwide and classified as Class I, indicating a reasonable probability of serious adverse health consequences.
Source FDA recall Z-2686-2026, recalling firm Abiomed, Inc., Danvers, MA.
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 (1,477 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.