Abiomed Introducer Kit for Impella Recall
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Oscor Inc. is recalling 355 units of the Abiomed REF 0052-3025 Introducer Kit for Impella due to potential leakage from manufacturing issues.
What this FDA recall tells you, and what most readers miss
This notice was issued by FDA on August 10, 2026 and geographically references Massachusetts. 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
Oscor Inc. has initiated a voluntary recall of the Abiomed Introducer Kit for Impella due to manufacturing issues that may cause the 14Fr and 23Fr introducer sheaths to leak from the sidearm, under the sheath cap, and along the hub score lines in the hub region.
Which Products Are Affected
The affected product is Abiomed REF: 0052-3025, Introducer Kit for Impella Hemostatic Peel Away Introducer System with Infusion Sideport, 14F 13cm and 25cm, heart pump and accessories. A total of 355 units are affected. All lots within expiry with GTIN 00885672009793 and 00813502010664 are included. Distribution was limited to the US state of MA.
What You Should Do
Consumers should contact the recalling firm for return or refund instructions. The recall number is Z-2678-2026.
Why This Matters
This Class I recall involves a medical device accessory used with heart pumps, where leakage could impact device performance.
Source
FDA recall number Z-2678-2026, event ID 99102.
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 (1,001 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.