Abiomed Introducer Kit for Impella Recall
Areazine synthesizes this FDA recall directly from FDA's official public data feed. See our methodology for full source attribution and refresh cadence.
Oscor Inc. is recalling 1,332 units of the Abiomed REF 0052-3021 Introducer Kit due to potential leakage from the introducer sheaths.
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. initiated a recall due to manufacturing issues creating a potential for 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
Abiomed REF: 0052-3021, Introducer Kit for Impella Hemostatic Peel Away Introducer System with Infusion Sideport, 14F, 23F heart pump and accessories. 1,332 units. All lots within expiry. GTIN: 00885672009786/00813502010558. Distributed in the US state of MA. Recall number Z-2679-2026. Classification: Class I.
What You Should Do
No specific consumer action steps are provided in the recall data.
Why This Matters
The Class I recall affects 1,332 units distributed in Massachusetts and indicates a situation in which there is a reasonable probability that the use of the device will cause serious adverse health consequences.
Source
FDA recall event ID 99102, report date 20260722, recalling firm Oscor Inc., Palm Harbor, FL.
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 (1,004 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.