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 32,934 units of the Abiomed REF 0052-3006 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 11, 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 voluntary recall of the Abiomed Introducer Kit for Impella due to manufacturing issues that could 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: 0052-3006, Introducer Kit for Impella Hemostatic Peel Away Introducer System with Infusion Sideport, 23F. A total of 32,934 units are involved. Distribution was limited to the US state of MA. All lots within expiry are affected (GTIN: 00885672009755/00813502011609). The recall number is Z-2680-2026.
What You Should Do
No specific consumer action steps are provided in the recall notice. Healthcare providers and facilities should follow standard procedures for handling recalled medical devices.
Why This Matters
This Class I recall involves a device used with heart pumps and accessories distributed in Massachusetts, with potential for leakage due to manufacturing issues.
Source
FDA recall Z-2680-2026, event ID 99102. 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 (1,127 characters here).
Similar severity timing
Same severity (high) notices issued closest in time to August 11, 2026.
Frequently Asked Questions
Common questions about this FDA recall.