Abiomed Introducer Kit 23 Fr 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 196 units of the ABIOMED Introducer Kit 23 Fr due to potential sheath leakage not visible to users.
What this FDA recall tells you, and what most readers miss
This notice was issued by FDA on August 11, 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, Devices.
What Happened
Abiomed, Inc. initiated a voluntary recall of certain introducer kits after identifying a potential for introducer sheath leakage from under the sheath cap and along the hub score lines in 23Fr Introducers. These manufacturing issues are not visually detectable by the user.
Which Products Are Affected
The recall affects the ABIOMED Introducer Kit 23 Fr, 11 cm, Pump Set Code 1000441, containing Kit, 23Fr Introducer, 11cm, Sterile, Introducer Product Code 2000342. GTIN: 00813502012910. All current batches in field. A total of 196 units are affected. Distribution was worldwide, including US Nationwide and multiple countries.
What You Should Do
Consumers should follow instructions provided in the firm's notification letter regarding the recalled devices.
Why This Matters
This Class I recall involves heart pump accessories where undetected leakage could pose serious risks during use.
Source
FDA recall number Z-2684-2026
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 (961 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.