Abiomed Impella 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 17 units of the 14 Fr x 25 cm Low Profile Introducer Kit for Impella CP due to potential thrombus formation during prolonged use.
What this FDA recall tells you, and what most readers miss
This notice was issued by FDA on August 5, 2026 and geographically references United States. 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 the Abiomed 14 Fr x 25 cm Low Profile Introducer Kit for Impella CP because of the potential for thrombus formation during prolonged use of the introducer.
Which Products Are Affected
The recall involves the Impella Set Product Code: 1000435 (GTIN: 00813502013009) and Introducer Product Code: 1000435 with batch numbers 2038707 and 2045782. A total of 17 units are affected. Distribution was limited to the states of FL, IL, MN, NJ, NY, VA and Japan.
What You Should Do
The recall was initiated by the firm via letter. Customers should follow instructions provided in the notification from Abiomed, Inc.
Why This Matters
This Class I recall addresses a serious risk associated with the medical device in limited distribution.
Source
FDA recall number Z-2600-2026. Data from FDA enforcement report.
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 (877 characters here).
Similar severity timing
Same severity (high) notices issued closest in time to August 5, 2026.
Frequently Asked Questions
Common questions about this FDA recall.