Abiomed Impella RP Flex Recall Due to Sheath Leakage
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. recalls 5,017 units of the Impella RP Flex with SmartAssist Set (Pump Set Code 1000323) for potential introducer sheath leakage.
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, medical-devices.
What Happened
A potential for introducer sheath leakage from under the sheath cap and along the hub score lines, identified in 14Fr and 23Fr Introducers. These manufacturing issues are not visually detectable by the user.
Which Products Are Affected
ABIOMED Impella RP Flex with SmartAssist Set, Pump Set Code 1000323, containing Kit, 23Fr Introducer, 11cm, Sterile, 23 Fr, 11 cm, Product Code 2000342. GTIN 00813502012811. All current batches in field. 5,017 units. Worldwide distribution including US Nationwide and multiple countries.
What You Should Do
The manufacturing issues are not visually detectable by the user. Refer to the recall notice for further guidance.
Why This Matters
This is a Class I recall involving heart pump accessories distributed worldwide.
Source
FDA recall number Z-2681-2026, event ID 98893.
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 (842 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.