Abiomed Impella 5.5 Smart Assist Set 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 383 units of ABIOMED Impella 5.5 Smart Assist Sets due to potential introducer sheath leakage not visually detectable by 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 Impella pump sets after identifying a potential for introducer sheath leakage from under the sheath cap and along the hub score lines in 14Fr and 23Fr Introducers. These manufacturing issues are not visually detectable by the user.
Which Products Are Affected
The recall covers ABIOMED Impella 5.5 Smart Assist Set, JP, Pump Set Codes 1000211, 1000212 containing Introducer Product Code 0052-3006-JP. GTIN: 00813502012453. All current batches in field. A total of 383 units are affected. Distribution includes US Nationwide and worldwide to Australia, Austria, Belgium, Brazil, Brunei, Canada, China, Croatia, Czech Republic, Denmark, Finland, France, Germany, Greece, Hong Kong, Ireland, Israel, Italy, Japan, Kuwait, Luxembourg, Malaysia, Mexico, Netherlands, Norway, Panama, Poland, Saudi Arabia, Serbia, Slovenia, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, United Arab Emirates, and United Kingdom.
What You Should Do
The recall is classified as Class I and remains ongoing. Consumers with questions should refer to the recalling firm for guidance on affected units.
Why This Matters
The affected devices are heart pump sets distributed worldwide, and the leakage risk in provided introducers cannot be detected visually.
Source
FDA recall number Z-2687-2026, initiated June 11, 2026 by Abiomed, Inc., Danvers, MA.
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 (1,421 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.