Abiomed Impella 5.5 SmartAssist S2 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 1,574 units of the Impella 5.5 SmartAssist S2 Set due to potential introducer sheath leakage.
What this FDA recall tells you, and what most readers miss
This notice was issued by FDA on August 10, 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, MedicalDevices.
What Happened
Abiomed, Inc. initiated a recall due to 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 affects ABIOMED Impella 5.5 SmartAssist S2 Set, JP, Pump Set Codes 1000459, 1000460; containing Introducer Product Code 0052-3006-JP. GTIN: 00813502013054. All current batches in field. A total of 1,574 units are affected. Distribution was worldwide, including US Nationwide and the following countries: 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
Consumers and healthcare providers should follow the recall instructions provided by the recalling firm.
Why This Matters
This Class I recall involves a heart pump and accessories distributed worldwide, with the potential for undetected leakage in provided introducers.
Source
FDA Recall Z-2688-2026 - 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 (1,360 characters here).
Similar severity timing
Same severity (high) notices issued closest in time to August 10, 2026.
Frequently Asked Questions
Common questions about this FDA recall.