Abiomed Impella CP Set with SmartAssist 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 10 units of Impella CP Set with SmartAssist devices due to potential low purge pressure alarms that may interrupt mechanical circulatory support.
What this FDA recall tells you, and what most readers miss
This notice was issued by FDA on August 1, 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 certain Impella CP Set with SmartAssist devices after reports of exposure to low purge pressure occurrences that may result in persistent low purge pressure alarms and, in some cases, interruption or loss of mechanical circulatory support.
Which Products Are Affected
The recall involves 10 units of Impella CP Set with SmartAssist distributed in the United States to GA, IA, NE, PA, TX, WA, and WI, as well as internationally to Czech Republic, Norway, and Japan. Affected product codes are 1000080, 1000851, 0048-0014, and 0048-0024-JP. Specific serial numbers include: 1000080 (677223, 672986, 673252, 644591, 645428, 644314, 613525), 1000851 (636173), 0048-0014 (499250), and 0048-0024-JP (661216). GTIN: 00813502012279. Recall number Z-2457-2026. Classification: Class I. Recall initiation date: May 18, 2026.
What You Should Do
The recalling firm notified customers via letter. Healthcare providers and facilities with affected units should follow the firm's instructions regarding the ongoing recall.
Why This Matters
This Class I recall addresses a situation that may lead to interruption or loss of mechanical circulatory support in affected devices.
Source
FDA recall Z-2457-2026 - 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 (1,320 characters here).
Similar severity timing
Same severity (high) notices issued closest in time to August 1, 2026.
Frequently Asked Questions
Common questions about this FDA recall.