Abiomed Introducer Kits with Impella Heart Pumps Recall
Areazine synthesizes this Health Canada recall directly from Health Canada's official public data feed. See our methodology for full source attribution and refresh cadence.
Abiomed has initiated a voluntary medical device recall for Introducer Kits used with Impella heart pumps due to potential sheath leakage that may impair hemostasis and increase bleeding risk.
What this Health Canada recall tells you, and what most readers miss
This notice was issued by Health Canada on August 1, 2026 and geographically references Canada. 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 - Product & Food 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, health-canada, MedicalDevices.
What Happened
Abiomed has initiated a voluntary medical device recall (correction) for all currently distributed Introducer kits that are used with Impella heart pumps to notify customers of a potential for unexpected introducer sheath leakage from the sidearm and under the sheath cap and along the hub score lines in the hub region. Introducer leakage may impair hemostasis and increase the risk of access-site bleeding, particularly in anticoagulated patients.
Which Products Are Affected
- Impella CP Introducer Kit, model/catalogue numbers 0052-0039, 1000550, 0052-0038 (all lots)
- Introducer Kit 23 Fr For Impella RP, model/catalogue number 0052-0002 (all lots)
- Impella RP Flex With Smartassist Pump Set, model/catalogue numbers 1000441, 1000323, 2000342 (all lots)
- Axillary Insertion Kit, model/catalogue numbers 0052-0011, 0052-0011-CA (all lots)
The identified defect does not affect any other packaged products within the pump set. The company is Abiomed Inc., 22 Cherry Hill Drive, Danvers, Massachusetts, United States, 01923.
What You Should Do
This information is provided to support appropriate clinical awareness, monitoring, and patient support as needed.
Why This Matters
Introducer leakage may impair hemostasis and increase the risk of access-site bleeding, particularly in anticoagulated patients.
Source
Health Canada - Original published date: 2026-06-29
Original source: Health Canada Official Notice ↗
Related Product & Food Recalls
All Product & Food Recalls →Nationwide notices with similar length or severity timing 8
Two Areazine-derived peer sets for this Health Canada 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 (1,499 characters here).
Similar severity timing
Same severity (high) notices issued closest in time to August 1, 2026.
Frequently Asked Questions
Common questions about this Health Canada recall.