Health Canada29 Jun 2026
Abiomed Introducer Kits with Impella Heart Pumps
Health Canada published a recall notice for Abiomed Introducer Kits with Impella Heart Pumps on 29 Jun 2026. It is one of 311 notices of this kind from Health Canada since 2 Apr 2026 in AreaZine's record.
Recall
The recall notice
- Issued by
- Health Canada
- Issued
- 29 Jun 2026
- Recall type
- Health product recall
- Companies
- Abiomed Inc.22 Cherry Hill Drive, Danvers, Massachusetts, United States, 01923
- Official source
- Health Canada: the notice at its source
The latest from Health CanadaEvery warning and recall in Canada
Source: Health Canada: the notice at its source. AreaZine rebuilds this page from the agency's record; the agency's page is the one to act on. Contains information licensed under the Open Government Licence – Canada.
The notice as issued
Issue: 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. This information is provided to support appropriate clinical awareness, monitoring, and patient support as needed. The identified defect does not affect any other packaged products within the pump set. Additional information Details Original published date: 2026-06-29 Affected products: Affected products Lot or serial number Model or catalogue number Impella CP Introducer Kit All lots. 0052-0039 Impella CP Introducer Kit All lots. 1000550 Impella CP Introducer Kit All lots. 0052-0038 Introducer Kit 23 Fr For Impella RP All lots. 0052-0002 Impella RP Flex With Smartassist Pump Set All lots. 1000441 Impella RP Flex With Smartassist Pump Set All lots. 1000323 Impella RP Flex With Smartassist Pump Set All lots. 2000342 Axillary Insertion Kit All lots. 0052-0011 Axillary Insertion Kit All lots. 0052-0011-CA
Source: Health Canada: the notice at its source. The text is the agency's, unedited. Contains information licensed under the Open Government Licence – Canada.