Public recall detail

Abiomed Introducer Kits with Impella Heart Pumps

2026-06-29

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Health products Health product recall
Quick summary

Quick summary: Abiomed Introducer Kits with Impella Heart Pumps. Reason: Health product recall. Category: Health products. Date: 2026-06-29.

Recommended action

Recommended action: compare your product with the official notice and follow the instructions published by the official source.

Recall details

Quick summary: Abiomed Introducer Kits with Impella Heart Pumps. Reason: Health product recall. Category: Health products. Date: 2026-06-29.

Official details

Affected product details

Structured information extracted from the official recall notice. Confirm the identifiers and instructions in the original notice.

BrandAbiomed Inc.
ProductAbiomed Introducer Kits with Impella Heart Pumps
IssueMedical devices - Performance
Recall classType I
IdentificationRA-82261

Affected products

ProductImpella CP Introducer Kit
LotAll lots.
Model0052-0039
Serial numberAll lots.
DescriptionImpella CP Introducer Kit
ProductImpella CP Introducer Kit
LotAll lots.
Model1000550
Serial numberAll lots.
DescriptionImpella CP Introducer Kit
ProductImpella CP Introducer Kit
LotAll lots.
Model0052-0038
Serial numberAll lots.
DescriptionImpella CP Introducer Kit
ProductIntroducer Kit 23 Fr For Impella RP
LotAll lots.
Model0052-0002
Serial numberAll lots.
DescriptionIntroducer Kit 23 Fr For Impella RP
ProductImpella RP Flex With Smartassist Pump Set
LotAll lots.
Model1000441
Serial numberAll lots.
DescriptionImpella RP Flex With Smartassist Pump Set
ProductImpella RP Flex With Smartassist Pump Set
LotAll lots.
Model1000323
Serial numberAll lots.
DescriptionImpella RP Flex With Smartassist Pump Set
ProductImpella RP Flex With Smartassist Pump Set
LotAll lots.
Model2000342
Serial numberAll lots.
DescriptionImpella RP Flex With Smartassist Pump Set
ProductAxillary Insertion Kit
LotAll lots.
Model0052-0011
Serial numberAll lots.
DescriptionAxillary Insertion Kit
ProductAxillary Insertion Kit
LotAll lots.
Model0052-0011-CA
Serial numberAll lots.
DescriptionAxillary Insertion Kit
ProductImpella 5.5 Set With Smartassist
LotAll lots.
Model0550-0004
Serial numberAll lots.
DescriptionImpella 5.5 Set With Smartassist
ProductImpella 5.5 Set With Smartassist
LotAll lots.
Model1000551
Serial numberAll lots.
DescriptionImpella 5.5 Set With Smartassist
ProductImpella CP Smart Assist Set, Canada
LotAll lots.
Model0048-0044
Serial numberAll lots.
DescriptionImpella CP Smart Assist Set, Canada

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.

What you should do

  • Contact the manufacturer if you require additional information.
Additional official information
AudienceHealthcare
CategoryHealth products - Medical devices - Cardiovascular
CompaniesAbiomed Inc.22 Cherry Hill Drive, Danvers, Massachusetts, United States, 01923
Recall date2026-06-22
Published byHealth Canada
Recall classType I
Alert / recall typeHealth product recall
Identification numberRA-82261
Background{}
CompaniesAbiomed Inc.22 Cherry Hill Drive, Danvers, Massachusetts, United States, 01923
AudiencesHealthcare
Source updated2026-06-29

Contains information licensed under the Open Government Licence – Canada. SafetyPulse is independent of the Government of Canada.

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