Public recall detail

Maquet Percutaneous Insertion Kit and Dilator Sets

2026-08-26

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Health products Health product recall
Quick summary

Quick summary: Maquet Percutaneous Insertion Kit and Dilator Sets. Reason: Health product recall. Category: Health products. Date: 2026-08-26.

Recommended action

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

Recall details

Quick summary: Maquet Percutaneous Insertion Kit and Dilator Sets. Reason: Health product recall. Category: Health products. Date: 2026-08-26.

Official details

Affected product details

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

BrandMAQUET CARDIOPULMONARY GMBH
ProductMaquet Percutaneous Insertion Kit and Dilator Sets
IssueMedical devices - Sterility
Recall classType II
IdentificationRA-82527

Affected products

ProductDilator Sets
LotNot applicable.
ModelPIK DILATOR SET L
Serial numberNot applicable.
DescriptionDilator Sets
ProductPercutaneous Insertion Kit
LotNot applicable.
ModelPIK 150
Serial numberNot applicable.
DescriptionPercutaneous Insertion Kit

Issue

The manufacturer became aware of this issue during retrospective review of historical packaging verification documentation. It was identified that there have been failures in sterile barrier integrity verification testing. As these failures were not previously addressed in accordance with packaging verification requirements, the packaging may not consistently maintain sterile barrier integrity. Therefore, this FSCA is limited to all products of the PIK line within shelf-life.

What you should do

  • Contact the manufacturer if you require additional information.
Additional official information
AudienceHealthcare
CategoryHealth products - Medical devices - General hospital and personal use
CompaniesMaquet Cardiopulmonary GmbH Kehler Strasse 31, Rastatt, Germany, 76437
Recall date2026-07-28
Published byHealth Canada
Recall classType II
Alert / recall typeHealth product recall
Identification numberRA-82527
Background{}
CompaniesMaquet Cardiopulmonary GmbH Kehler Strasse 31, Rastatt, Germany, 76437
AudiencesHealthcare
Source updated2026-08-26

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

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