Public recall detail

Cardiosave System - Hybrid & Rescue Intra-Aortic Balloon Pump

2023-01-04

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Recall Safety notice
Quick summary

Quick summary: Cardiosave System - Hybrid & Rescue Intra-Aortic Balloon Pump. Date: 2023-01-04.

Recommended action

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

Recall details

Quick summary: Cardiosave System - Hybrid & Rescue Intra-Aortic Balloon Pump. Date: 2023-01-04.

Official details

Affected product details

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

BrandDatascope Corp.
ProductCardiosave System - Hybrid & Rescue Intra-Aortic Balloon Pump
IssueMedical devices - Performance
Recall classType II
IdentificationRA-72511

Affected products

ProductCardiosave System - Hybrid & Rescue Intra-Aortic Balloon Pump
LotMore than 10 numbers, contact manufacturer.
Model0998-00-0800-XX
Serial numberMore than 10 numbers, contact manufacturer.
DescriptionCardiosave System - Hybrid & Rescue Intra-Aortic Balloon Pump

Issue

Datascope/Getinge has received complaints reporting unexpected shutdown of the Cardiosave IABP while providing therapy in very rare instances. An internal investigation of the complaints determined an unexpected shutdown may be due to blood entering into the Cardiosave IABP when therapy is provided with a perforated intra-aortic balloon catheter. Recall start date: December 21, 2022

What you should do

  • Contact the manufacturer if you require additional information.
Additional official information
AudienceHealthcare
CategoryHealth products - Medical devices - Cardiovascular
CompaniesDatascope Corp. 1300 Macarthur Blvd., Mahwah, New Jersey, United States, 07430
Published byHealth Canada
Recall classType II
Alert / recall typeHealth product recall
Identification numberRA-72511
Background{}
CompaniesDatascope Corp. 1300 Macarthur Blvd., Mahwah, New Jersey, United States, 07430
AudiencesHealthcare
Source updated2023-01-04

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

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