Public recall detail

Datascope Cardiosave Hybrid And Rescue Intra-Aortic Balloon Pumps (IABP)

2023-06-16

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Recall Safety notice
Quick summary

Quick summary: Datascope Cardiosave Hybrid And Rescue Intra-Aortic Balloon Pumps (IABP). Date: 2023-06-16.

Recommended action

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

Recall details

Quick summary: Datascope Cardiosave Hybrid And Rescue Intra-Aortic Balloon Pumps (IABP). Date: 2023-06-16.

Official details

Affected product details

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

BrandDatascope Corp.
ProductDatascope Cardiosave Hybrid And Rescue Intra-Aortic Balloon Pumps (IABP)
IssueMedical devices - Performance
Recall classType II
IdentificationRA-73832

Affected products

ProductDatascope Cardiosave Hybrid And Rescue Intra-Aortic Balloon Pumps (IABP)
LotMore than 10 numbers, contact manufacturer.
Model0998-00-0800-XX
Serial numberMore than 10 numbers, contact manufacturer.
DescriptionDatascope Cardiosave Hybrid And Rescue Intra-Aortic Balloon Pumps (IABP)

Issue

Issue 1: There have been reports of IABP units losing the ability to charge batteries in one or both bay slots due to a failure in the power management board charging path circuitry due to damage to the component from a previous electrical surge. Therapy may be interrupted if batteries fail to charge and the device is disconnected from ac power. Low battery alarms may alert the user to the issue prior to interruption of therapy. Issue 2: An unexpected shutdown of the IABP may occur due to failures of tantalum capacitors in the power management board and/or solenoid board. This issue may lead to an unexpected interruption of therapy. Recall start date: June 9, 2023

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-73832
Background{}
CompaniesDatascope Corp. 1300 Macarthur Blvd., Mahwah, New Jersey, United States, 07430
AudiencesHealthcare
Source updated2023-06-16

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

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