Health product recall

CARDIOSAVE SYSTEM - HYBRID & RESCUE INTRA-AORTIC BALLOON PUMP (2021-09-14)

Starting date:
September 14, 2021
Posting date:
September 24, 2021
Type of communication:
Medical Device Recall
Subcategory:
Medical Device
Hazard classification:
Type II
Source of recall:
Health Canada
Issue:
Medical Devices
Audience:
General Public, Healthcare Professionals, Hospitals
Identification number:
RA-76501

Last updated:
2021-09-24

Affected Products

CARDIOSAVE SYSTEM - HYBRID & RESCUE INTRA-AORTIC BALLOON PUMP

Reason

1. In the presence of radiated RF disturbances, the Helium indicator on the cardiosave IABP would intermittently over-report the remaining helium capacity.
2. The Cardiosave IABP may unexpectedly shut down when the device is running on AC power, only one battery is inserted in the IABP, and the battery is physically removed while the battery is being charged.

Affected products

CARDIOSAVE SYSTEM - HYBRID & RESCUE INTRA-AORTIC BALLOON PUMP

Lot or serial number

More than 10 numbers, contact manufacturer

Model or catalog number

0998-00-0800-XX

Companies
Manufacturer

Datascope Corp.

1300 Macarthur Blvd.

Mahwah

07430

New Jersey

UNITED STATES