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

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  Reason
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  Affected products

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