Health product recall

CARDIOSAVE Intra-Aortic Balloon Pump (IABP) (2018-05-08)

Starting date:
May 8, 2018
Posting date:
May 25, 2018
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-66886

Affected products

CARDIOSAVE Intra-Aortic Balloon Pump (IABP)

Reason

Maquet/Getinge has received complaints involving the CARDIOSAVE IABPs regarding ingress of fluids into the IABP affecting various electronic circuit boards. This situation would prevent initiation or continuation of therapy.

Affected products

CARDIOSAVE Intra-Aortic Balloon Pump (IABP)

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

UNITED STATES