Cardiosave Hybrid IABP (2018-09-26)

Starting date:

September 26, 2018

Posting date:

November 2, 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-68182

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  Reason
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  Affected products

Affected products

Cardiosave Hybrid IABP

Reason

Maquet/Getinge has received complaints involving the Cardiosave IABPs regarding the use of certain Intra-Aortic Balloons (IABs) at altitudes above 975 Meters. The Cardiosave may not successfully complete the autofill process required to initiate pumping. This failure may result in either interruption of therapy upon the first maintenance autofill or the inability to start therapy. This condition could potentially lead to patient hemodynamic instability. There have been no adverse events or deaths attributed to this issue. IABs used with the CS100 or CS300IAPB are not affected by the issue.

Affected products