News | Intra-Aortic Balloon Pumps (IABP) | September 24, 2018

Getinge Issues Worldwide Voluntary Correction of Maquet/Getinge Cardiosave Intra-Aortic Balloon Pump

Company reports device may interrupt or be unable to start therapy at altitudes above 3,200 feet; users cautioned to follow advised operating altitudes

Getinge Issues Worldwide Voluntary Correction of Maquet/Getinge Cardiosave Intra-Aortic Balloon Pump

September 24, 2018 — Getinge is voluntarily initiating a worldwide recall involving a field correction of approximately 5,223 Maquet/Getinge Cardiosave Intra-Aortic Balloon Pumps (IABP) sold by Datascope Corp. The correction involves a potential interruption and/or inability to start therapy to the patient regarding the use of certain IABs prior to or during the use with Cardiosave IABP for users who are at altitudes above 3,200 feet/975 meters. This condition could potentially lead to patient hemodynamic instability.

It is important to note, there have been no adverse events or deaths attributed to this issue.

Affected Product
Part Number
Distribution Date

Cardiosave Hybrid IABP
0998-00-0800-XX
March 6, 2012 to Aug. 31, 2018

Cardiosave Rescue IABP
0998-UC-0800-XX

IABs used with the CS100 or CS300 IABPs are not affected by this issue. Interim immediate actions for consumers who have Cardiosave IABPs include:

The only action to be taken by the user for this issue is to follow the operating altitudes as specified below for the Cardiosave IABP.

Balloon Name and Size
Operating Altitude

Sensation 34cc / 40cc,
-1,250 feet to 3,200 feet (795 mmHg to 676 mmHg) (1,060 hPa to 901 hPa)

Sensation Plus 40cc / 50cc
-381 to 975 meters (795 mmHg to 676 mmHg) (1,060 hPa to 901 hPa)

Mega 50cc
-1,250 feet to 5,000 feet (795 mmHg to 632 mmHg) (1,060 hPa to 843 hPa)

-381 to 1,524 meters (795 mmHg to 632 mmHg) (1,060 hPa to 843 hPa)

Mega 30cc / 40cc
-1,250 feet to 12,000 feet (795 mmHg to 483 mmHg) (1,060 hPa to 644 hPa)

Linear 25cc / 34cc / 40cc
-381 to 3,657 meters (795 mmHg to 483 mmHg) (1,060 hPa to 644 hPa

 

For Japan users only

Balloon Name and Size
Operating Altitude

TransRay 34cc / 40cc,
-381 to 975 meters (795 mmHg to 676 mmHg) (1,060 hPa to 901 hPa)

TransRay Plus 35cc / 40cc

Yamato Plus N or R 30cc / 35cc / 40cc
-381 to 3,657 meters (795 mmHg to 483 mmHg) (1,060 hPa to 644 hPa)

Alternatively, use a CS100 or CS300 IABP since they are not affected by this issue.

Maquet/Getinge is currently developing a software correction to address the altitude issue. Maquet/Getinge anticipates the installation of the updated software to begin February 2019. A Maquet/Getinge Service representative will contact affected customers to schedule the installation of the updated software.

Customers with questions may contact the company via telephone (973) 709-7967, Monday through Friday, between the hours of 8 a.m. and 6 p.m. EST. or via e-mail at [email protected]

Adverse reactions or quality problems experiences with the use of this product may be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178.

For more information: www.getinge.com

Read about the warning letter about Maquet IABPs shutting off while operationg on battery power (Nov. 1, 2018)

 

 

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