Maquet/Getinge Cardiosave Intra-Aortic Balloon Pump (IABP) by Getinge: Interruption and/or Inability to Start Therapy at Altitudes above 3,200 Feet/975 Meters
Date: September 20, 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., for a potential interruption and/or inability to start therapy to the patient regarding the use of certain Intra-Aortic Balloons (IABs) prior to or during the use with Cardiosave IABP for users who are at altitudes above 3200 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.
|Cardiosave Hybrid IABP
||March 06, 2012 to
August 31, 2018
|Cardiosave Rescue IABP
IABs used with the CS100 or CS300 IABPs are not affected by this issue. Interim immediate actions for consumers who have Cardiosave IABPs:
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:
|Sensation 34cc / 40cc,
Sensation Plus 40cc / 50cc
|-1,250 feet to 3,200 feet (795 mmHg to 676 mmHg) (1,060 hPa to 901 hPa)
-381 to 975 meters (795 mmHg to 676 mmHg) (1,060 hPa to 901 hPa)
||-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
Linear 25cc / 34cc / 40cc
|-1,250 feet to 12,000 feet (795 mmHg to 483 mmHg) (1,060 hPa to 644 hPa)
-381 to 3,657 meters (795 mmHg to 483 mmHg) (1,060 hPa to 644 hPa)
For Japan users only
|Balloon Name and Size:
|TransRay 34cc / 40cc,
TransRay Plus 35cc / 40cc
|-381 to 975 meters (795 mmHg to 676 mmHg) (1,060 hPa to 901 hPa)
|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 + 1 973 709 7967, Monday through Friday, between the hours of 8:00 a.m. and 6:00 p.m. EST. or via e-mail at Helena.firstname.lastname@example.org.
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