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.
| AFFECTED PRODUCT | PART NUMBER | DISTRIBUTION DATE |
|---|---|---|
| Cardiosave Hybrid IABP | 0998-00-0800-XX |
March 06, 2012 to |
| 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:
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: |
|---|---|
|
-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) | |
|
-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: | Operating Altitude: |
|---|---|
|
-381 to 975 meters (795 mmHg to 676 mmHg) (1,060 hPa to 901 hPa) |
|
|
|
-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.swan@getinge.com.
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.
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