COMPANY ANNOUNCEMENT
Getinge Issues Worldwide Voluntary Correction of Maquet/Getinge Cardiosave Intra-Aortic Balloon Pump (IABP) For Interruption and/or Inability to Start Therapy at Altitudes Above 3,200 Feet/975 Meters
When a company announces a recall, market withdrawal, or safety alert, the FDA posts the company's announcement as a public service. FDA does not endorse either the product or the company.
Read AnnouncementSummary
- Company Announcement Date:
- FDA Publish Date:
- Product Type:
- Medical Devices
Cardiovascular - Reason for Announcement:
-
Recall Reason DescriptionPotential interruption and/or inability to start therapy to the patient
- Company Name:
- Getinge
- Brand Name:
-
Brand Name(s)Cardiosave
- Product Description:
-
Product DescriptionMaquet/Getinge Cardiosave Intra-Aortic Balloon Pumps (IABP)
Company Announcement
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 August 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:
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, 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) |
| 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 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: | Operating Altitude: |
|---|---|
| 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.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.
- Complete and submit the report Online: www.fda.gov/medwatch/report.htm
- Regular Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm
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.