Class 1 Recall: Maquet Datascope Corp./Getinge Group Recalls the Cardiosave Hybrid and Cardiosave Rescue Intra-Aortic Balloon Pumps (IABPs) Due to Possible Malfunction and Failure at High Altitudes
The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death.
Wed Nov 07 2018
Recalled Product
- Name: Cardiosave Hybrid and Cardiosave Rescue Intra-Aortic Balloon Pumps (IABPs)
- Serial numbers: All Serial Numbers manufactured from December 12, 2011 and ongoing are affected
- Model/Product UPN Codes:
- Cardiosave Hybrid: 0998-00-0800-XX
- Cardiosave Rescue: 0998-UC-0800-XX
- Manufacturing Dates: All units manufactured since December 12, 2011 and ongoing
- Distribution Dates: March 6, 2012 to August 31, 2018
- Devices recalled in the U.S: 2876 units
Device Use
The Cardiosave Hybrid and Cardiosave Rescue Intra-Aortic Balloon Pumps (IABPs) are cardiac assist devices used with patients undergoing cardiac and non-cardiac surgery, and to treat patients with acute coronary syndrome or complications from heart failure.
Reason for Recall
Maquet Datascope Corp. is recalling the Cardiosave Hybrid and Cardiosave Rescue IABPs due to the potential of the autofill process to malfunction or fail during use at altitudes above 3200 feet. This failure may result in either interruption or cessation of therapy upon the first maintenance autofill or the inability to start therapy.
Who May be Affected
- Health care providers who use the Cardiosave Hybrid and Cardiosave Rescue IABPs.
- Patients receiving circulatory support with a Maquet Datascope Corp.'s Cardiosave Hybrid and Cardiosave Rescue IABPs.
What to Do
On September 24, 2018, Maquet Datascope Corp. issued an Urgent Device Correction letter to all device consignees along with an Instructions for Use Addendum. The letter instructed users to follow the operating altitudes permissible for certain intra-aortic balloons, as specified below for the Cardiosave Hybrid and Cardiosave Rescue IABPs:
| Balloon Name and Size | Operating Altitude |
|---|---|
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Alternatively, use a Cardiosave CS100 or CS300 IABP, since they are not affected by this issue.
Maquet/Getinge is also currently developing a software correction to address this issue. Maquet/Getinge anticipates installing the updated software beginning in February 2019. A Maquet/Getinge Service representative will contact customers to schedule software installation at no cost.
Contact Information
Customers with questions may contact Maquet Datascope Corp's Technical Support Department at 1-888-627-8383 (press option 3), Monday through Friday, between 8:00 am and 6:00 pm Eastern Standard Time.
Date Recall Initiated
September 20, 2018
How Do I Report a Problem?
Health care professionals and consumers may report adverse reactions or quality problems they experience using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program either online, by regular mail or by FAX to 1-800-FDA-0178.