FDA Class I Recall of CardioSave Hybrid/Rescue IABPs
Datascope/Getinge/Maquet is recalling CardioSave Hybrid and Rescue intra-aortic balloon pumps (IABP) because some battery packs may have a shortened run-time and fail unexpectedly, according to a medical device recall notice posted on the US Food and Drug Administration (FDA) website.
The FDA has identified this as a class I recall, the most serious type of recall, because of the risk for serious injury or death.
The recalled IABPs have substandard batteries that do not meet performance specifications and were mistakenly released to a limited number of customers.
If a patient requires life-supporting therapy with an IABP and the device does not work or stops working during use because of battery failure, the patient will be at risk for serious injury, including death, the FDA cautions.
Both IABP monitors display battery life and have low battery alarms when alternative power sources are needed.
Datascope/Getting/Maquet has received six complaints but no reports of injury or death related to this issue.
“However, there is a potential for under reporting since the end user reporting a failed battery or short battery-run time cannot be aware that they originally received a substandard battery,” the FDA said.
The recall involves 137 battery packs distributed in the United States between September 23, 2017 and August 17, 2021. Product codes and lot numbers are available in the recall notice.
The company sent an urgent medical device removal letter to customers requesting that they check inventory to determine if there are any CardioSave LiIon battery packs with part number/reference number 0146-00-0097 and with serial numbers listed in the letter.
Customers are asked to replace any affected battery with an unaffected battery and remove affected product from areas of use.
The company will issue credit or a replacement battery at no cost to the facility upon receipt of the response form attached to the letter.
Distributors who shipped any affected product to customers are asked to forward the device removal letter to customers.
All customers, regardless of whether or not they have defective batteries, are asked to complete and sign the response form to acknowledge that they received the notification and disposed of the affected batteries.
Completed forms can be scanned and emailed to Datascope/Getinge/Maquet at [email protected] or by FAX to 1-877-446-3360.
Customers who have questions about this recall should contact their Datascope/Getinge/Maquet sales representative or, for technical questions, customer service (1-888-943-8872, option 2), Monday through Friday, 8:00 AM to 6:00 PM ET.
Any adverse events or suspected adverse events related to the recalled CardioSave Hybrid/Rescue IABPs should be reported to the FDA through MedWatch, its adverse-event reporting program.
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