Cardiosave Intra-Aortic Balloon Pumps recalled due to battery failure

November 2, 2021 — Datascope/Getinge/Maquet is recalling its Cardiosave Hybrid/Rescue (IABP) intra-aortic balloon pumps due to reports that the batteries may fail. The U.S. Food and Drug Administration issued a notice this week stating that it is a Class I recall due to risk of serious injury or death.

CardioSave IABPs are cardiac assist hemodynamic support devices used in patients undergoing cardiac and non-cardiac surgery, and to treat adult patients with acute coronary syndrome or heart failure complications.

The company recalled the product due to the risk of battery failure and reduced run time due to substandard batteries that did not meet the performance specifications provided to customers. The seller has stated that these batteries may cause the device to shut down when running on battery power only.

If a patient requires life-saving treatment with an IABP and the device does not work or if treatment is stopped during use due to battery failure, the patient may suffer serious injury. , even fatal. The Cardiosave Hybrid and Rescue IABP monitors display battery life to the user, prompting the user to intervene with low battery alarms when alternate power sources are indicated.

Datascope/Getting/Maquet have reported receiving six complaints regarding this issue, but there have been no reports of injuries or fatalities related to this issue. However, there is potential for under-reporting because an end user reporting a faulty battery or short battery runtime may not know they originally received an inferior battery, the company said.

For more information read the recall notice.

List of all recalled serial numbers.

On September 21, 2021, Datascope/Getinge/Maquet sent an “Urgent Medical Device Removal” letter to customers asking them to:
• Immediately examine inventory to determine if there are Li-Ion Cardiosave batteries with part number/REF 0146-00-0097 and with serial numbers matching those listed at the top of the letter “Withdraw”. urgent medical device”.
• Replace any affected battery with an unaffected battery and remove the affected product from areas of use.
• Replace any affected battery with an unaffected battery and remove the affected product from areas of use.
• If you own the affected product, you are entitled to a credit or replacement at no charge for the establishment upon receipt of the response form enclosed with the “Urgent Medical Device Removal” letter.
• To get the free replacement battery, provide your shipping information and confirmation on page 4 that the defective battery will be disposed of once you receive the replacement battery.
• Dispose of affected batteries in accordance with local laws and the labeling on the battery pack.
• Forward this information to all current and potential users of Cardiosave Hybrid and Cardiosave Rescue IABP within your hospital or facility.
• Whether or not you have an affected product, please complete and sign the “Urgent Medical Device Removal” response form attached to the letter to confirm that they have received this notification and have properly disposed of the affected product.
• Return the completed form to Datascope/Getinge/Maquet by emailing a scanned copy to [email protected] or by FAX to (877)-446-3360.

The FDA has stated that healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to FDA MedWatch Safety Reporting System.

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