FDA MedWatch - Cardiosave Hybrid/Rescue Intra-Aortic Balloon Pump Battery Packs by Datascope/Getinge/Maquet:

Class I Recall - Due to Risk of Battery Failure

If your email program has trouble displaying this email, view as a webpage. MedWatch - The FDA Safety Information and Adverse Event Reporting Program TOPIC: Cardiosave Hybrid/Rescue Intra-Aortic Balloon Pump (IABP) Battery Packs by Datascope/Getinge/Maquet: Class I Recall - Due to Risk of Battery Failure AUDIENCE: Patient, Health Professional, Risk Manager, Cardiology ISSUE: Datascope/Getinge/Maquet is recalling this product due to the risk of the battery failing and having a shortened run-time due to substandard batteries not meeting performance specifications being released to customers, which may cause the device to stop working when operated by battery only. If a patient requires life-supporting therapy with an IABP and the device does not work or if therapy is stopped during use due to battery failure, the patient will be at risk of serious injury, including death. Both Cardiosave Hybrid and Rescue IABP monitors display battery life to the user, prompting intervention with low battery alarms when alternative power sources are indicated.  Datascope/Getting/Maquet reports receiving six complaints, and no reports of injuries or deaths related to this issue. However, there is a potential for underreporting since the end user reporting a failed battery or short battery-run time cannot be aware that they originally received a substandard battery.  For more information about this recall, click on the red button "Read Recall" below. BACKGROUND: The CardioSave Hybrid/Rescue IABP are cardiac (heart) assist devices used with patients undergoing cardiac and non-cardiac surgery, and to treat adult patients who have acute coronary syndrome or complications of heart failure. RECOMMENDATIONS: On September 21, 2021, Datascope/Getinge/Maquet sent an "Urgent Medical Device Removal" letter to customers requesting that they:  Examine inventory immediately to determine if there are any Cardiosave Li-Ion Battery Packs with Part Number/REF Number 0146-00-0097 and with Serial Numbers matching those listed at the top of the "Urgent Medical Device Removal" letter. Replace any affected battery with an unaffected battery and remove affected product from areas of use. Forward this information to all current and potential Cardiosave Hybrid and Cardiosave Rescue IABP users within your hospital or facility.  Whether you have affected product or not, please complete and sign the URGENT MEDICAL DEVICE REMOVAL – RESPONSE FORM attached to the "Urgent Medical Device Removal" letter to acknowledge that you have received this notification and disposed properly of the affected product. Health professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program: Complete and submit the report online. Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on form, or submit by fax to 1-800-FDA-0178.

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