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.
- Cardiosave Hybrid/Rescue Intra-Aortic Balloon Pump Battery Packs
- Product Codes and Lot Numbers: See Recall Database Entry
- Devices Recalled in the United States: 137 battery packs
- Distribution Date: September 23, 2017 to August 17, 2021
- Date Initiated by Firm: September 21, 2021
The CardioSave Hybrid/Rescue Intra-Aortic Balloon Pumps (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.
Figure 1: Cardiosave HYBRID Intra-Aortic Balloon Pump
Figure 2: Cardiosave RESCUE Intra-Aortic Balloon Pump
Reason for Recall
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.
Who May Be Affected
- Health care providers using the affected Cardiosave Hybrid/Rescue Intra-Aortic Balloon Pump
- Patients receiving circulatory support with the affected Cardiosave Hybrid/Rescue Intra-Aortic Balloon Pump
What to Do
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.
- Should you have the affected product, you are eligible for credit or a replacement at no cost to the facility upon receipt of the Response Form attached to the “Urgent Medical Device Removal" letter (see page 4).
- To get the free replacement battery, provide your shipping information and your acknowledgment on page 4 that the defective battery will be disposed once you receive the replacement battery pack.
- Dispose of affected batteries properly in accordance with local statutes and the labeling on the battery pack. (See Figure 1 in the “Urgent Medical Device Removal" letter)
- Forward this information to all current and potential Cardiosave Hybrid and Cardiosave Rescue IABP users within your hospital or facility.
- If you are a distributor who has shipped any affected products to customers, please forward this document to their attention for appropriate action.
- 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 (page 4) to acknowledge that you have received this notification and disposed properly of the affected product.
- Return the completed form to Datascope/Getinge/Maquet by e-mailing a scanned copy to Li-Ionbattery.Datascope@getinge.com or by FAX to (877)-446-3360.
Customers who have questions about this recall should contact their Datascope/Getinge/Maquet Sales Representative or, for technical questions, contact Customer Service (1-888-943-8872, option 2), Monday through Friday, between the hours of 8:00 a.m. and 6:00 p.m. EST.
How do I report a problem?
Health care professionals and consumers may report adverse reactions or quality problems they experienced using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program using an online form, regular mail, or FAX.