MAQUET CARDIOSAVE hybrid Intra-Aortic Balloon Pump, Model Number 0998-XX-0800-32

FDA device recall Z-1462-2023 · posted 2023-04-26 · Open, Classified

Recall details

Recalling firm

Datascope Corp.

Reason for recall

The power cord supplied (Type J plug end) for the Cardiosave Hybrid IABP to Brazil is incompatible with the Brazilian Type N power receptacle.

Action taken

An URGENT FIELD SAFETY NOTICE MEDICAL DEVICE CORRECTION was sent to customers beginning 4/4/23. Actions to be taken by the Customer now: Our records indicate that that you have received one or more CARDIOSAVE hybrid IABPs having the serial numbers that are affected by this recall. 1. Inspect the IABP to determine if it has a Type J power plug (refer to Image 1 below). If present, the IABP should not be used until the cord reel has been replaced. 2. Schedule a service appointment with your Datascope Corp./Getinge Service Representative for the cord reel correction from a Type J connector to Type N (refer to Image 2 below). 3. Please ensure that all Cardiosave Intra-Aortic Balloon Pump users at your hospital / facility are aware of this notice. 4. Please forward this information to all current and potential Cardiosave Hybrid IABP users within your hospital/facility. 5. If you are a distributor who has shipped any affected products to customers, please forward this letter to their attention for appropriate action. Actions to be taken: Please examine your inventory to determine you have a Cardiosave Hybrid IABP. Whether you have an affected cord or not, please complete and sign the attached RESPONSE FORM (Page 4) to acknowledge that you have received this notification. Actions to be taken by Getinge: Getinge will update the affected Cardiosave Hybrid IABPs that contain a Type J connector with a Type N connector to correct and address this issue. This voluntary correction notification only affects the products listed on page 1; no other products are affected by this voluntary correction. We apologize for any inconvenience this Medical Device Correction may cause. If you have any questions, please contact your Datascope/Getinge representative or call the Datascope Corp./Getinge Representative or office.

Root cause

Component design/selection

Status

Open, Classified

Product code

DSP

Quantity affected

54 units

Distribution

International distribution in the country of Brazil.

Date initiated

2023-04-04

Date posted

2023-04-26

Location

Mahwah, NJ

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