Date Initiated by Firm | April 04, 2023 |
Date Posted | April 26, 2023 |
Recall Status1 |
Open3, Classified |
Recall Number | Z-1462-2023 |
Recall Event ID |
92021 |
510(K)Number | K112372 |
Product Classification |
System, balloon, intra-aortic and control - Product Code DSP
|
Product | MAQUET CARDIOSAVE hybrid Intra-Aortic Balloon Pump, Model Number 0998-XX-0800-32 |
Code Information |
UDI-DI: 10607567111117;
Serial Numbers: CB343612K1 CB351306D2 CB360094J2 CB351302D2 CB343613K1
CB359782J2 CB359780J2 CB320625E0 CH207880C5 CB359783J2
CB328500J0 CB356765G2 CB356763G2 CB314092J9 CB355433F2
CB355432F2 CB351305D2 CB311676I9 CB355435F2 CB319727D0
CB319726D0 CB342653J1 CB307113G9 CB360092J2 CH245699K6
CB307117G9 CB360095J2 CB351303D2 CB320623E0 CB320621E0
CB320620E0 CB311677I9 CB314093J9 CB356761G2
CB351307D2 CB329943K0 CB360093J2 CB307111G9
CB343611K1 CB307114G9 CB320624E0 CB351301D2
CB359781J2 CB351304D2 CB356762G2 CB355434F2
CB322068F0 CB342652J1 CB311675I9 CB320622E0
CB355431F2 CB314094J9 CB307112G9 CB307119G9 |
Recalling Firm/ Manufacturer |
Datascope Corp. 1300 Macarthur Blvd Mahwah NJ 07430-2052
|
For Additional Information Contact | Stephanie Moretti 973-709-7170 |
Manufacturer 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. |
FDA Determined Cause 2 | Component design/selection |
Action | 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. |
Quantity in Commerce | 54 units |
Distribution | International distribution in the country of Brazil. |
Total Product Life Cycle | TPLC Device Report |
|
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls. 2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall. 3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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510(K) Database | 510(K)s with Product Code = DSP
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