Recall Z-1385-2018
Datascope Corporation · initiated February 21, 2018
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Intra-Aortic Balloon Catheter Mega 8FR 50cc Product Usage: The intra-aortic balloon catheter and accessories are used to provide counter pulsation therapy in the aorta, whereby balloon inflation during diastole and deflation during systole increases blood supply to the heart muscle and decreases the work of the left ventricle.
Codes / lots: 0684 00 0296 01U and 0684 00 0296 02U
Reason for recall
The U.S. Instructions For Use for the Mega Intra-Aortic Balloon (IAB) Catheter was missing the Contraindications section.
FDA-determined cause: Error in labeling
Action taken
Maquet/Getinge issued a recall letter on February 21, 2018 to affected customers, via FEDEX with confirmation of delivery, to notify them of the fact that the IFU is missing the Contraindications section and to provide the missing information. Affected customers are instructed to examine their inventory immediately to determine if they have affected product. An Addendum to the Mega IAB Catheter IFU, containing the Contraindications, is provided as an attachment in the recall letter. It is suggested that affected customers post copies of the Addendum near all affected lot numbers of Mega IAB Catheters. Customers are provided with Maquet/Getinge contact information should their facility require a full copy of the correct Mega IAB Catheter IFU. Lastly, affected customers are instructed to complete and sign a response form, acknowledging that they have received the notification, and return the form to Maquet/Getinge.
Details
- Recall number
- Z-1385-2018
- Initiated
- February 21, 2018
- Posted by FDA
- April 16, 2018
- Terminated
- March 18, 2020
- Product code
- DSP – System, Balloon, Intra-Aortic And Control
- Quantity
- 12744
- Distribution
- US Nationwide Distribution
- Recalling firm
- Datascope Corporation, Fairfield, NJ
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-1383-2018 Class II | Intra-Aortic Balloon Catheter Mega 7.5FR 40cc Product Usage: The intra-aortic balloon…The U.S. Instructions For Use for the Mega Intra-Aortic Balloon (IAB) Catheter was missing the… | 02/21/2018Terminated |
| Z-1384-2018 Class II | Intra-Aortic Balloon Catheter Mega 7.5FR 30cc Product Usage: The intra-aortic balloon…The U.S. Instructions For Use for the Mega Intra-Aortic Balloon (IAB) Catheter was missing the… | 02/21/2018Terminated |