Intra-Aortic Balloon Catheter Mega 7.5FR 30cc Product Usage: The intra-aortic balloon catheter and accessories are used
FDA device recall Z-1384-2018 · posted 2018-04-16 · Terminated
Recall details
- Recalling firm
- Datascope Corporation
- Reason for recall
- The U.S. Instructions For Use for the Mega Intra-Aortic Balloon (IAB) Catheter was missing the Contraindications section.
- 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.
- Root cause
- Error in labeling
- Status
- Terminated
- Product code
- DSP
- Quantity affected
- 655
- Distribution
- US Nationwide Distribution
- Date initiated
- 2018-02-21
- Date posted
- 2018-04-16
- Date terminated
- 2020-03-18
- Location
- Fairfield, NJ
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| MEGA(TM) 7.5FR. 30CC INTRA-AORTIC BALLOON CATHETER AND ACCESSORIES, MEGA(TM) 7.5FR. 40CC INTRA-AORTIC BALLOON CATHETER (K120868) | Datascope Corp., Cardiac Assist Division | 2012-04-20 |