Recall Z-1935-2016 ยท DSP System, Balloon, Intra-Aortic And Control
Datascope Corporation
MEGA 7.5Fr. 30cc Intra-Aortic Balloon Catheter with Insertion Kit & STATLOCK MEGA 7.5Fr. 40cc Intra-Aortic Balloon Catheter with Insertion Kit & STATLOCK MEGA 8Fr. 50cc Intra-Aortic Balloon Catheter with Insertion Kit & STATLOCK MEGA 8Fr. 50cc Intra-Aortic Balloon Catheter with Insertion Kit, STATLOCK & APA
| Date | May 13, 2016 |
| Status | Terminated |
| Reason | It was discovered during post-quarantine packaging on 2/16/2016 that the IFU for the STATLOCK Sheath Stabilization device for Percutaneous Sheath Introducer (Vendor PN 2403097-1405R) was erroneously packaged with the Mega and Sensation Plus IAB Catheter Kits instead of the IFU for the STATLOCK Catheter Stabilization device for IAB catheters (Vendor PN 24030905-1406R). |
| Root cause | Unknown/Undetermined by firm |
| Action | Maquet Inc sent an Urgent Medical Device Field Correction Letter/Response Form dated 5/13/2016 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers. |
| Quantity | 31,030 units (US); 15,604 units (OUS) |
| Distribution | Worldwide Distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K120868 | MEGA(TM) 7.5FR. 30CC INTRA-AORTIC BALLOON CATHETER AND ACCESSORIES, MEGA(TM) 7.5FR. 40CC INTRA-AORTIC BALLOON CATHETER Datascope Corp., Cardiac Assist Division, Apr 20, 2012 |