Recall Z-1523-2014 ยท DSP System, Balloon, Intra-Aortic And Control
Maquet Datascope Corp - Cardiac Assist Division
Datascope System 98/98xt, CS 100/CS100i and CS 300 Intra-Aortic Balloon Pump. The Intra-Aortic Balloon Pump (IABP) is an electromechanical system used to inflate and deflate intra-aortic balloons in cardiovascular procedures.
| Date | May 21, 2014 (initiated Mar 21, 2014) |
| Status | Terminated |
| Reason | Potential mechanical failure of the fan assembly associated with the power supply. A fan assembly failure could result in the power supply overheating and cause the IABP to shut down without warning. |
| Root cause | Nonconforming Material/Component |
| Action | Maquet Inc. sent an Urgent Medical Device Field Correction letter dated March 21, 2014, to all affected customers. The letter identified the affected product, problem, and actions to be taken.. Customers were instructed that their Service Representatiave would contact them to schedule the replacement of the fan assembly at no cost to the customer. Upon completion customers were requested to sign a service repair order to verify satisfactory completion of the work. Customers with questions within Puerto Rico, were instructed to contact Technical Support in Mexico at +52-55-9000-8970, ext 10 |
| Quantity | 11,881 units (US 5183 and OUS 6698) |
| Distribution | Worldwide Distribution - USA (nationwide) and approximately 104 countries. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K031636 | CS100 INTRA-AORTIC BALLOON PUMP, MODEL 0998-00-3013-XX Datascope Corp., Aug 11, 2003 |
| K063525 | DATASCOPE FIBER OPTIC PRESSURE SENSOR INTRA-AORTIC BALLOON CATHETER AND CS300 INTRA-AORTIC BALLOON PUMP CONTROL SYSTEM Datascope Corp., Jan 5, 2007 |
| K965236 | SYSTEM 96 INTRA-AORTIC BALLOON PUMP (IABP) Datascope Corp., Jul 1, 1997 |