Recall Z-2414-2011 ยท FMZ Incubator, Neonatal
Maquet Datascope Corp - Cardiac Assist Division
Datascope/ Maquet IABPs. System 98/98XT Intra-Aortic Balloon Pump; CS100/CS100i Intra-Aortic Balloon Pump; CS300 Intra-Aortic Balloon Pump; Manufactured by Datascope Corp., 1300 MacArthur Blvd., Mahwah, NJ 07430 The Intra-Aortic Balloon Pump (IABP) is an electromechanical system used to inflate and deflate intra-aortic balloon. It provides temporary support to the left ventricle via the princ
| Date | Jun 13, 2011 (initiated Mar 16, 2011) |
| Status | Terminated |
| Reason | Several models of the Intra-Aortic Balloon Pumps are being recalled due to a potential problem with the fan's assembly which may cause the power supply to detect an overheating event and shut down. |
| Root cause | Device Design |
| Action | Maquet sent an Urgent Product Field Correction letter dated March 16, 2011, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to note the WARNING in the IABP Operating Instruction. Customers were advised to refer to the IAB Instructions for Use, Section D (Manually inflating and Deflating a Catheter). Section D of the IAB instruction for Use reiterates that an IAB should not remain inactive for more than 30 minutes and also provides detailed instruction on how to keep an IAB active during IABP f |
| Quantity | 885 units |
| Distribution | Worldwide Distribution |
| 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 |