Recall Z-1523-2014— Maquet Datascope Corp - Cardiac Assist Division
Class I · Terminated
Class I FDA medical device recall by Maquet Datascope Corp - Cardiac Assist Division, initiated 2014-03-21, terminated 2018-03-20. It names 3 FDA 510(k) clearances: K063525, K031636, K965236. Product: 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.. 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..
- Recalling firm
- Maquet Datascope Corp - Cardiac Assist Division
- Classification
- Class I
- Status
- Terminated
- Initiated
- 2014-03-21
- Terminated
- 2018-03-20
- Firm location
- Mahwah, NJ, United States
510(k) clearances named in this recall
3 on FDA's record- K063525 — DATASCOPE FIBER OPTIC PRESSURE SENSOR INTRA-AORTIC BALLOON CATHETER AND CS300 INTRA-AORTIC BALLOON PUMP CONTROL SYSTEM
- K031636 — CS100 INTRA-AORTIC BALLOON PUMP, MODEL 0998-00-3013-XX
- K965236 — SYSTEM 96 INTRA-AORTIC BALLOON PUMP (IABP)
K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
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.
Reason for recall
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.