Recall Z-1062-2015— Maquet Datascope Corp - Cardiac Assist Division
Class II · Terminated
Class II FDA medical device recall by Maquet Datascope Corp - Cardiac Assist Division, initiated 2014-12-16, terminated 2017-06-09. It names 2 FDA 510(k) clearances: K112372, K063525. Product: CARDIOSAVE Intra-Aortic Balloon Pump and CS300 Intra-Aortic Balloon Pump; and, non-sterile, not for human use, SENSATION and SENSATION PLUS IABC demonstration units. Part Number 0998-00-0800-xx; 0998-00-3023-xx; 0998-UC-0800-xx; 0998-UC-3023-xx An electromechanical system used to inflate and deflate intra-aortic balloons.. Reason: Ferrule Cap was not removed on some fiber-optic Sensation and Sensation Plus IABC demonstration units. If fiber-optic connector is inserted into the Maquet CS300 or CARDIOSAVE IABP, cap will prevent connection of unit and may become dislodged and remain in IABPs fiber-optic receptacle..
- Recalling firm
- Maquet Datascope Corp - Cardiac Assist Division
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2014-12-16
- Terminated
- 2017-06-09
- Firm location
- Mahwah, NJ, United States
510(k) clearances named in this recall
2 on FDA's record- K112372 — CARDIOSAVE HYBRID INTRA-AORTIC BALLOON PUMP
- K063525 — DATASCOPE FIBER OPTIC PRESSURE SENSOR INTRA-AORTIC BALLOON CATHETER AND CS300 INTRA-AORTIC BALLOON PUMP CONTROL SYSTEM
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
CARDIOSAVE Intra-Aortic Balloon Pump and CS300 Intra-Aortic Balloon Pump; and, non-sterile, not for human use, SENSATION and SENSATION PLUS IABC demonstration units. Part Number 0998-00-0800-xx; 0998-00-3023-xx; 0998-UC-0800-xx; 0998-UC-3023-xx An electromechanical system used to inflate and deflate intra-aortic balloons.
Reason for recall
Ferrule Cap was not removed on some fiber-optic Sensation and Sensation Plus IABC demonstration units. If fiber-optic connector is inserted into the Maquet CS300 or CARDIOSAVE IABP, cap will prevent connection of unit and may become dislodged and remain in IABPs fiber-optic receptacle.
Data sourced from openFDA. This site is unofficial and independent of the FDA.