Recall Z-1386-2017— Maquet Datascope Corp - Cardiac Assist Division
Class II · Terminated
Class II FDA medical device recall by Maquet Datascope Corp - Cardiac Assist Division, initiated 2016-12-23, terminated 2019-03-01. It names 2 FDA 510(k) clearances: K151254, K112372. Product: CARDIOSAVE Hybrid IABP and CARDIOSAVE Rescue IABP affected part number is 0998-:XX-0800-XX Li-Ion Battery affected part number is 0146-00-0097 Product Usage: The CARDIOSAVE Hybrid Intra-Aortic Balloon Pump (IABP) is an electromechanical system used to inflate and deflate intra-aortic balloons. Reason: Maquet has received 3 confirmed complaints related to the Li-lon Battery used with the Maquet CARDIOSAVE Hybrid IABP and Maquet CARDIOSAVE Rescue IABP of the battery venting after being accidentally dropped..
- Recalling firm
- Maquet Datascope Corp - Cardiac Assist Division
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2016-12-23
- Terminated
- 2019-03-01
- Firm location
- Mahwah, NJ, United States
510(k) clearances named in this recall
2 on FDA's record- K151254 — CARDIOSAVE Hybrid Intra-Aortic Balloon Pump
- K112372 — CARDIOSAVE HYBRID INTRA-AORTIC BALLOON PUMP
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 Hybrid IABP and CARDIOSAVE Rescue IABP affected part number is 0998-:XX-0800-XX Li-Ion Battery affected part number is 0146-00-0097 Product Usage: The CARDIOSAVE Hybrid Intra-Aortic Balloon Pump (IABP) is an electromechanical system used to inflate and deflate intra-aortic balloons
Reason for recall
Maquet has received 3 confirmed complaints related to the Li-lon Battery used with the Maquet CARDIOSAVE Hybrid IABP and Maquet CARDIOSAVE Rescue IABP of the battery venting after being accidentally dropped.
Data sourced from openFDA. This site is unofficial and independent of the FDA.