Recall Z-0337-2022— Datascope Corp.
Class I · Ongoing
Class I FDA medical device recall by Datascope Corp., initiated 2021-11-15. It names 3 FDA 510(k) clearances: K163542, K151254, K112372. Product: Cardiosave Rescue IntraAortic Balloon Pump. Model Numbers: 0998-00-0800-75, 0998-UC-0800-75, 0998-00-0800-83, 0998-UC-0800-83, 0998-00-0800-85, 0998-UC-0800-85.. Reason: Firm is initiating a correction due to the possibility of fluid ingress. Fluid entering the device may short various electronic components thus leading to system shutdown, which could result in unsafe hemodynamic instability..
- Recalling firm
- Datascope Corp.
- Classification
- Class I
- Status
- Ongoing
- Initiated
- 2021-11-15
- Firm location
- Mahwah, NJ, United States
510(k) clearances named in this recall
3 on FDA's record- K163542 — CARDIOSAVE Hybrid and Rescue Intra-Aortic Balloon Pump, CARDIOSAVE Li-Ion Battery Transport and Storage Case
- 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 Rescue IntraAortic Balloon Pump. Model Numbers: 0998-00-0800-75, 0998-UC-0800-75, 0998-00-0800-83, 0998-UC-0800-83, 0998-00-0800-85, 0998-UC-0800-85.
Reason for recall
Firm is initiating a correction due to the possibility of fluid ingress. Fluid entering the device may short various electronic components thus leading to system shutdown, which could result in unsafe hemodynamic instability.
Data sourced from openFDA. This site is unofficial and independent of the FDA.