Recall Z-1928-2018— Maquet Datascope Corp - Cardiac Assist Division
Class I · Ongoing
Class I FDA medical device recall by Maquet Datascope Corp - Cardiac Assist Division, initiated 2018-05-03. It names 2 FDA 510(k) clearances: K151254, K112372. Product: CARDIOSAVE Hybrid Intra-Aortic Balloon Pump (IABP), Part Number 0998-00-0800-XX & 0998-UC-0800-XX (excluding 0998-00-0800-83, 0998-UC-0800-83 & 0998-00-0800-75) and cart 0997-00-1179. Reason: Ingress of fluids into the device can affect various electronic circuit boards which would prevent initiation or continuation of therapy..
- Recalling firm
- Maquet Datascope Corp - Cardiac Assist Division
- Classification
- Class I
- Status
- Ongoing
- Initiated
- 2018-05-03
- 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 Intra-Aortic Balloon Pump (IABP), Part Number 0998-00-0800-XX & 0998-UC-0800-XX (excluding 0998-00-0800-83, 0998-UC-0800-83 & 0998-00-0800-75) and cart 0997-00-1179
Reason for recall
Ingress of fluids into the device can affect various electronic circuit boards which would prevent initiation or continuation of therapy.
Data sourced from openFDA. This site is unofficial and independent of the FDA.