Recall Z-1942-2019— Datascope Corp.
Class I · Ongoing
Class I FDA medical device recall by Datascope Corp., initiated 2019-06-17. It names 4 FDA 510(k) clearances: K181122, K163542, K151254 and 1 more. Product: CS100 Intra-Aortic Balloon Pump, English, 220V; 0998-00-3013-55 For cardiovascular use.. Reason: If battery maintenance is not performed appropriately, the battery may provide less than the minimum run time of operating power. Revised labeling and training are being provided..
- Recalling firm
- Datascope Corp.
- Classification
- Class I
- Status
- Ongoing
- Initiated
- 2019-06-17
- Firm location
- Mahwah, NJ, United States
510(k) clearances named in this recall
4 on FDA's record- K181122 — CARDIOSAVE Intra-Aortic Balloon Pump
- 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
CS100 Intra-Aortic Balloon Pump, English, 220V; 0998-00-3013-55 For cardiovascular use.
Reason for recall
If battery maintenance is not performed appropriately, the battery may provide less than the minimum run time of operating power. Revised labeling and training are being provided.
Data sourced from openFDA. This site is unofficial and independent of the FDA.