Recall Z-1487-2026— Datascope Corp.
Class II · Ongoing
Class II FDA medical device recall by Datascope Corp., initiated 2026-01-23. It names 2 FDA 510(k) clearances: K172305, K063525. Product: CS300 IABP. Software Version CS300 IABP C.01.. Reason: The firm has identified that the battery runtime and cycle specifications contained in the devices Instructions for Use (IFU) need to be updated..
- Recalling firm
- Datascope Corp.
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2026-01-23
- Firm location
- Mahwah, NJ, United States
510(k) clearances named in this recall
2 on FDA's record- K172305 — CS100/CS100i Intra-Aortic Balloon Pump, CS300 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
CS300 IABP. Software Version CS300 IABP C.01.
Reason for recall
The firm has identified that the battery runtime and cycle specifications contained in the devices Instructions for Use (IFU) need to be updated.
Data sourced from openFDA. This site is unofficial and independent of the FDA.