Recall Z-1944-2019— Datascope Corp.

Name: FDA recall Z-1944-2019
Creator: U.S. Food and Drug Administration
Published: 2019-06-17

Class I · Ongoing

Class I FDA medical device recall by Datascope Corp., initiated 2019-06-17. It names one FDA 510(k) clearance: K151254. Product: CS300 Intra-Aortic Balloon Pump, English, 220V; 0998-00-3023-55 For cardiovascular use.. Reason: If battery maintenance is not performed per instructions, the battery may provide less than the minimum run time of operating power..

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

1 on FDA's record

K151254 — CARDIOSAVE Hybrid Intra-Aortic Balloon PumpDatascope Corp.·cleared 2015-07-02

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 Intra-Aortic Balloon Pump, English, 220V; 0998-00-3023-55 For cardiovascular use.

Reason for recall

If battery maintenance is not performed per instructions, the battery may provide less than the minimum run time of operating power.

Data sourced from openFDA. This site is unofficial and independent of the FDA.