Recall Z-2833-2020— Datascope Corporation

Name: FDA recall Z-2833-2020
Creator: U.S. Food and Drug Administration
Published: 2020-07-27

Class II · Ongoing

Class II FDA medical device recall by Datascope Corporation, initiated 2020-07-27. It names one FDA 510(k) clearance: K120868. Product: Datascope Intra-Aortic Ballon Catheters (IABs)-MEGA 8Fr 50cc IAB Kit P/N: 0684-00-0296-01, 0684-00-0296-01U,0684-00-0296-02, 0684-00-0296-02U, 0684-00-0296-10; 0684-00-0498-01, 0684-00-0498-07, 0684-00-0498-08 Product Usage: Indications For Use: Acute Coronary Syndrome Cardiac and Non-Cardiac Surgery Complications of Heart Failure.. Reason: Potential Endotoxin Contamination.

Recalling firm: Datascope Corporation
Classification: Class II
Status: Ongoing
Initiated: 2020-07-27
Firm location: Fairfield, NJ, United States

510(k) clearances named in this recall

1 on FDA's record

K120868 — MEGA(TM) 7.5FR. 30CC INTRA-AORTIC BALLOON CATHETER AND ACCESSORIES, MEGA(TM) 7.5FR. 40CC INTRA-AORTIC BALLOON CATHETERDatascope Corp., Cardiac Assist Division·cleared 2012-04-20

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

Datascope Intra-Aortic Ballon Catheters (IABs)-MEGA 8Fr 50cc IAB Kit P/N: 0684-00-0296-01, 0684-00-0296-01U,0684-00-0296-02, 0684-00-0296-02U, 0684-00-0296-10; 0684-00-0498-01, 0684-00-0498-07, 0684-00-0498-08 Product Usage: Indications For Use: Acute Coronary Syndrome Cardiac and Non-Cardiac Surgery Complications of Heart Failure.

Reason for recall

Potential Endotoxin Contamination

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