Recall Z-1384-2018— Datascope Corporation

Name: FDA recall Z-1384-2018
Creator: U.S. Food and Drug Administration
Published: 2018-02-21

Class II · Terminated

Class II FDA medical device recall by Datascope Corporation, initiated 2018-02-21, terminated 2020-03-18. It names one FDA 510(k) clearance: K120868. Product: Intra-Aortic Balloon Catheter Mega 7.5FR 30cc Product Usage: The intra-aortic balloon catheter and accessories are used to provide counter pulsation therapy in the aorta, whereby balloon inflation during diastole and deflation during systole increases blood supply to the heart muscle and decreases the work of the left ventricle.. Reason: The U.S. Instructions For Use for the Mega Intra-Aortic Balloon (IAB) Catheter was missing the Contraindications section..

Recalling firm: Datascope Corporation
Classification: Class II
Status: Terminated
Initiated: 2018-02-21
Terminated: 2020-03-18
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

Intra-Aortic Balloon Catheter Mega 7.5FR 30cc Product Usage: The intra-aortic balloon catheter and accessories are used to provide counter pulsation therapy in the aorta, whereby balloon inflation during diastole and deflation during systole increases blood supply to the heart muscle and decreases the work of the left ventricle.

Reason for recall

The U.S. Instructions For Use for the Mega Intra-Aortic Balloon (IAB) Catheter was missing the Contraindications section.

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