Recall Z-1966-2019— Datascope Corporation

Name: FDA recall Z-1966-2019
Creator: U.S. Food and Drug Administration
Published: 2019-05-28

Class II · Terminated

Class II FDA medical device recall by Datascope Corporation, initiated 2019-05-28, terminated 2023-09-25. It names one FDA 510(k) clearance: K122628. Product: Sensation Plus 7.5Fr. 40cc Intra-Aortic Balloon Catheter with accessories, Part Number 0684-00-0568-01 Product Usage: The Sensation Plus 7.5Fr. 40cc Intra-Aortic Balloon Catheter with accessories is a device that includes a catheter, an insertion kit and two STATLOCK IAB stabilization devices. It is a cardiac assist device intended to provide counterpulsation 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 device was distributed with the outer carton labeled with the manufacture date and the expiry date reversed. This showed the product as expired before it was manufactured..

Recalling firm: Datascope Corporation
Classification: Class II
Status: Terminated
Initiated: 2019-05-28
Terminated: 2023-09-25
Firm location: Fairfield, NJ, United States

510(k) clearances named in this recall

1 on FDA's record

K122628 — SENSATION PLUS 7.5FR. 40CC INTRA-AORTIC BALLOON (IAB) CATHETER AND ACCESSORIESDatascope Corp., Cardiac Assist Division·cleared 2012-09-06

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

Sensation Plus 7.5Fr. 40cc Intra-Aortic Balloon Catheter with accessories, Part Number 0684-00-0568-01 Product Usage: The Sensation Plus 7.5Fr. 40cc Intra-Aortic Balloon Catheter with accessories is a device that includes a catheter, an insertion kit and two STATLOCK IAB stabilization devices. It is a cardiac assist device intended to provide counterpulsation 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 device was distributed with the outer carton labeled with the manufacture date and the expiry date reversed. This showed the product as expired before it was manufactured.

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