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Terminated

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.

FDA Recall Z-1966-2019 · Posted None

Recalling FirmDatascope Corporation
Recall StatusTerminated
Product CodeDSP
Date Initiated2019-05-28
Date Terminated2023-09-25
Product Quantity471

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.

Firm Action

An Urgent Medical Device Recall notification letters dated 5/28/19 was sent to the customer. The letter identified the affected product, problem and actions to be taken. Customers were instructed to complete the attached URGENT MEDICAL DEVICE RECALL CUSTOMER RESPONSE FORM on page 3, to acknowledge that you have received the Sensation Plus 7.5 Fr. 40cc Intra-Aortic Balloon Catheter with Accessories URGENT MEDICAL DEVICE RECALL. Please fax or email the completed Customer Response Form to 1-585-486-5605.

Root Cause

Employee error

Distribution Pattern

The products were distributed to the following US states: FL. The products were distributed to the following foreign countries: Australia, Austria, Belgium, Estonia, France, Germany, Ireland, Italy, Kuwait, Lithuania, Malaysia, Mexico, Netherlands, Poland, Russia, Saudi Arabia, Slovakia, Sweden, Switzerland, United Kingdom, Ukraine.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K122628SENSATION PLUS 7.5FR. 40CC INTRA-AORTIC BALLOON (IAB) CATHETER AND ACCESSORIESDatascope Corp., Cardiac Assist Division · 2012-09-06

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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