Recall Z-1966-2019 ยท DSP System, Balloon, Intra-Aortic And Control
Datascope Corporation
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
| Date | May 28, 2019 |
| Status | Terminated |
| 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. |
| Root cause | Employee error |
| 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. |
| Quantity | 471 |
| Distribution | 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, |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K122628 | SENSATION PLUS 7.5FR. 40CC INTRA-AORTIC BALLOON (IAB) CATHETER AND ACCESSORIES Datascope Corp., Cardiac Assist Division, Sep 6, 2012 |