Recall Z-1055-2016 ยท DSP System, Balloon, Intra-Aortic And Control
Arrow International, Inc., Division of Teleflex Medical Inc.
FiberOptix Ultra 8 IAB: 8Fr 30cc The Arrow IAB is utilized for intra aortic balloon counterpulsation therapy in the aorta, whereby balloon inflation, during diastole and deflation, during systole increases blood supply to the heart muscle and decreases work of the left ventricle.
| Date | Mar 11, 2016 (initiated Feb 10, 2016) |
| Status | Terminated |
| Reason | The sheath body may become separated from the sheath hub. If the separation occurs, there is a potential for bleeding from the device. |
| Root cause | Process control |
| Action | The firm, Teleflex Arrow International, sent an "Urgent Medical Device Recall Notification" letter dated 2/11/2016 via FedEx to its Customers. The letter described the product, problem and actions to be taken. The customers were informed of the reason for recall and were instructed to take the following actions: 1. If you have any products referenced in the attached enclosure, immediately discontinue use and quarantine those products appropriately. 2. To return product, complete the enclosed Recall Acknowledgement Form and fax it to 1-855-419-8507 Attn: Customer Service or email it to recalls@ |
| Quantity | 13,405 US and 33,735 OUS in total |
| Distribution | Worldwide Distribution: US (Nationwide) and countries of: Argentina, Australia, Belgium, Brunei Darussalam, Brazil, Bahamas, Canada, Chile, China, Colombia, Ecuador, Guatemala, Hong Kong, Indonesia, India, Japan, Korea (Republic of [South] Korea), Myanmar, Mexico, Malaysia, Nepal, New Zealand, Panam |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K021462 | ARROW INTRA-AORTIC BALLOON (IAB) CATHETER WITH A FIBER OPTIC SENSOR AND A MEASUREMENT SYSTEM, MODELS IAB-05830-F,IAB5840 Arrow Intl., Inc., Jun 6, 2002 |