Recall Z-2754-2011 ยท DQY Catheter, Percutaneous
Medtronic Vascular
Medtronic 6F Zuma Guide Catheter with AL 1.5 Curve with side holes Catalog Number: Z26AL15SH The Medtronic Guiding Catheter is designed to provide a pathway through which therapeutic devices are introduced. The guiding catheter is intended to be used in the coronary or peripheral vascular system.
| Date | Jun 8, 2011 |
| Status | Terminated |
| Reason | Mislabeled; Product labeled as 6F Zuma Guide with AL 1.5 curve with side holes may contain a 5F Zuma Catheter with SAL 1.0 curve |
| Root cause | Labeling Change Control |
| Action | The firm, Medtronic, sent an "Urgent Medical Device Recall Notice(for US)" letter dated June 7, 2011 to its customers. The letter described the product, problem and actions to be taken. The customers were instructed to segregate the product so that it will not be used. A Medtronic Sales Representative will visit the customers to account for all units they received and initiate a credit as appropriate. If you have any questions, please call (978) 739-0371 or (978) 739-3259. |
| Quantity | 5 units |
| Distribution | Nationwide distribution: USA including states of: CA, FL, and MA. |
| FDA record | Open on fda.gov |