Recall Z-0205-2015 ยท DQY Catheter, Percutaneous
Medtronic Vascular
Medtronic Launcher Coronary Guide Catheter; MODEL: LA6JR40K
| Date | Nov 13, 2014 (initiated Oct 13, 2014) |
| Status | Terminated |
| Reason | Two reports have been received on the 6F launcher Guide Catheter lot (Model Number LA6JR40K; lot No 0007244836} for incorrect usable length of the Guide Catheter. It was reported that the catheters had a usable length of 90 cm instead of 55 cm, which was specified on the packaging label. Usable length is defined as the total length of catheter shaft from the distal end of the strain relief to the |
| Root cause | Process control |
| Action | Beginning October 13, 2014, Medtronic field representatives will being hand delivery of the customer communication to affected customers, notifying them of the issue, and requesting return of unaffected product. Customers will be asked to sign a certificate confirming they have received the notification and have taken the requested action. 1. Identify and quarantine all listed, unused product in your inventory. 2. Return all listed product in your inventory to Medtronic. Contact Customer Service at 888-283-7868 to initiate a product return and credit. Your Medtronic sales representative can |
| Quantity | 11 devices |
| Distribution | US Distribution including the states of NC, IA, IL and KS. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K021256 | Z3 GUIDE CATHETER Medtronic Vascular, May 17, 2002 |