Recall Z-0525-2015 ยท DQY Catheter, Percutaneous
Concentric Medical Inc
Distal Access Catheter: Model Numbers: 90121, 90130, 90131, 90160. The Distal Access Catheter is intended for use in facilitating the insertion and guidance of an occlusion catheter, infusion catheter or other appropriate microcatheter into a selected blood vessel in the peripheral, coronary and neuro vascular systems.
| Date | Dec 12, 2014 (initiated Sep 26, 2013) |
| Status | Terminated |
| Reason | Distal Access Catheters were shipped to US customers with the Directions for Use that included instructions for aspiration. This version of the DFU is only approved outside of the US. |
| Root cause | Labeling mix-ups |
| Action | The firm, Concentric Medical, sent an "URGENT MEDICAL DEVICE RECALL NOTIFICATION" letter dated September 26, 2013 consignees/customers at all affected sites by registered mail. The letter described the product, problem and actions to be taken. The consignees/customers were instructed to immediately locate the subject devices and quarantine them; distribute notice to all affected departments in your facility; inform Concentric Medical (Stryker Neuovascular) if any of the subject devices have been distributed to other organizations; complete, sign and return the attached Customer Response Form v |
| Quantity | 87 units |
| Distribution | US Distribution to states of: TX, TN, PA, MI, VA, CA, NC, MS, FL, IL, MA, AZ, OK, NY, KY, WA, and AL. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K110483 | MODIFIED HD GUIDE CATHETER Concentric Medical, Inc., Apr 4, 2011 |