Recall Z-0864-2011 ยท DQY Catheter, Percutaneous
Medtronic CardioVascular
Pioneer Plus Catheter PPlus 120 dual lumen device, inserted through a 6F introducer sheath and placed percutaneously into a peripheral vessel. The device tracks to its intended site in the vasculature over a standard length, commercially available 0.014" (0.36 mm) Rapid Exchange (RX) tracking guide wire. It utilizes an extendable, hollow Nitinol guide tip (needle) to facilitate the redirection an
| Date | Jan 6, 2011 (initiated Apr 30, 2010) |
| Status | Terminated |
| Reason | Needles may fail to retract and thus cause injury. |
| Root cause | Nonconforming Material/Component |
| Action | Medtronic sent an Urgent Medical Device Safety Information letter to all affected customers. The letter identified the product, the problem,and the action to be taken by the customer. Sales Representatives were to contact each account and complete an acknowledgement form indicating the Physicians had been notified. For questions regarding this recall customers were to contact their local representative. |
| Quantity | 1,080 units |
| Distribution | Worldwide Distribution - USA, Germany, Netherlands, Slovakia, and Spain |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K081804 | PIONEER PLUS CATHETER Medtronic, Inc., Aug 5, 2008 |