Recall Z-1570-2014 ยท LKK Pump, Infusion, Implanted, Programmable
Medtronic Neuromodulation
Medtronic SynchroMed II Implantable Drug Infusion Pump, Model 8637-20, 8637-40. The implantable Medtronic SynchroMed II programmable pumps are part of an infusion system that stores and delivers a prescribed drug to a specific site. The implanted infusion system consists of a SynchroMed II pump and a catheter.
| Date | May 8, 2014 (initiated Feb 26, 2014) |
| Status | Terminated |
| Reason | This recall provides important new information regarding overinfusion associated with the Medtronic SynchroMed II Implantable Pump. Overinfusion can result in a life-threatening overdose and can also result in drug withdrawal due to premature emptying of the pump. Due to the low reported rate of occurrence of this issue and the inability to predict which pumps may be at risk, Medtronic is not re |
| Root cause | Under Investigation by firm |
| Action | Medtronic sent a "Urgent Medical Device Correction" letter dated March 2014. The letter was sent to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. The letter provided the Explanation of the Issue, Scope and Severity, Recommendations, and Important Guidelines. Customer visits were started by Medtronic field Representatives on February 26th, 2014. Medtronic is communicating this information to the appropriate regulatory agencies globally, including the U.S. Food and Drug Administration. We are committed to continui |
| Quantity | 195,198 pumps (146,435 US, 48,763 OUS) |
| Distribution | Worldwide Distribution - All states in USA. OUS: List not provided at this time. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.