Recall Z-1681-2015 ยท LKK Pump, Infusion, Implanted, Programmable
Medtronic Neuromodulation
Medtronic SynchroMed II Implantable Infusion Pumps, models 8637-20 and 8637-40. Sterile. Product Usage: 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 28, 2015 (initiated Apr 10, 2015) |
| Status | Terminated |
| Reason | Medtronic is conducting a recall of a specific subset of Model 8637-20 and 8637-40 SynchroMed II implantable drug pumps because the audible alarm could cease to function. |
| Root cause | Process control |
| Action | Customers were sent a Medtronic "Urgent Medical Device Removal" letter dated April 2015. The letter described the problem and the product involved in the recall. The letter described the "Required Actions" which included to quarantine and return the product, complete and return the Customer Confirmation Form, and to share the notification with other customers. For questions, they can contact Medtronic Neuromodulation Technical Services at 1-800-707-0933. A second letter was sent to Healthcare Professional. The "Urgent Medical Device Correction" letter dated April 2015 described the Nature of |
| Quantity | 1901 (1576 US, 325 OUS) |
| Distribution | Worldwide Distribution - US Nationwide including DC AND PR and in the countries of : Argentina, Austria, Belgium, France, Germany, Ireland, Italy, Japan, Luxembourg, Malta, Netherlands, Norway, Panama, Poland, Portugal, Russian Federation, San Marino, Saudi Arabia, South Korea, Spain, Switzerland |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.