Recall Z-2182-2008 ยท LKK Pump, Infusion, Implanted, Programmable
Medtronic Neuromodulation
Medtronic Synchromed II Programmable Pump , Medtronic Inc., Minneapolis, MN 55432-5604 40 ml Pumps Model 8637-40 The implantable Medtronic SynchroMed II Programmable Pump is part of the SynchroMed II Infusion System designed to contain and administer prescribed drugs to a specific site. The implantable components of the SynchroMed II Infusion System include the pump, catheter, and catheter ac
| Date | Sep 3, 2008 (initiated May 1, 2008) |
| Status | Terminated |
| Reason | SynchroMed II pumps (non-implanted) may have been manufactured without propellant. |
| Root cause | Process control |
| Action | Consignees were contacted by "Medtronic Urgent: Medical Device Recall" letters dated May 2008. The SynchoMed II pumps may have been manufactured without propellant. This device is limited to non-implanted SynchoMedl II pumps. Physcians should not impant these potentially affected pumps. The notifcation provides information on how to identify Pumps Without Propellant, Patient Management Recommendations and Additional Resources. A separate letter was issued to Inventory/Risk Mangers. The letter described the product and problem and included a section on the Product Recall, Returning Prod |
| Quantity | 6047 |
| Distribution | AK, AL, AR, AZ, CA, DO, CT, DC, DE, FL, GA, HI, IA, ID, IL IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, HY, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, DS, TN, TX, UT, VA, VT, WA, WI, WV, WY, Australia, Canada ,Austria, Belgium, Cyprus, Russian Federation, Czech Republic, Denmark, Finla |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.