Recall Z-0335-2011 ยท LKK Pump, Infusion, Implanted, Programmable
Medtronic, Inc. - Neuromodulation
Medtronic Intrathecal Catheter Spinal Segment Revision Kit, 8598A. Method of Sterilization: Ethylene Oxide. Manufacturer Medtronic, Inc., 710 Medtronic Parkway, Minneapolis, MN 55432-5604 USA. The Medtronic Model 8598A Spinal Segment Revision Kit is used when a revision to the spinal segment of a Model 8731 or Model 8731SC catheter is required. The catheter is part of an infusion system tha
| Date | Nov 9, 2010 (initiated Sep 29, 2010) |
| Status | Terminated |
| Reason | Medtronic is recalling specific lots of Model 8731SC intrathecal catheter kits and Model 8598A intrathecal catheter spinal revision kits because there is the potential that the 11.4 cm introducer needles within these kits may exceed USP requirements for bacterial endotoxin. |
| Root cause | Material/Component Contamination |
| Action | Medtronica sent an "Urgent: Medical Device Recall" letter, dated September 2010, was sent to medical facilities/customers beginning September 29, 2010. The letter described the issue, identified affected product, requested that unused inventory be segregated and returned to Medtronic Neuromodulation per the enclosed Product Return Instructions form. A Recall Reply Card was also asked to be returned. Additionally an "Urgent: Medical Device Recall" letter was addressed to Healthcare Providers/customers to inform them of the recall of the Catheter and Revision Kits, identified patients by mean |
| Quantity | 420 |
| Distribution | AL, CA, CO, CT, FL, GA, HI, ID. IL, IN, KS, KY, MA, MD, MI, MN, MO, MT, NC, NJ, NM, NY, OH, OR, PA, SC, SD, TN, TX, VA, WA, WI, WV, WY. OUS to include: Argentina, Austria, Belgium, Canada, Chile, Czech Republic, France, Germany, Greece, Hungary, Ireland, Israel, Italy, San Marino, Jordan, Lithuan |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.