Medtronic Intrathecal Catheter Spinal Segment Revision Kit, 8598A. Method of Sterilization: Ethylene Oxide. Manufacturer

FDA device recall Z-0335-2011 · posted 2010-11-09 · Terminated

Recall details

Recalling firm

Medtronic, Inc. - Neuromodulation

Reason for recall

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.

Action taken

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 means of registration information, Informed them of the issue with the needle inside the kits, and requested they stop using the specific lots and to monitor any patients for symptoms. If you have any questions or comments, please contact Medtronic Neuromodulation Technical Services at 1-800-707-0933.

Root cause

Material/Component Contamination

Status

Terminated

Product code

LKK

Quantity affected

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, Czec

Date initiated

2010-09-29

Date posted

2010-11-09

Date terminated

2011-12-10

Location

Minneapolis, MN