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Terminated

Medtronic Intrathecal Catheter, 8731SC with sutureless connector. Method of Sterilization: Ethylene Oxide. Manufacturer Medtronic, Inc., 710 Medtronic Parkway, Minneapolis, MN 55432-5604 The implantable Medtronic Model 8731SC intrathecal catheter is part of an infusion system that stores and delivers parenteral drugs to the intrathecal space. The implanted infusion system components consist of a Medtronic pump and a Model 8731SC catheter. The catheter connects to the pump at the catheter port. To deliver parenteral drugs to the intrathecal space. The needle is used to facilitate the placement of the catheter. The needle is inserted percutaneously into the intrathecal. The needle stylet is then removed to confirm the needle placement through observing backflow of cerebrospinal fluid (CSF) through the needle. The needle stylet prevents tissue coring and also minimizes loss of CSF. The spinal segment tip of the catheter is inserted through the needle until the catheter is advanced to the desired location. Once the catheter position is verified through fluoroscopy, the needle is carefully removed and discarded.

FDA Recall Z-0334-2011 · Posted 2010-11-09

Recalling FirmMedtronic, Inc. - Neuromodulation
Recall StatusTerminated
Product CodeLKK
Date Initiated2010-09-29
Date Terminated2011-12-10
Product Quantity1323

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.

Firm 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 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

Distribution Pattern

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, Lithuania, Netherlands, Norway, Saudi Arabia, Slovenia, South Africa, Spain, Sweden, Switzerland, Tunisia, United Arab Emirates, United Kingdom.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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