Events

Recall of Medtronic Intrathecal Catheter Spinal Segment Revision Kit, 8598A.

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Medtronic, Inc. - Neuromodulation.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    57024
  • Event Risk Class
    Class 2
  • Event Number
    Z-0335-2011
  • Event Date Posted
    2010-11-09
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-12-10
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=95196
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Pump, infusion, implanted, programmable - Product Code LKK
  • 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.
  • 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.

Device

Medtronic Intrathecal Catheter Spinal Segment Revision Kit, 8598A.
  • Model / Serial
    Lot No.: 0203951576, 0203961984, 0203967623, 0203968380, 0203972121, 0203975643, 0203975644, 0203977013, 0203986903, 0203986904, 0203986905, 0203986906, 0203986907, 0203986908, 0203987226, 0203987613, 0203987614, 0203987927, 0203992275, 0203994418, 0204000009, 0204008277, 0204013891, 0204013892, 0204013893, 0204021022, 0204025158, 0204032708, 0204036999, 0204077467, 0204086950, 0204086951, 0204086952, 0204086953, 0204093420, 0204100469, 0204100472, 0204106116, 0204127318, 0204128817, 0204133515, 0204133516, 0204133517, 0204133545, 0204133546, 0204133547, 0204135762, 0204135763, 0204150859, 0204151516, 0204151517, 0204152813, 0204153722, 0204164696, 0204168597, N258157001, N258157002, N258157003, N258157004, N258157005, N258158001, N258158002, N258158003, N258158004, N258158005, N258158006, N258158007, N258158008, N258158009, N258158010, N258158011, N258158012, N258158013, N258158014, N258158015, N258162001, N258162002, N258162003, N258162004, N258162005, N258162006, N258162007, N258162008, N258162009, N258162010, N258163001, N258163002, N258163003, N258163004, N258163005, N258320001, N258320002, N258320003, N258320004, N258320005, N258327001, N258327002, N258327003, N258327004, N258327005, N258327006, N258327007, N258327008, N258327009, N258327010, N258327011, N258327012, N258327013, N258327014, N258327015, N258329001, N258329002, N258329003, N258329004, N258329005, N258329006, N258329007, N258329008, N258329009, N258329010, N258329011, N258329012, N258329013, N258329014, N258329015, N258329016, N258329017, N258329018, N258329019, N258329020, N258330001, N258330002, N258330003, N258330004, N258330005, N258981001, N258981002, N258981003, N258981004, N258981005, N258981006, N258981007, N258981008, N258981009, N258981010, N258981011, N258981012, N258981013, N258981014, N258981015, N258985001, N258985002, N258985003, N258985004, N258985005, N258985006, N258985007, N258985008, N258985009, N258985010, N258985011, N258985012, N258985013, N258985014, N258985015, N259066001, N259066002, N259066003, N259066004, N259066005, N259425001, N259425002, N259425003, N259425004, N259425005, N259425006, N259425007, N259425008, N259425009, N259425010, N259898001, N259898002, N259898003, N259898004, N259898005, N259898006, N259898007, N259898008, N259898009, N259898010, N259898011, N259900001, N259900002, N259900003, N259900004, N260559001, N260560001, N260560002, N260560003, N260560004, N260560005, N260560006, N260560007, N260560008, N260560009, N260560010, N260560011, N260560012, N260560013, N260560014, N260941001, N260941002, N260941003, N260941004, N260941005, N260946001, N260946002, N260946003, N260946004, N260946005, N260946006, N260946007, N260946008, N260946009, N260946010, N261572001, N261572002, N261572003, N261572004, N261572005, N261572006, N261572007, N261572008, N261572009, N261572010, N261572011, N261572012, N261572013, N261572014, N261572015, N262484001, N262484002, N262484003, N262484004, N262484005, N262484006, N262484007, N262484008, N262484009, N262484010, N262484011, N262484012, N262484013, N262484014, N262484015, N263403001, N263403002, N263403003, N263403004, N263403005, N263403006, N263403007, N263403008, N263403009, N263405001, N263405002, N263405003, N263405004, N263405005, N263405006, N263408001, N263893001, N263893002, N263893003, N263893004, N263893005, N263893006, N263893007, N263893008, N263893009, N263893010, N263893011, N263893012, N263893013, N263893014, N263895001, N263895002, N263895003, N263895004, N263895005, N263895006, N263895007, N263895008, N263895009, N263895010, N263895011, N263895012, N263895013, N263895014, N263895015, N264167001, N264167002, N264167003, N264167004, N264167005, N264167006, N264167007, N264167008, N264167009, N264167010, N264167011, N264167012, N264167013, N264167014, N264167015, N265426001, N265426002, N265426003, N265426004, N265426005, N265426006, N265426007, N265426008, N265426009, N265426010, N265426011, N265426012, N265426013, N265426014, N265426015, N265429001, N265429002, N265429003, N265429004, N265429005, N265429006, N265429007, N265429008, N265429009, N265429010, N265429011, N265429012, N265429013, N265429014, N265429015, N265940001, N265940002, N265940003, N265940004, N265940005, N265940006, N265940007, N265940008, N265940009, N265940010, N268412001, N268412002, N268412003, N268412004, N268412005, N268415001, N268415002, N268415003, N268415004, N268415005, N268415006, N268415007, N268415008, N268415009, N268415010, N268415011, N268415012, N268415013, N268415014, N268415015, N268416001, N268416002, N268416003, N268416004, N268416005, N268416006, N268416007, N268416008, N268416009, N268416010, N268416011, N268416012, N268416013, N268416014, N268416015, N268417001, N268417002, N268417003, N268417004, N268417005, N268417006, N268417007, N268417008, N268417009, N268417010, N268417011, N268417012, N268417013, N268417014, N268417015, N268419001, N268419002, N268419003, N268419004, N268419005, N268424001, N268424002, N268424003, N268424004, N268424005, N268424006, N268424007, N268424008, N268424009, N268424010.
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    3
  • Implanted device?
    Yes
  • 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, Lithuania, Netherlands, Norway, Saudi Arabia, Slovenia, South Africa, Spain, Sweden, Switzerland, Tunisia, United Arab Emirates, United Kingdom.
  • Product Description
    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 that stores and delivers parenteral drugs to the intrathecal space. The implanted infusion system components consist of a Medtronic pump and a Model 8731 or 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.
  • Manufacturer
    Medtronic, Inc. - Neuromodulation

Manufacturer

Medtronic, Inc. - Neuromodulation
  • Manufacturer Address
    Medtronic, Inc. - Neuromodulation, 7000 Central Ave NE, Minneapolis MN 55432-3568
  • Manufacturer Parent Company (2017)
    Medtronic plc
  • Manufacturer comment
    “If our surveillance systems identify a potential performance issue, our personnel promptly evaluate the problem, including, when appropriate, conducting root cause investigations and internal testing to assess whether the product continues to meet specifications and defined performance criteria,” Medtronic told ICIJ in a statement. “In some cases, based on this evaluation, Medtronic may determine that a recall is necessary.” The company said that it communicates with healthcare providers and/or patients and provide recommendations to address such issues. Medtronic noted that these communications can include letters, emails, calls, press releases, physician notifications and social media postings, as well as informing the FDA and other regulators of the actions.
  • Source
    USFDA