Z-1575-2013Class I

Medtronic INDURA 1P Intrathecal Catheter, model 8709SC. Contents: 81.4-cm catheter with length markers and...

Name: Z-1575-2013 Medtronic INDURA 1P Intrathecal Catheter, model 8709SC. Contents: 81.4-cm catheter with length markers and...
Creator: Medtronic Neuromodulation
Published: 2013-06-03
License: https://open.fda.gov/license/

Medtronic Neuromodulation / initiated 2013-06-03 / Terminated / root cause: design

FDA source

Medtronic Neuromodulation began a recall of Medtronic INDURA 1P Intrathecal Catheter, model 8709SC. Contents: 81.4-cm catheter with length markers and guide wire, 15 T-gauge introducer needle, Sutureless... on 2013-06-03. FDA classified it as Class I and gives the reason as "The Sutureless Connector (SC) Intrathecal Catheter connector has been redesigned to reduce the potential for occlusion at the catheter to pump interface. Medtronic is removing the unused products from the market that...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-1575-2013
Classification: Class I
Status: Terminated
Initiated: 2013-06-03
Posted: 2013-06-24
Terminated: 2014-04-07
Recalling firm: Medtronic Neuromodulation
Product: Medtronic INDURA 1P Intrathecal Catheter, model 8709SC. Contents: 81.4-cm catheter with length markers and guide wire, 15 T-gauge introducer needle, Sutureless pump connector with attached 7.6-cm catheter and Connector pin, Transparent Strain-relief sleeves, and anchors. Contents of inner package are STERILE. The implantable Medtronic INDURA 1P Model 8709SC 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 8709SC catheter. The catheter connects to the pump at the catheter port.
Product code: LKK Pump, Infusion, Implanted, Programmable
Reason for recall: The Sutureless Connector (SC) Intrathecal Catheter connector has been redesigned to reduce the potential for occlusion at the catheter to pump interface. Medtronic is removing the unused products from the market that were manufactured with the previous design, and recommend the previous design no longer be used due to greater potential for misalignment and subsequent occlusion.
Root cause tag: design
FDA root cause: Device Design
Action: The firm, Medtronic, sent an "Urgent: Medical Device Removal" letter dated May 2013 to its customers. The letter described the product, problem and actions to be taken. Representatives (Rep) are visiting all locations, beginning June 3, 2013, to retrieve devices with a Use By date of 2014 08 14 (August 14, 2014) or sooner. The Rep is leaving a letter with the hospitals to tell them that the Sutureless Connector Intrathecal Catheter connector has been redesigned and that they are removing unused devices. They also do not recommend using any of the old design. An Account Specific Customer Confirmation Form will be completed by the Rep. A copy of the completed form will be left with the Hospital along with the Urgent Medical Device Removal letter. If you have questions, please contact Medtronic Neuromodulation Technical Services at 1-800-707-0933 weekdays 7am - 6pm CST.
Quantity in commerce: 115,7422 total
Distribution: Worldwide distribution: US (nationwide) and countries of: Aruba, Australia, Austria, Belgium, Canada, Chile, China, Colombia, Costa Rica, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Finland, France, Georgia, Germany, Greece, Guadeloupe, Hong Kong, Hungary, Iceland, India, Ireland, Israel, Italy, Jordan, Korea, Kuwait, Lebanon, Lithuania, Luxembourg, Malta, Martinique, Morocco, Netherlands, Netherlands Antilles, New Zealand, Norway, Panama, Poland, Portugal, Puerto Rico, Qatar, Romania, Russian Federation, San Marino, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Sweden, Switzerland, Thailand, Trinidad and Tobago, Turkey, United Arab Emirates, United Kingdom, Uruguay, and Venezuela.
Product codes and lots: Product having a Use By Date prior to 25 Aug 2014

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1575-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1573-2013	Class I	Terminated	Voluntary: Firm initiated	2013-07-03	2013-06-25
Z-1574-2013	Class I	Terminated	Voluntary: Firm initiated	2013-07-03	2013-06-25
Z-1575-2013	Class I	Terminated	Voluntary: Firm initiated	2013-07-03	2013-06-25
Z-1576-2013	Class I	Terminated	Voluntary: Firm initiated	2013-07-03	2013-06-25

Product code LKK

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)