Z-1573-2013 Class I Terminated

Recalled by Medtronic Neuromodulation — Minneapolis, MN

FDA device recall Z-1573-2013 was initiated by Medtronic Neuromodulation on Jun 3, 2013 and is designated Class I. 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… The recall status is terminated (terminated Apr 7, 2014). Affected quantity: 115,722 total.

Recall Details

Product Type
Devices
Report Date
Jul 3, 2013
Initiation Date
Jun 3, 2013
Termination Date
Apr 7, 2014
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
115,722 total

Product Description

Medtronic Sutureless Pump Connector Revision Kit, model 8578. Contents: catheter interface with attached sutureless pump connector, catheter, connector pin, and strain-relief sleeve to be used with Medtronic SynchroMed implantable drug infusion pumps. Contents of inner package are STERILE. The Medtronic Model 8578 Sutureless Pump Connector Revision Kit is used when a pump connector for an Indura 1P Model 8709 or Model 8709SC 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 an Indura 1P Model 8709 or Model 8709SC catheter. The catheter connects to the pump with the Model 8578 sutureless pump connector at the catheter port.

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.

Distribution Pattern

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.

Code Information

Product having a Use By Date prior to 25 Aug 2014

Source

Dataset
openFDA device recall enforcement reports
FDA record
This recall in openFDA (JSON)
Enforcement Report
Search FDA's Enforcement Report for Z-1573-2013
openFDA file date
Oct 23, 2026
Loaded by RegDataLab
Oct 26, 2026

These dates say when openFDA published the data file and when RegDataLab last loaded it.