Z-0497-2013 Class I Terminated
FDA device recall Z-0497-2013 was initiated by Medtronic Neuromodulation on Nov 9, 2012 and is designated Class I. Reason for recall: Medtronic notified Healthcare Professionals of the impact of unapproved drugs on the performance of the SynchroMed infusion pump system. Use of unapproved drugs with SynchroMed pumps can result in an… The recall status is terminated (terminated Dec 31, 2017). Affected quantity: 174,700 devices total.
Recall Details
- Product Type
- Devices
- Report Date
- Dec 19, 2012
- Initiation Date
- Nov 9, 2012
- Termination Date
- Dec 31, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 174,700 devices total
Product Description
Medtronic SynchroMed II, Model 8637, (The SynchroMed¿ II Pump is supplied in 20 ml or 40 ml reservoir size.) Sterilized using ethylene oxide. The pump is part of an infusion system that stores and delivers a prescribed drug to a specific site. The implantable components of the SynchroMed II Infusion System include the pump, catheter, and catheter accessories.
Reason for Recall
Medtronic notified Healthcare Professionals of the impact of unapproved drugs on the performance of the SynchroMed infusion pump system. Use of unapproved drugs with SynchroMed pumps can result in an increased risk of permanent motor stall and cessation of drug infusion. UPDATE 2/1/2016: Medtronic received approval to incorporate enhancements to the SynchroMed II pump which decreases the potential for internal electrical shorting and motor corrosion, and is retrieving any unused pumps.
Distribution Pattern
Worldwide distribution: USA (nationwide) and countries including: Canada and Mexico.
Code Information
All SynchroMed EL and SynchroMed II pumps
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0497-2013
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026