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.
Enforcement
- Recall Number
- Z-0497-2013
- Event ID
- 63712
- Classification
- Class I
- Status
- Terminated
- Product Type
- Devices
- Firm
- Medtronic Neuromodulation
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- December 19, 2012
- Initiation Date
- November 9, 2012
- Classification Date
- December 13, 2012
- Termination Date
- December 31, 2017
- Address
- 7000 Central Ave NE, N/A, Minneapolis, MN, 55432-3568, United States
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.
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.
All SynchroMed EL and SynchroMed II pumps
Worldwide distribution: USA (nationwide) and countries including: Canada and Mexico.
174,700 devices total