| | Class 1 Recall
SynchroMed II implantable infusion pump |  |
| Date Posted |
December 13, 2012 |
| Recall Number |
Z-0497-2013 |
| Product |
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. |
| Code Information |
All SynchroMed EL and SynchroMed II pumps
|
Recalling Firm/
Manufacturer |
Medtronic Neuromodulation
7000 Central Ave NE
Minneapolis, Minnesota 55432-3568 |
| For Additional Information Contact |
Medtronic Technical Services
800-707-0933
|
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.
|
| Action |
The firm Medtronic, sent an "Urgent medical Device Safety Notification" dated November 2012, to its customers beginning November 09, 2012. The letter described the product, problem and actions to be taken. The customers were instructed to follow the recommendations provided in the letter and complete and return the PHYSICIAN REPLY FORM via mail at Medtronic Neuromodulation Quality Assurance, 7000 Central Ave NE, Mailstop RCC150, Minneapolis, MN 55432; fax to: 800-897-3899 or email to: neuro.quality@medtronic.com.
If you have questions, please contact Medtronic Neuromodulation Technical Services at 1-800-707-0933 weekdays 7am - 6pm CST. |
| Quantity in Commerce |
174,700 devices total |
| Distribution |
Worldwide distribution: USA (nationwide) and countries including: Canada and Mexico. |
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