Enforcement Report - Week of December 19, 2012
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Product Detail
| 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. |
|---|---|
| Recall Number | Z-0497-2013 |
| Classification | Class I |
| Code Info | All SynchroMed EL and SynchroMed II pumps |
| Product Distributed Qty | 174,700 devices total |
| 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. |
Event Detail
| Event Id | 63712 |
|---|---|
| Product Type | Devices |
| Status | Ongoing |
| Recalling Firm | Medtronic Neuromodulation |
| City | Minneapolis |
| State | MN | Country | US |
| Voluntary / Mandated | Voluntary: Firm Initiated |
| Recall Initiation Date | 2012-11-09 |
| Initial Firm Notification of Consignee or Public | Letter |
| Distribution Pattern | Worldwide distribution: USA (nationwide) and countries including: Canada and Mexico. |
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