Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Medtronic SynchroMed II Implantable Infusion Pumps Recalled by Medtronic Neuromodulation Due to Medtronic is conducting a recall of a specific...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Medtronic Neuromodulation directly.
Affected Products
Medtronic SynchroMed II Implantable Infusion Pumps, models 8637-20 and 8637-40. Sterile. Product Usage: The implantable Medtronic SynchroMed II programmable pumps are part of an infusion system that stores and delivers a prescribed drug to a specific site. The implanted infusion system consists of a SynchroMed II pump and a catheter
Quantity: 1901 (1576 US, 325 OUS)
Why Was This Recalled?
Medtronic is conducting a recall of a specific subset of Model 8637-20 and 8637-40 SynchroMed II implantable drug pumps because the audible alarm could cease to function.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Medtronic Neuromodulation
Medtronic Neuromodulation has 95 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report