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Medtronic Neuromodulation recalls Medtronic SynchroMed II Implantable Infusion Pumps, models 8637-20 and 8637-40. Sterile. Product Usage: The implant
Recalled June 3, 2015 · FDA recall Z-1681-2015 · Medtronic Neuromodulation
Hazard
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. · FDA Class II
Units
1901 (1576 US, 325 OUS)
Sold at
Worldwide Distribution - US Nationwide including DC AND PR and in the countries of : Argentina, Austria, Belgium, France, Germany, Ireland, Italy, Japan, Luxembourg, Malta, Netherlands, Norway, Panama, Poland, Portugal, Russian Federation, San Marino, Saudi Arabia, South Korea, Spain, Switzerland, and United Kingdom.
Description
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.
Product
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
Manufacturer(s)
Medtronic Neuromodulation
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →