Medtronic Neuromodulation recalls Medtronic SynchroMed II Implantable Infusion Pumps, models 8637-20 and 8637-40. Sterile. Product Usage: The implantable…

Recall date

April 10, 2015

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1681-2015

FDA classification

Class II

Brand / firm

Medtronic Neuromodulation

Sold / distributed

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,…

Why it was 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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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