Reported Jun 3, 2015 · Terminated
Medtronic SynchroMed II Implantable Infusion Pumps, models 8637-20 and 8637-40. Sterile. Product Usage: The implantable…
Medtronic Neuromodulation
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Medtronic Neuromodulation · 7000 Central Ave Ne · Minneapolis, MN · 55432-3568
Is this the product you have?
- Medtronic SynchroMed II Implantable Infusion Pumps, models 8637-20 and 8637-40. Sterile
- Product UsageThe 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
- Lot codes and dates
- US Serial NumberOUS Serial Number
1,576 of 1,576 codes
NGP411628HNGP411629HNGP411685HNGP411704HNGP411801HNGV501193HNGP410146HNGP410147HNGP410148HNGP410149HNGP410151HNGP410153HNGP410156HNGP410160HNGP410162HNGP410163HNGP410169HNGP410171HNGP410175HNGP410177HNGP410178HNGP410179HNGP410181HNGP410182HNGP410183HNGP410184HNGP410186HNGP410188HNGP410189HNGP410190HNGP410191HNGP410196HNGP410197HNGP410198HNGP410200HNGP410201HNGP410204HNGP410206HNGP410213HNGP410215HNGP410216HNGP410217HNGP410219HNGP410220HNGP410221HNGP410223HNGP410230HNGP410231HNGP410233HNGP410234HNGP410237HNGP410240HNGP410241HNGP410244HNGP410950HNGP410956HNGP410964HNGP410968HNGP410969HNGP410970H
325 of 325 codes
NGP410145HNGP410155HNGP410157HNGP410158HNGP410159HNGP410165HNGP410166HNGP410174HNGP410187HNGP410194HNGP410203HNGP410209HNGP410212HNGP410224HNGP410225HNGP410226HNGP410227HNGP410228HNGP410229HNGP410232HNGP410243HNGP411106HNGP411109HNGP411112HNGP411115HNGP411116HNGP411119HNGP411121HNGP411122HNGP411124HNGP411125HNGP411126HNGP411130HNGP411137HNGP411140HNGP411141HNGP411145HNGP411148HNGP411150HNGP411151HNGP411152HNGP411153HNGP411156HNGP411160HNGP411166HNGP411167HNGP411168HNGP411170HNGP411172HNGP411173HNGP411174HNGP411175HNGP411177HNGP411180HNGP411181HNGP411182HNGP411184HNGP411185HNGP411188HNGP411190H
- US Serial Number
- Amount recalled
- 1901 (1576 US, 325 OUS)
Where it was sold
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.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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