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

FDA device recall Z-1681-2015 · posted 2015-05-28 · Terminated

Recall details

Recalling firm

Medtronic Neuromodulation

Reason for recall

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.

Action taken

Customers were sent a Medtronic "Urgent Medical Device Removal" letter dated April 2015. The letter described the problem and the product involved in the recall. The letter described the "Required Actions" which included to quarantine and return the product, complete and return the Customer Confirmation Form, and to share the notification with other customers. For questions, they can contact Medtronic Neuromodulation Technical Services at 1-800-707-0933. A second letter was sent to Healthcare Professional. The "Urgent Medical Device Correction" letter dated April 2015 described the Nature of the Device Issue, Scope and Likelihood of the Issue, Recommendations, Patient Management Recommendations and Additional Information. Advise consignees to report any malfunction or adverse event related to a device to Medtronic Neuromodulation Technical Services, at 1-800-707-0933 available weekdays from 7 am - 6pm Central Time, and to FDA'ss MedWatch Program (www.fda.gov/medwatch).

Root cause

Process control

Status

Terminated

Product code

LKK

Quantity affected

1901 (1576 US, 325 OUS)

Distribution

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

Date initiated

2015-04-10

Date posted

2015-05-28

Date terminated

2015-11-23

Location

Minneapolis, MN