Medtronic SynchroMed II Programmable Pump, 8637, Rx Only, Sterilized by ethylene oxide gas, Medtronic inc., Minneapolis,

FDA device recall Z-2276-2009 · posted 2009-09-29 · Terminated

Recall details

Recalling firm

Medtronic Neuromodulation

Reason for recall

This recall is related to the potential for reduced battery performance in a small percentage of Medtronic Model 8637 SynchroMed II pumps with batteries manufactured during two distinct time periods prior to April 2005. Nature of the Device Issue: As part of ongoing analysis of returned explanted product, Medtronic has confirmed that reduced battery performance resulted in eight (8) occurrence

Action taken

Consignees were sent on July 7, 2009 a Medtronic " Urgent: Medical Device Correction" letter dated July 2009. The letter was addressed to Healthcare Professionals. The letter described the nature of the Device Issue, Scope, Potential Severity of the Issue, Recommendations, Ongoing patient Management Recommendations and Additional Information. Important patient management information is also available at http://www.professional.medtronic.com under the heading Product Advisories. Direct questions to your Medtronic Field Representative or Medtronic Neuromodulation Technical Services by calling at 1-800-707-0933.

Root cause

Nonconforming Material/Component

Status

Terminated

Product code

LKK

Quantity affected

18,572

Distribution

US (including DC and Puerto Rico), Australia, India, canada, Hong Kong, Japan, Austria, Belgium Cyprus, Denmark, Egypt, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Luxembourg,

Date initiated

2009-07-01

Date posted

2009-09-29

Date terminated

2012-05-10

Location

Minneapolis, MN