Medtronic Enterra Therapy, Gastric Electrical Stimulation System, consisting of model 3116 Enterra Therapy Neurostimulat

FDA device recall Z-0088-2010 · posted 2009-10-29 · Terminated

Recall details

Recalling firm

Medtronic Neuromodulation

Reason for recall

Medtronic is in the process of updating the Enterra Therapy labeling to include information regarding the risks of bowel obstruction and/or perforation. Medtronic has received 15 reports since November 2002 of bowel obstruction and/or perforation of the bowel associated with Enterra Therapy System leads. Of the 15 reported events, 11 required surgical intervention (all patients recovered withou

Action taken

Medtronic Neuromodulation issued a "Medical Device Correction" letter beginning August 25, 2009 addressed to Healthcare Professionals. The letter described the Nature of the Issue, Scope, Potential Severity of the Issue, Enterra Therapy System labeling updating information warnings, Recommendations and other Additional Information. For further information, contact Medronic Neuromodulation Technical Services at 1-800-707-0933.

Root cause

Device Design

Status

Terminated

Product code

LNQ

Quantity affected

1909 (1095 US, 814 OUS)

Distribution

Worldwide Distribution.

Date initiated

2009-08-25

Date posted

2009-10-29

Date terminated

2012-05-22

Location

Minneapolis, MN