Medtronic Enterra Therapy, Gastric Electrical Stimulation System, consisting of model 3116 Enterra Therapy Neurostimulator and model 4351 Unipolar Intramuscular Lead. Medtronic, Inc., 710 Medtronic Parkway, Minneapolis, MN 55432-5604 USA. The Neurostimulator (implantable neurostimulator or INS) is a multiprogrammable device designed to deliver therapy through gastric electrical stimulation when connected to a lead system. Humanitarian Device: Authorized by Federal Law for use in treatment of chronic intractable (drug refractory) nausea and vomiting secondary to gastroparesis of diabetic or idiopathic etiology.
FDA Recall Z-0088-2010 · Posted 2009-10-29
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Recalling FirmMedtronic Neuromodulation
Recall StatusTerminated
Product CodeLNQ
Date Initiated2009-08-25
Date Terminated2012-05-22
Product Quantity1909 (1095 US, 814 OUS)
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
Firm Action
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
Distribution Pattern
Worldwide Distribution.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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