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ENTERRA ™

MEDTRONIC, INC. · Model 4351-35 · UDI-DI 00643169887589

LNQ Prescription
0
510(k) clearances
4,382
Adverse events (74 deaths)
1
Recalls
5
Facilities

Description

LEAD 4351-35 ENTERRA GASTRIC EMAN FWU

Recalls

DateFirmReason
2009-08-25Medtronic NeuromodulationMedtronic 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

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.