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Enterra® II
MEDTRONIC, INC. · Model 37800 · UDI-DI 00763000449704
LNQ
Prescription
0
510(k) clearances
4,382
Adverse events (74 deaths)
1
Recalls
5
Facilities
Description
INS 37800 ENTERRA II EMAN US
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2009-08-25 | Medtronic Neuromodulation | 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 |
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Get your free API keyRead the docsData 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.