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N'VISION®

MEDTRONIC, INC. · Model 8870MMC01 · UDI-DI 00763000129514

LNQ EZW QON Prescription

510(k) clearances

4,398

Adverse events (75 deaths)

Recalls

Facilities

Description

SW 8870MMC01 NVISION INTSTM ENTERRA2

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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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.