Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-0615-2024 — Medtronic SynchroMed II, Model 8637-40, Programmable pump

U.S. FDA — Device Enforcement · United States · 2023-11-13 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0615-2024
Date of alert
2023-11-13
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Medtronic Neuromodulation
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
00613994483195
Reported risk: Medtronic recently identified that if the SynchroMed II pump switches into telemetry mode due to electromagnetic interference (EMI) from an MRI scan, while the pump is sounding an alarm, the pump will not resume drug delivery after leaving the MRI magnetic field, which is inconsistent with the current labeling.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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