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

Recall Z-0788-2017 — Medtronic SynchroMed II Implantable Drug Infusion System. This system includes: Model 8870 Software Application Card, Model 8840 N'Vision Clinician Programmer, and Model 8637 SynchroMed II Implantable Drug Infusion Pump (supplied in 20 ml or 40 ml reservoir size.) Product Usage: The Synchro

U.S. FDA — Device Enforcement · United States · 2016-10-03 · Class I

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-0788-2017
Date of alert: 2016-10-03
Country / jurisdiction: United States
Risk level: Class I
Risk type: recall
Brand: Medtronic Neuromodulation
Product category: device
Product type: Devices

Reported risk: Medtronic is following up to a May 2013 communication regarding the Priming Bolus function for the SynchroMed Infusion System. Medtronic is updating the Model 8870 software application card (to version AAU01) and the SynchroMed pump labeling to address the priming bolus issue.

Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.

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