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

Recall Z-2124-2020 — Fifty-five (55) cm 8 Contact Extension Kit, part number M365SC3138550 - Product Usage: Lead Extensions are designed to connect the percutaneous leads to the Implantable Pulse Generator (IPG) for spinal cord stimulation. The extension may be added to a lead to externalize the lead for a trial proce

U.S. FDA — Device Enforcement · United States · 2019-04-24 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-2124-2020
Date of alert: 2019-04-24
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Boston Scientific Neuromodulation Corporation
Product category: device
Product type: Devices

Reported risk: The firm is initiating a voluntary removal of certain spinal cord stimulation leads, lead extensions, adapters, and deep brain stimulation lead extensions due to the "use by date" displayed on the label which is later than the correct "use by date". No adverse health consequence is expected to occur from this issue.

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

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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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