Product Wiki · Recalls · Health Canada — Medical Devices

VNS Therapy Model 105 AspireHC Generator — recall 44480

Health Canada — Medical Devices · Canada · 2017-07-17 · Type II

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Agency: Health Canada — Medical Devices
Recall identifier: 44480
Date of alert: 2017-07-17
Country / jurisdiction: Canada
Risk level: Type II
Risk type: recall
Product category: Medical devices
Product type: Medical devices
Notice status: Archived by the issuing authority — kept for reference

Reported risk: Livanova is notifying customers that certain Model 105 AspireHC and Model 106 AspireSR VNS therapy generators are subject to the potential for reduced battery longevity associated with the manufacturing process used to assemble the circuit board. Physicians of patients with implanted devices are being notified to monitor their impacted patient(s) frequently to check battery status. Only Model 105 devices were imported and distributed in Canada.

Primary source: https://recalls-rappels.canada.ca/en/alert-recall/vns-therapy-model-105-aspirehc

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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.

VNS Therapy Model 105 AspireHC Generator — recall 44480

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