Product Wiki · Recalls · Health Canada — Medical Devices

CODMAN CERTAS THERAPY MANAGEMENT SYSTEM6 (2015-06-24) — recall 53877

Health Canada — Medical Devices · Canada · 2015-07-08 · Type II

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Agency
Health Canada — Medical Devices
Recall identifier
53877
Date of alert
2015-07-08
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: CODMAN Neuro is recalling and replacing the CODMAN CERTAS Therapy Management System (TMS), 1st generation, with the CODMAN CERTAS tool kit, 2nd generation, that contains improvements for the indication and adjustment of the valve setting. Some components of the 1st generation are not compatible with the components of the 2nd generation, and the incompatibility could result in reduced indicating/adjusting performance and lead to symptoms associated with over/under drainage of cerebrospinal fluid. This incompatibility is between tool kit components only.
Primary source: https://recalls-rappels.canada.ca/en/alert-recall/codman-certas-therapy-manageme

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