Product Wiki · Recalls · Health Canada — Marketed Health Products

Archived — recall 25585

Health Canada — Marketed Health Products · Canada · 2002-07-29

As described by Health Canada — Marketed Health Products: Archived – Cochlear Implant Recipients may be at Greater Risk for Meningitis

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Agency
Health Canada — Marketed Health Products
Recall identifier
25585
Date of alert
2002-07-29
Country / jurisdiction
Canada
Risk type
recall
Product category
Medical devices
Product type
Marketed health products
Notice status
Archived by the issuing authority — kept for reference
Reported risk: Health Canada has become aware of information issued by the US-FDA concerning a possible association between cochlear implants and the occurrence of bacterial meningitis . It was stated in the FDA Public Health Web Notification on July 24/2002 ( http://www.fda.gov/cdrh/safety/cochlear.html ). "At least 25 cases of meningitis have been diagnosed worldwide in children and adults ranging in age from 21 months to 63 years who have undergone cochlear implantation for severe to profound deafness. A total of 9 known deaths resulted from these cases. At this time, 2 out of 3 companies have reported cases of bacterial meningitis in patients who have been implanted.
Primary source: https://recalls-rappels.canada.ca/en/alert-recall/archived-cochlear-implant-reci

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