Product Wiki · Recalls · Health Canada — Medical Devices

Formula 418 Renal Balloon-Expandable Stent (2020-04-14) — recall 63388

Health Canada — Medical Devices · Canada · 2020-05-01 · Type II

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Agency
Health Canada — Medical Devices
Recall identifier
63388
Date of alert
2020-05-01
Country / jurisdiction
Canada
Risk level
Type II
Risk type
recall
Product category
Medical devices
Product type
Medical devices
Reported risk: Cook Medical Inc. has received complaints on five devices from this lot where the stent dislodged from the balloon delivery system prior to deployment. Due to the number of complaint devices from this product lot, Cook Medical Inc. is initiating a lot specific voluntary recall.
Primary source: https://recalls-rappels.canada.ca/en/alert-recall/formula-418-renal-balloon-expa

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.

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