CanadaThe Instinct® Plus Endoscopic Clipping Device (model INSC-P-7-230-S; affected lot/serial numbers: more than 10 numbers—contact the manufacturer) is affected. It was recalled after 486 complaints that the clip housing can detach from the catheter attachment so the clip remains attached to the internal drive wire and extends without the jaws opening; products manufactured before corrective actions were implemented are being withdrawn. Contact the manufacturer for additional information.
What's being recalled
Companies: Wilson-Cook Medical, Inc., 4900 Bethania Station Rd., Winston Salem, North Carolina, United States, 27105.
How to identify it
Affected products: Instinct® Plus Endoscopic Clipping Device; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: INSC-P-7-230-S
The hazard
Cook Medical has received 486 complaints of a malfunction that occurs when the user attempts to open the clip jaws by actuating the handle. The malfunction that may occur is the clip housing detaching from the catheter attachment and the clip remaining attached to the drive wire. The clip will extend from the catheter, but it will remain attached to the internal drive wire instead of opening the clip jaws. The clip cannot be opened if this occurs.
Corrective actions have been implemented to mitigate the risk of this failure mode. This action is being taken to withdraw products manufactured prior to the implementation of the corrective actions.
What to do
Contact the manufacturer if you require additional information.
The official notice
This page is a summary of the notice published by Health Canada, collected from Health Canada, CFIA and Transport Canada. Check the original before you act on it.
Read the official notice (opens in a new tab)