CanadaThe Penumbra System RED 68 Reperfusion Catheter (model RED68KIT) from Penumbra Inc. is affected — lots/serial numbers C00020038, H00008701, H00008703, H00008702 and H00008699. The lots may result in potential fracture of the catheter, which may result in patient injury or death; Penumbra has not received reports of patient injury related to these fractures. Customers have been notified and should return affected devices.
What's being recalled
Companies: Penumbra Inc., One Penumbra Place, Alameda, California, United States, 94502.
How to identify it
Affected products: Penumbra System RED 68 Reperfusion Catheter; Lot or serial number: C00020038; Model or catalogue number: RED68KIT
Affected products: Penumbra System RED 68 Reperfusion Catheter; Lot or serial number: H00008701; Model or catalogue number: RED68KIT
Affected products: Penumbra System RED 68 Reperfusion Catheter; Lot or serial number: H00008703; Model or catalogue number: RED68KIT
Affected products: Penumbra System RED 68 Reperfusion Catheter; Lot or serial number: H00008702; Model or catalogue number: RED68KIT
Affected products: Penumbra System RED 68 Reperfusion Catheter; Lot or serial number: H00008699; Model or catalogue number: RED68KIT
The hazard
Penumbra has identified an issue in the lots of RED 68 specified in this notification which may result in potential fracture of the device. Penumbra has not received reports of any events involving patient injury related to these fractures; however, fracture of the catheter may result in patient injury or death.
What to do
Notification of customers. Return affected devices.
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)
United States