Recall MonitorHealth Products
Penumbra System RED 68 Reperfusion Catheter
· Published by Health Canada · Official notice
Details
Alert type: Health product recall
Category: Health products - Medical devices - Cardiovascular
Product: Penumbra System RED 68 Reperfusion Catheter
Issue: Medical devices - Performance
What to do: Notification of customers. Return affected devices.
Audience: Healthcare
Recall class: Type II
Products
| Affected products | Lot or serial number | Model or catalogue number |
|---|---|---|
| Penumbra System RED 68 Reperfusion Catheter | C00020038 | RED68KIT |
| Penumbra System RED 68 Reperfusion Catheter | H00008701 | RED68KIT |
| Penumbra System RED 68 Reperfusion Catheter | H00008703 | RED68KIT |
| Penumbra System RED 68 Reperfusion Catheter | H00008702 | RED68KIT |
| Penumbra System RED 68 Reperfusion Catheter | H00008699 | RED68KIT |
Issue
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.