Penumbra System RED 68 Reperfusion Catheter
Brand(s)
Last updated
Summary
Product
Penumbra System RED 68 Reperfusion Catheter
Issue
Medical devices - Performance
What to do
Notification of customers. Return affected devices.
Audience
Healthcare
Affected 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.
Additional information
Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - Cardiovascular
Companies
Penumbra Inc.
One Penumbra Place, Alameda, California, United States, 94502
Published by
Health Canada
Audience
Healthcare
Recall class
Type II
Recall date
Identification number
RA-82240
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