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Penumbra system red 68 reperfusion catheter

Official notice

22 Jun 2026

CriticalHealth Canada

An official Health Canada notice concerns Penumbra system red 68 reperfusion catheter. 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. Published 2026-06-22.

What to do now

Notification of customers. Return affected devices.

Recall number

82240

Official notice

2026-06-22

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.

How to check if you're affected

Compare the product name and identifiers below with the item you own. Follow the official notice if they match.

Lots

C00020038, H00008701, H00008703, H00008702, H00008699

Skus

RED68KIT

Other

RA RA-82240

Model Numbers

RED68KIT

Recall Numbers

82240

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Affected products

Product 1

Lot or serial number - C00020038, Model or catalogue number - RED68KIT

Product 2

Lot or serial number - H00008701, Model or catalogue number - RED68KIT

Product 3

Lot or serial number - H00008703, Model or catalogue number - RED68KIT

Product 4

Lot or serial number - H00008702, Model or catalogue number - RED68KIT

Product 5

Lot or serial number - H00008699, Model or catalogue number - RED68KIT

Risk / 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.

Where it was sold

The source does not list specific retailers. See the official notice for where affected products were sold.

Location 1

CA · Canada

Affected area 1

CA · Canada

Company & contacts

Manufacturer

Not provided

Phone

Not provided

Brand: Penumbra.

Source & status

Source

Health Canada

Tier

beta

Category

HEALTH

Classification

Type II

App estimate

critical

Recall details

Recall number

82240

Classification

Type II

Source tier

beta

Documents, notices & source

See the official notice and source documents for full details.

View full official notice
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