Penumbra System RED 68 Reperfusion Catheter Recall Canada 2026

Health Canada has issued a Type II health product recall for the Penumbra System RED 68 Reperfusion Catheter, manufactured by Penumbra Inc. The recall, identified under reference number RA-82240, affects five specific lot numbers of the cardiovascular medical device sold under model number RED68KIT. The recall was initiated on 2026-06-03 due to a potential device fracture risk that could lead to serious patient injury or death.

What Products Are Being Recalled?

The affected product is the Penumbra System RED 68 Reperfusion Catheter (Model: RED68KIT), manufactured by Penumbra Inc., headquartered at One Penumbra Place, Alameda, California, United States. The following specific lot numbers are subject to this recall:

• Lot C00020038
• Lot H00008699
• Lot H00008701
• Lot H00008702
• Lot H00008703

These devices fall under the cardiovascular category of health products and are intended for use by healthcare professionals in clinical settings.

Why Was This Recall Issued?

Penumbra Inc. identified a manufacturing or performance issue in the specific lots listed above that may result in a potential fracture of the catheter device. The company has reported that, as of the time of this recall notification, no patient injuries related to device fractures from these lots have been received. However, Health Canada and Penumbra Inc. emphasize that a fractured reperfusion catheter carries a serious risk of patient injury or death if left in clinical use. The recall is classified as a Type II recall, meaning the product may cause temporary adverse health consequences, or the probability of serious adverse health consequences is remote but cannot be ruled out.

Who Is Affected?

This recall is directed at the healthcare audience, including hospitals, clinics, surgical centres, and medical professionals who have purchased or are currently using the Penumbra System RED 68 Reperfusion Catheter from the affected lot numbers. Patients who have undergone procedures using these devices should consult with their healthcare provider if they have any concerns. The recall applies specifically within Canada, as published by Health Canada under the national recall and safety alerts program.

What Should You Do?

• Healthcare facilities and professionals should immediately check their inventory for the affected lot numbers: C00020038, H00008699, H00008701, H00008702, and H00008703 (Model RED68KIT).
• Do not use any units from the recalled lot numbers. Quarantine and remove these devices from service immediately.
• Return all affected devices to Penumbra Inc. as instructed in the customer notification.
• Contact Penumbra Inc. directly for guidance on the return process and any replacement arrangements. The company is based at One Penumbra Place, Alameda, California, United States, 94502.
• Healthcare providers should document the removal of affected products from inventory and report any adverse events or device-related concerns to Health Canada.
• For further inquiries or to report a health or safety concern, visit the Health Canada reporting portal at canada.ca or contact Health Canada directly.

Official Statement

According to the official recall notice published by Health Canada: ‘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.’ Health Canada continues to monitor the situation and encourages all affected healthcare providers to act promptly in accordance with the recall instructions. Consumers and healthcare professionals can subscribe to Health Canada recall notifications at recalls-rappels.canada.ca to stay informed about future alerts and safety advisories.