Penumbra System Red 68 Reperfusion Catheter

Penumbra Inc. is recalling the Penumbra System RED 68 Reperfusion Catheter across Canada due to a device performance issue. This catheter is a medical device used in certain medical procedures. The recall affects all units of this product that were distributed in Canada.

Product

Penumbra System RED 68 Reperfusion Catheter

Reason

Device performance issue

Classification

Class II

Category

medical device recall

Country

Canada

Agency

HC-DEVICES

Recall date

2026-06-22

Status

Ongoing

Distribution

Canada-wide

Official recall notice from HC-DEVICES

Recall details on Nibble Recalls: https://trynibble.app/recalls/ff7486ea-1097-4e0b-9c2b-d4e5503973c2