Public recall detail

Penumbra System RED 68 Reperfusion Catheter

2026-06-22

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Health products Health product recall
Quick summary

Quick summary: Penumbra System RED 68 Reperfusion Catheter. Reason: Health product recall. Category: Health products. Date: 2026-06-22.

Recommended action

Recommended action: compare your product with the official notice and follow the instructions published by the official source.

Recall details

Quick summary: Penumbra System RED 68 Reperfusion Catheter. Reason: Health product recall. Category: Health products. Date: 2026-06-22.

Official details

Affected product details

Structured information extracted from the official recall notice. Confirm the identifiers and instructions in the original notice.

BrandPenumbra Inc.
ProductPenumbra System RED 68 Reperfusion Catheter
IssueMedical devices - Performance
Recall classType II
IdentificationRA-82240

Affected products

ProductPenumbra System RED 68 Reperfusion Catheter
LotC00020038
ModelRED68KIT
Serial numberC00020038
DescriptionPenumbra System RED 68 Reperfusion Catheter
ProductPenumbra System RED 68 Reperfusion Catheter
LotH00008701
ModelRED68KIT
Serial numberH00008701
DescriptionPenumbra System RED 68 Reperfusion Catheter
ProductPenumbra System RED 68 Reperfusion Catheter
LotH00008703
ModelRED68KIT
Serial numberH00008703
DescriptionPenumbra System RED 68 Reperfusion Catheter
ProductPenumbra System RED 68 Reperfusion Catheter
LotH00008702
ModelRED68KIT
Serial numberH00008702
DescriptionPenumbra System RED 68 Reperfusion Catheter
ProductPenumbra System RED 68 Reperfusion Catheter
LotH00008699
ModelRED68KIT
Serial numberH00008699
DescriptionPenumbra System RED 68 Reperfusion Catheter

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.

What you should do

  • Notification of customers. Return affected devices.
Additional official information
AudienceHealthcare
CategoryHealth products - Medical devices - Cardiovascular
CompaniesPenumbra Inc.One Penumbra Place, Alameda, California, United States, 94502
Recall date2026-06-03
Published byHealth Canada
Recall classType II
Alert / recall typeHealth product recall
Identification numberRA-82240
Background{}
CompaniesPenumbra Inc.One Penumbra Place, Alameda, California, United States, 94502
AudiencesHealthcare
Source updated2026-06-22

Contains information licensed under the Open Government Licence – Canada. SafetyPulse is independent of the Government of Canada.

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