Pipeline Flex Embolization Device (2021-07-19)

Starting date:

July 19, 2021

Posting date:

July 27, 2021

Type of communication:

Medical Device Recall

Subcategory:

Medical Device

Hazard classification:

Type II

Source of recall:

Health Canada

Issue:

Medical Devices

Audience:

General Public, Healthcare Professionals, Hospitals

Identification number:

RA-76107

Last updated:
2021-07-27

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  Reason
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  Affected products

Affected Products 

A. Pipeline Flex Embolization Device

B. Pipeline Flex Embolization Device with Shield Technology

Reason

Medtronic has received reports of serious injuries and deaths in connection with delivery pushwire fracture at the distal section of the Pipeline Flex delivery system during use. Use of impacted product may result in unintended fracture, where the distal portion of the pushwire separates from the device delivery system during delivery and deployment. If separation occurs, it may result in significant patient injury, including a prolonged procedure, foreign body, ischemic stroke, intracranial hemorrhage, neurological deficit, and/or death. The risk of fracture presents only intra-operatively. If a Pipeline Flex embolization device has already been implanted successfully, there is no increased risk to patients due to the issue. Those patients with an implanted device should continue with their normal course of treatment.

Affected products