PIPELINE FLEX EMBOLIZATION DEVICE (2020-09-08)

Starting date:

September 8, 2020

Posting date:

October 2, 2020

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-74041

Last updated:
2020-10-01

• 
  Reason
• 
  Affected products

Affected Products

1. PIPELINE FLEX EMBOLIZATION DEVICE
2. Pipeline Flex Embolization Device with Shield Technology

Reason

Medtronic is providing this notice regarding a labeling update to ensure awareness among users, which describes the existing risks and potential patient harms associated with separation or fracture. This labeling change further clarifies certain conditions where the risk of separation may be increased, such as under conditions of increased vessel tortuosity and/or excessive resistance during advancement or retraction of the device.

The Instructions For Use (IFU) device already contains warnings and cautions related to potential of fracture or separation. Medtronic will be supplementing the Instructions For Use with further updates to one of the precaution and warning statements and the device complications section.

Affected products