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:

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

A. Pipeline Flex Embolization Device

Lot or serial number
  • A815692
  • A815694
  • A885864
  • A887937
Model or catalog number
  • PED-325-25
  • PED-475-20
  • PED-500-14
Companies
Manufacturer
Micro Therapeutics Inc.
DBA EV3 Neurovascular
9775 Toledo Way
Irvine
92618
California
UNITED STATES

B. Pipeline Flex Embolization Device with Shield Technology

Lot or serial number

More than 10 numbers, contact manufacturer. 

Model or catalog number
  • PED2-250-10
  • PED2-250-14
  • PED2-250-16
  • PED2-275-14
  • PED2-275-16
  • PED2-300-10
  • PED2-300-12
  • PED2-350-20
  • PED2-400-16
  • PED2-400-18
  • PED2-425-10
Companies
Manufacturer
Micro Therapeutics Inc.
DBA EV3 Neurovascular
9775 Toledo Way
Irvine
92618
California
UNITED STATES