Pipeline Flex Embolization Device and Pipeline Flex Embolization Device With Shield Technology (2020-02-18)
- Starting date:
- February 18, 2020
- Posting date:
- March 3, 2020
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type I
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- General Public, Healthcare Professionals, Hospitals
- Identification number:
- RA-72475
Last updated: 2020-03-06
Affected Products
- Pipeline Flex Embolization Device
- Pipeline Flex Embolization Device With Shield Technology
Reason
Medtronic has identified the potential for device fracture at the distal section during use due to a weakened bond in a subset of devices that have been recently manufactured. Use of affected product may result in unintended separation, where the distal portion of the device delivery system remains in the patient. If this occurs, it may result in significant patient injury, including a prolonged procedure, ischemic stroke, intracranial hemorrhage, neurological deficit, and/or death.
Affected products
A. Pipeline Flex Embolization Device
Lot or serial number
- A946808
- A946811
- A946813
- A946815
- A946816
- A946817
- A947151
- A947154
- A947155
Model or catalog number
- PED-325-30
- PED-350-18
- PED-375-10
- PED-375-14
- PED-400-18
- PED-400-20
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
- PED2-325-10
- PED2-325-12
- PED2-325-14
- PED2-325-16
- PED2-350-16
- PED2-375-18
- PED2-375-20
- PED2-400-16
- PED2-400-20
- PED2-400-25
- PED2-425-16
- PED2-450-16
- PED2-450-18
- PED2-450-20
- PED2-450-25
- PED2-475-12
- PED2-475-35
- PED2-500-14
- PED2-500-18
- PED2-500-20
Companies
- Manufacturer
-
Micro Therapeutics Inc.
DBA EV3 Neurovascular
9775 Toledo Way
Irvine
92618
California
UNITED STATES