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Various Micro Therapeutics Inc. catheters and devices (2016-10-18)
- Starting date:
- October 18, 2016
- Posting date:
- November 7, 2016
- 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-60914
Affected Products
- ALLIGATOR RETRIEVAL DEVICE
- X-CELERATOR EXCHANGE HYDROPHILIC GUIDEWIRE - SS
- ULTRAFLOW HPC FLOW DIRECTED MICRO CATHETER
- MARATHON FLOW DIRECTED MICRO CATHETER
- PIPELINE EMBOLIZATION DEVICE (25-35MM)
Reason
Medtronic has identified the potential for an issue with a specific set of lot numbers where the PTFE (polytetrafluoroethylene) coating could delaminate and separate from the delivery wire. Delamination and detachment of the PTFE coating material may lead to PTFE coating in the blood stream. PTFE in the blood stream, based on its specific size and quantity, may be safe or could lead to thromboembolic complications or irreversible injuries including but not limited to: intracranial edema, peripheral edema, incomplete treatment, infection, local inflammatory response, systemic inflammatory response, ischemic stroke, lysis/necrosis, neurological deficit, organ impairment, shock, space occupying lesion, thrombosis, and hemorrhage.
Through September 27, 2016, Medtronic has received a total of five (5) reports for the products that are potentially affected by this issue. Medtronic has received no reports of serious injuries or patient death as a result of this issue.
Affected products
A. ALLIGATOR RETRIEVAL DEVICE
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
- FA-88810-20
- FA-88810-30
- FA-88810-40
- FA-88810-50
Companies
- Manufacturer
-
Micro Therapeutics Inc.
DBA EV3 Neurovascular
9775 Toledo Way
Irvine
92618
UNITED STATES
B. X-CELERATOR EXCHANGE HYDROPHILIC GUIDEWIRE - SS
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
- 103-0601-300
- 103-0602-300
Companies
- Manufacturer
-
Micro Therapeutics Inc.
DBA EV3 Neurovascular
9775 Toledo Way
Irvine
92618
UNITED STATES
C. ULTRAFLOW HPC FLOW DIRECTED MICRO CATHETER
Lot or serial number
- A072386
- A092709
- A126396
- A127019
- A091993
- A091996
- 9972750
- A020842
- A025090
- A044668
Model or catalog number
- 105-5065
Companies
- Manufacturer
-
Micro Therapeutics Inc.
DBA EV3 Neurovascular
9775 Toledo Way
Irvine
92618
UNITED STATES
D. MARATHON FLOW DIRECTED MICRO CATHETER
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
- 105-5055
Companies
- Manufacturer
-
Micro Therapeutics Inc.
DBA EV3 Neurovascular
9775 Toledo Way
Irvine
92618
UNITED STATES
E. PIPELINE EMBOLIZATION DEVICE (25-35MM)
Lot or serial number
- A090167
- A090181
- A090209
- A104383
- A104400
- A104409
- A110383
- A110389
Model or catalog number
- FA-71375-25
- FA-71400-25
- FA-71425-25
- FA-71450-25
- FA-71475-25
- FA-71500-25
Companies
- Manufacturer
-
Micro Therapeutics Inc.
DBA EV3 Neurovascular
9775 Toledo Way
Irvine
92618
UNITED STATES