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Pipeline Embolization Device
- Starting date:
- December 7, 2012
- Posting date:
- December 24, 2012
- 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-25929
Recalled Products
- Pipeline Embolization Device
- Pipeline Embolization Device
Reason
The manufacturer have discovered that deployment difficulties of the device may occur in procedures where the Pipeline Embolization Device (PED) is being delivered in areas of significant tortuosity or restrictive anatomy. If significant resistance is encountered during ped delivery, difficulties in obtaining full disengagement from the capture coil or incomplete expansion of the device may occur.
Affected products
A. Pipeline Embolization Device
Lot or serial number
All Lots.
Model or catalog number
More than 10 Lot numbers, contact manufacturer.
Companies
- Manufacturer
- Covidien Inc.
B. Pipeline Embolization Device
Lot or serial number
All Lots.
Model or catalog number
FA-71500-30
Companies
- Manufacturer
- Covidien Inc.