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Galeo Pro Coronary Guidewire
- Starting date:
- November 15, 2016
- Posting date:
- November 15, 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-61068
Affected Products
Reason
This voluntary recall is being conducted due to the potential separation and detachment of the polytetrafluoroethylene (PTFE) coating on parts of these devices. Should the PTFE separate from the coronary guidewire, PTFE particulate could enter the blood stream of the patient.
Affected products
Galeo Pro Coronary Guidewire
Lot or serial number
More than 100 numbers, contact the manufacturer.
Model or catalog number
- 389781
- 389782
- 389783
- 389784
- 389785
- 389786
- 389787
- 389788
- 389791
Companies
- Manufacturer
-
Concert Medical LLC
77 Accord Park Dr.
Norwell
02061
Massachusetts
UNITED STATES