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Semislip Guidewire
- Starting date:
- November 30, 2016
- Posting date:
- December 16, 2016
- 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-61466
Reason
Because of a lack in strength of the material, there is a potential for the hydrophilic-coated Pebax tip to loosen from the core of the guidewire which could result in some fragments of the tip of the guidewire to become loose and stay in the body of the patient. This would require surgery to remove the parts of the guidewire from the body. This problem occurred only once in a hospital in Kufstein, Austria.
Affected products
Semislip Guidewire
Lot or serial number
- C15-4089
- G4905791
- G4918166
Model or catalog number
- UAS-35150-S
Companies
- Manufacturer
-
UROTECH GmbH
MEDI-GLOBE-STRASSE 1-5
ACHENMUHLE
68305
GERMANY