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FLEXCATH ADVANCE (2017-10-11)
- Starting date:
- October 11, 2017
- Posting date:
- October 30, 2017
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type II
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- Healthcare Professionals, General Public, Hospitals
- Identification number:
- RA-64992
Affected products
FLEXCATH ADVANCE
Reason
Updates to instructions for use (IFU) manual. This IFU revision incorporates current best practices for minimizing the potential for air ingress and the risk of air embolism. Medtronic has supplemented the IFU to highlight known risk of air embolism more prominently. Medtronic is not retrieving product from the field.
Affected products
FLEXCATH ADVANCE
Lot or serial number
All lots
Model or catalog number
4FC12
Companies
- Manufacturer
-
Medtronic Cryocath LP
9000 AUTOROUTE TRANSCANADIENNE
POINTE-CLAIRE
H9R 5Z8
Quebec
CANADA