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Delivery Catheter System with Accutrak Stability Layer (2013-11-21)
- Starting date:
- November 26, 2013
- Posting date:
- January 6, 2014
- 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-37277
Recalled products
- Delivery Catheter System with Accutrak Stability Layer
Reason
This notification is to inform about practices to avoid nose cone separations from the distal end of the catheter on the corevalvet accutrakt delivery catheter system (DCS). To reduce the occurrence of nose cone separations, Medtronic is modifying the instructions for use (IFU) and training materials.
Affected products
A. Delivery Catheter System with Accutrak Stability Layer
Lot or serial number
- All lots
Model or catalog number
- DCS-C4-18FR
Companies
- Manufacturer
-
Medtronic Corevalve LLC
1851 East Deere Ave.
Santa Ana
92705
California
UNITED STATES