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Solarice Rapid Exchange Balloon Dilation Catheter
- Starting date:
- July 13, 2017
- Posting date:
- August 15, 2017
- 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-64224
Reason
Medtronic is initiating a voluntary recall on specific lots of Solarice Rapid Exchange Balloon Dilation Catheter due to reports of stylette removal difficulties. In the event that stylette removal difficulties are encountered, there is the potential for damage to the balloon or catheter due to excessive force being applied, and this may lead to balloon inflation or deflation challenges. Potential risks associated with balloon inflation and deflation difficulties include prolonged procedure time and the need for additional intervention. In addition, inflation or deflation difficulties or catheter damage during procedural use could result in vessel occlusion or injury.
Affected products
Solarice Rapid Exchange Balloon Dilation Catheter
Lot or serial number
212266542
212955158
213151478
Model or catalog number
SLC2012X
SLC2015X
SLC27515X
Companies
- Manufacturer
-
Medtronic Inc.
710 Medtronic Parkway NE
Minneapolis
55432
Minnesota
UNITED STATES