Solarice Rapid Exchange Balloon Dilation Catheter (2019-09-04)

Starting date:

September 4, 2019

Posting date:

October 3, 2019

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-71133

Last updated: 2019-10-03

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  Reason
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  Affected products

Affected Products

Solarice Rapid Exchange Balloon Dilation Catheter

Reason

Medtronic has determined that some catheters have a slightly higher diameter stylette causing removal difficulties. If 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 injury.

Affected products