NC Trek RX Coronary Dilatation Catheter (2020-01-29)

Starting date:

January 29, 2020

Posting date:

February 4, 2020

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-72273

Last updated: 2020-02-04

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  Reason
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  Affected products

Affected Products

NC Trek RX Coronary Dilatation Catheter

Reason

Devices from the identified lots may exhibit difficulty or inability to deflate the balloon due to weaker material proximal to the balloon bond resulting from excess heat exposure during manufacturing. The reported frequency of difficulty or inability to deflate the balloon for the affected population of lots is 0.09%.

Affected products