NC Sprinter Rx Balloon Catheter (2013-09-16)

Starting date:

September 16, 2013

Posting date:

October 16, 2013

Type of communication:

Medical Device Recall

Subcategory:

Medical Device

Hazard classification:

Type III

Source of recall:

Health Canada

Issue:

Medical Devices

Audience:

General Public, Healthcare Professionals, Hospitals

Identification number:

RA-36229

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  Reason
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  Affected products

Recalled Products

NC Sprinter Rx Balloon Catheter

Reason

Medtronic initiated a medical device recall of the NC sprinter Rx balloon dilatation catheter, Model NCSP22512X. Medtronic has identified a labeling issue relating to lot number 207002011 in which the compliance chart contained inside the package incorrectly references a 2.5 mm balloon diameter instead of the correct 2.25 mm diameter. As a result, Medtronic is requesting the return of the affected lot of NC Sprinter Rx balloon dilatation catheters.

Affected products