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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

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

NC Sprinter Rx Balloon Catheter

Lot or serial number
  • 207002011
Model or catalog number
  • NCSP22512X
Companies
Manufacturer
Medtronic Inc.
710 Medtronic Parkway NE
Minneapolis
55432
Minnesota
UNITED STATES