Recalls and alerts more than 4 years old are automatically archived. While this information can still be accessed in the database, it has not been altered or updated since it was archived. Web pages that are archived on the Web are not subject to the Government of Canada Web Standards. As per the Communications Policy of the Government of Canada, you can request alternate formats by contacting us.

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

Report a Concern
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