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Suction Instruments
- Starting date:
- July 12, 2017
- Posting date:
- September 5, 2017
- 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-64344
Reason
Medtronic has become aware that the specific lots of suction instruments are not able to pass instrument verification. Instrument verification is a step in the software which is performed prior to the use of each instrument. This verification step confirms device tracking functionality and prevents use of the device if a passing verification is not achieved. The impacted devices were made with a particular stainless steel stock material that exhibits magnetic characteristics (magnetic permeability), causing interference with electromagnetic (EM) tracking capability of the StealthStation.
If this issue presents during surgery, it may result in surgery being extended to troubleshoot the issue, discontinuation of navigation, or aborting surgery if alternative instruments are not available to proceed. There have been no reports of patient injury.
Affected products
Suction Instruments
Lot or serial number
16062713
Model or catalog number
9734308
Companies
- Manufacturer
-
Medtronic Navigation Inc.
826 Coal Creek Circle
Louisville
80027
Colorado
UNITED STATES