[Recalled] Suction Instruments — Medtronic has become aware that the specific lots of suction instruments are no… | Health Canada 2017-09-05

A safety authority has issued a recall or warning for this item. The confirmed facts from the source notice are laid out below.

Recall details

Why it was recalled

According to the Health Canada — Medical Devices notice, the identified hazard is: 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.

This recall concerns Medical devices products distributed in Canada and was recorded by Health Canada — Medical Devices. Recalls in this category are published so that owners, retailers, and importers can identify affected units and act quickly.

What to do if you own this product

Review the official notice to confirm whether your unit is affected.

Read the full official notice →

This page indexes a public government recall notice for reference. We do not sell or verify this product; always confirm the current status on the authority's official site.