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Xps system-blades
Official notice
1 Sept 2021
Last checked
1 Sept 2021
An official Health Canada notice concerns Xps system-blades. Medtronic is voluntarily recalling specific lot numbers of sterile blade single-use accessories. Navigation blades are being used to aid in accuracy during the procedure, and if they wobble, that accuracy and precision is diminished. Medtronic has received complaints related to tip breaks and wobble/vibration in this subset of devices. Tip breaks or detachment of fragments may cause harm to the patient, cause lack of oxygenation or foreign body reaction if the fragment were to migrate into the patient's airway or be irretrievable. There is also a chance that the tip may impact critical structures such as nerves and arteries. Blade wobble or vibration may also lead to permanent damage if it causes the blade to impact critical structures. Recall start date: August 16, 2021 Published 2021-09-01.
What to do now
Contact the manufacturer if you require additional information.
Recall number
64448
Official notice
2021-09-01
The hazard
The hazard
Medtronic is voluntarily recalling specific lot numbers of sterile blade single-use accessories. Navigation blades are being used to aid in accuracy during the procedure, and if they wobble, that accuracy and precision is diminished. Medtronic has received complaints related to tip breaks and wobble/vibration in this subset of devices. Tip breaks or detachment of fragments may cause harm to the patient, cause lack of oxygenation or foreign body reaction if the fragment were to migrate into the patient's airway or be irretrievable. There is also a chance that the tip may impact critical structures such as nerves and arteries. Blade wobble or vibration may also lead to permanent damage if it causes the blade to impact critical structures. Recall start date: August 16, 2021
How to check if you're affected
How to check if you're affected
Compare the product name and identifiers below with the item you own. Follow the official notice if they match.
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Where it was sold
Where it was sold
The source does not list specific retailers. See the official notice for where affected products were sold.
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Affected area 1
Company & contacts
Company & contacts
Brand: Medtronic Xomed, Xps System-blades.
Source & status
Source & status
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Recall details
Recall details
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Documents, notices & source
See the official notice and source documents for full details.
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