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Endurant iis stent graft system
Official notice
17 Jan 2022
Last checked
17 Jan 2022
An official Health Canada notice concerns Endurant iis stent graft system. Devices built with specific batches of taper tip assemblies have the potential for the taper tip to detach from the delivery system. Detachment of the taper tip during the implant procedure may lead to a secondary intervention to attempt to remove the taper tip, either by endovascular retrieval or surgical conversion. There is also potential that the taper tip is intentionally left behind in the patient, at the physician's discretion, if not easily removable. As of 09-Dec-2021, Medtronic has received five (5) complaints where the taper tip detached from the delivery system during the procedure. In three (3) cases the tip was retrieved successfully: One (1) through surgical conversion and two (2) by snaring. In the remaining two (2) cases the tip was intentionally left behind. No deaths have been reported from the five (5) complaints. Recall start date: Dec 23, 2021 Published 2022-01-17.
What to do now
Contact the manufacturer if you require additional information.
Recall number
63821
Official notice
2022-01-17
The hazard
The hazard
Devices built with specific batches of taper tip assemblies have the potential for the taper tip to detach from the delivery system. Detachment of the taper tip during the implant procedure may lead to a secondary intervention to attempt to remove the taper tip, either by endovascular retrieval or surgical conversion. There is also potential that the taper tip is intentionally left behind in the patient, at the physician's discretion, if not easily removable. As of 09-Dec-2021, Medtronic has received five (5) complaints where the taper tip detached from the delivery system during the procedure. In three (3) cases the tip was retrieved successfully: One (1) through surgical conversion and two (2) by snaring. In the remaining two (2) cases the tip was intentionally left behind. No deaths have been reported from the five (5) complaints. Recall start date: Dec 23, 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
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Company & contacts
Company & contacts
Brand: Medtronic, Endurant Iis Stent Graft System.
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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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