Database updated: 27 October 2026

Safety Information

Medsafe Online Recall Database

Detail of Recall

Type of Product:Device
Medsafe Reference:19898
Brand Name:Stryker Neurovascular - III - 46352 - Neurovascular embolisation implant
Model:
Affected:
Software version:
Recalling Organisation:Stryker New Zealand Ltd
515 Mount Wellington Highway
Mount Wellington
AUCKLAND 1060
Contact Information:0800 787 9287
Manufacturer:Stryker Neurovascular
Issue:It was identified that the Neuroform Atlas pouch and carton label references the incorrect measurement in millimeters for the Minimum Catheter Diameter. The Minimum Catheter Diameter is correctly listed as 0.0165 inches on both product labels, but incorrectly converted to millimetres as 0.69mm. The correct conversion value is 0.42. The labelling discrepancy could lead to a physician selecting a catheter which is too large. The hazard associated with this is that the stent would prematurely deploy during transfer into the catheter. The result to the patient being extended procedure/ additional treatment required and increased time under anaesthesia. No adverse health consequences are anticipated. There is no risk to patients associated with previous use of affected devices.
Recall action type:Alert
Recall action:Manufacturer to issue advice regarding use
Level of recall:Hospital/Pharmacy/Laboratory
Date Commenced:18/3/2016
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