Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 26523 |
| Brand Name: | MITG - Pipeline Shield Embolization Device |
| Model: | |
| Affected: | Pipeline™ Flex Embolization Device and Pipeline™ Flex Embolization Device with Shield Technology |
| Software version: | |
| Recalling Organisation: | Medtronic New Zealand Limited Unit 16 Mezzanine Level 5 Gloucester Park Road Onehunga AUCKLAND |
| Contact Information: | 0800 377 807 |
| Manufacturer: | Micro Therapeutics Inc dba ev3 Neurovascular |
| Issue: | The manufacturer is providing a labelling update to ensure awareness among Pipeline™ Flex and Pipeline™ Flex with Shield Technology™ users, which describes the existing risks and potential patient harms associated with separation or fracture. This labelling change further clarifies certain conditions where the risk of separation may be increased, such as under conditions of increased vessel tortuosity and/or excessive resistance during advancement or retraction of the device. |
| Recall action type: | Correction |
| Recall action: | Instructions for use to be updated |
| Level of recall: | Hospital/Pharmacy/Laboratory |
| Date Commenced: | 8/9/2020 |
