Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 29384 |
| Brand Name: | MITG - Trocar sleeve (Class IIA) |
| Model: | EEA25, EEAXL25, EEA2535, EEAXL2535 |
| Affected: | All Lots beginning with "P0", "P1", "P7", "P8", "P9" |
| Software version: | |
| Recalling Organisation: | Medtronic New Zealand Limited Unit 16 Mezzanine Level 5 Gloucester Park Road Onehunga AUCKLAND |
| Contact Information: | 0800 377 807 |
| Manufacturer: | Covidien LLC |
| Issue: | Distributed 25mm EEA Autosuture Circular Staplers with DST Series Technology, with model numbers EEA25, EEAXL25, EEA2535, and EEAXL2535, have the potential for the staple guide to not be securely attached to the instrument. This issue is related only to the 25mm EEA Autosuture Circular Staplers with DST Series Technology. No other Medtronic products or other sizes of EEA Autosuture Circular Staplers with DST Series Technology are affected by this issue. Through 04 April 2022, Medtronic has received 23 complaints potentially related to disengaged staple guides, of which two (2) complaints were directly confirmed through investigation of returned product. A staple guide not attached to the instrument could cause the component to disengage and if disengaged, could allow the device to transect tissue without forming staples. This could result in delay of treatment, extended hospital stay, unspecified tissue injury, unintended radiation exposure, unexpected medical intervention and others. |
| Recall action type: | Recall |
| Recall action: | Product to be returned to supplier |
| Level of recall: | Hospital/Pharmacy/Laboratory |
| Date Commenced: | 13/5/2022 |
