Direxion And Direxion Hi-flo Intravascular Microflow Catheter

Recall Summary Direxion and Direxion HI-FLO microcatheters (medical devices used in blood vessels) are being recalled due to a manufacturing defect that can make them difficult to insert, remove, or withdraw through guide catheters. The problem causes increased resistance during use and may damage the device, potentially leading to complications such as vessel injury, blood clots, or fragments left in the patient. The recall affects multiple batches distributed to hospitals and pharmacies in New Zealand.

Recalling firm

Boston Scientific NZ Ltd

Product

Direxion and Direxion HI-FLO Intravascular microflow catheter. [Device]. Model: Direxion and Direxion HI-FLO. Affected: Multiple batches

Reason

The manufacturer is initiating the removal of specific lots of DirexionTM and Direxion HIFLOTM Microcatheters due to a manufacturing issue that may cause difficulty withdrawing the device from the carrier hoop and difficulty advancing or withdrawing the device through a guide catheter., The problem is detectable during device preparation and/or use in the patient and is experienced as increased resistance between the microcatheter and other components. This increased resistance, including attempts to advance or withdraw the device when resistance is encountered, may result in damage to...

Classification

Class I

Category

medical device recall

Country

New Zealand

Agency

MEDSAFE

Recall date

2026-09-16

Status

Ongoing

Distribution

New Zealand - Hospital/Pharmacy/Laboratory

Official recall notice from MEDSAFE

Recall details on Nibble Recalls: https://trynibble.app/recalls/ffc70070-9814-4df3-ac96-31ace9b04856