International safety notice

General names: (1), (2) Intravascular catheters for non-central circulatory occlusion, (3) Catheter for removal of non-central circulatory emboli Sales name: (1)Remate Irrigation Occlusion Catheter (2)Remate Small Occlusion Catheter (3) Over-the-wire thrombectomy catheter

Japan / PMDA Recalls · JPN · May 1, 2025

Key facts

Regulator Japan / PMDA Recalls
Country JPN
Brand General names: (1), (2) Intravascular catheters for non-central circulatory occlusion, (3) Catheter for removal of non-central circulatory emboli Sales name: (1)Remate Irrigation Occlusion Catheter (2)Remate Small Occlusion Catheter (3) Over-the-wire thrombectomy catheter
Manufacturer Remate Vascular LLC
Models POC2028, OTW4375, XOT1310, OTW4911, OTW00004972, OTW4504A, OTW4520, POC1909, POC2018, OTW4602, PIO1475, XOT00001974 and 350 more
Date May 1, 2025
Regulator page info.pmda.go.jp

At a glance

  • No Recall
  • No Field safety notice
  • 1–9 Matching device models in FDA data

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

About International device safety notices

Field safety notices, recalls and safety alerts published by about 30 national medical device regulators outside the United States, matched by Orca1 to FDA device data.

Source: National medical device regulators (as listed), compiled by Orca1

Browse all International device safety notices