International safety notice

As a result of an investigation by an overseas manufacturer, a special It was discovered that burrs may not have been properly removed during the molding process of a certain lot of nylon resin (raw material). I did. It may cause injury. We will implement it.

Japan / PMDA Recalls · JPN · Jun 3, 2021

Key facts

Title As a result of an investigation by an overseas manufacturer, a special It was discovered that burrs may not have been properly removed during the molding process of a certain lot of nylon resin (raw material). I did. It may cause injury. We will implement it.
Regulator Japan / PMDA Recalls
Country JPN
Brand Common name: Brain electrical stimulation device for shaking Sales name: DBS Lead
Manufacturer Japan Medtronic Co., Ltd.
Models VA2CN86, VA2CNXG, VA22KF4, VA2CN0H, VA25LHE, VA254MD, VA29BSM, VA21ZL1, VA28M22, VA27WDE, VA27ZRE, VA28KWJ and 42 more
Date Jun 3, 2021
Regulator page info.pmda.go.jp

At a glance

  • No Recall
  • No Field safety notice

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