Maastricht-Airport, Netherlands
CardioTek BV recalls
1 recall recorded since 2018, most recently on 25 April 2022. None are listed as ongoing. Status and classification are as published by the FDA.
Recalls1
Ongoing (FDA)0
Terminated or completed1
Class I (FDA)0
Completed Class II Medical devices
- Recall started
- 25 April 2022
- Reason
- Device did not pass electrical safety testing for adequate insulation.
- Distribution
- Worldwide distribution - US Nationwide distribution in the states of CA, NY, NC and the countries of South Korea, Mexico, Kazakhstan, Netherlands, Spain, Germany, Finland, Poland, Israel, Turkey, Chile, Ecuador, Austria, Croatia, Sweden, United Kingdom, Colombia, Italy, Portugal, Canada, Saudi Arabi
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1283-2022
- CardioTek EP-TRACER Software V2.x.
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.