Z-2143-2020 Class II Terminated
FDA device recall Z-2143-2020 was initiated by Spectranetics Corporation on March 31, 2020 and is designated Class II. Reason for recall: There is a potential for thrombus formation on balloons prepped and staged in the vasculature for long durations. All users, such as those performing lead extraction cases may not be aware of this ri… The recall status is terminated (terminated October 31, 2022). Affected quantity: N/A.
Recall Details
- Product Type
- Devices
- Report Date
- June 3, 2020
- Initiation Date
- March 31, 2020
- Termination Date
- October 31, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- N/A
Product Description
Reason for Recall
Distribution Pattern
US: Nationwide OUS: Australia, Austria, Belgium, Canada, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Israel, Italy, Japan, Jordan, Latvia, Liechtenstein, Lithuania, Luxembourg, Malta, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, The Netherlands, and the United Kingdom of Great Britain and Northern Ireland