ProACT Implantation Instrument Set, is a reusable, steam sterilizable surgical instrument set consisting of a U-Channel Sheath through which the Pro ACT balloon implant is introduced.
Potential issue with the manufacture and inspection of U-channel sheaths in Implantation Instruments Sets. Affected U-channel sheaths may be more likely to cause damage to ProACT implant devices when passes through the sheaths.
Nationwide distribution to the following states: CA, GA, FL, MI, and VA.
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1808-2020