Z-0202-2019 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- October 31, 2018
- Initiation Date
- June 20, 2018
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 793
Product Description
Boston Scientific Maestro 4000 Cardiac Ablation System, Firmware Version 5.14, Model Numbers: M00440000, M0044000D0, M0044000H0,M0044000R0, M0044000Z0,
Reason for Recall
Reports of unintended continuation of radiofrequency (RF) energy delivery from the Cardiac ablation system after the foot switch has been released.
Distribution Pattern
U.S.: PA, IL, NY, CA, SC, AR, SD, AZ, KY, FL, TX, MA, MI, OH, LA, VA, NC, WA, DE, IN, TN, NJ, CT, AL, ME, GA, NH, MN, MD, DC, OK, HI, WI, CO, MO, IA, GU, NE, OR, ID, UT, RI, KS, NV, MS, WV Foreign (OUS): Canada, Albania, Austria, Belgium, Bulgaria, Czech Republic, Denmark, Finland, France, Germany, Great Britain, Greece, Hungary, Iran, Ireland, Israel, Italy, Jordan, Kuwait, Lithuania, Namibia, Netherlands, Lebanon, Pakistan, Poland, Portugal, Russian Fed., Saudi Arabia, South Africa, Spain, Sudan, Sweden, Switzerland, Turkey, Unit.Arab Emir., Argentina, Australia, Bangladesh, Chile, China, Colombia, Japan, Malaysia, Mexico, Nicaragua, Panama, Philippines, Sri Lanka, Taiwan, Thailand, Vietnam
Code Information
All Maestro 4000 Generators used with the optional foot switch.