Boston Scientific Corporation: Medical Device Recall in 2018 - (Recall #: Z-0202-2019)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2018.

Data Source: FDA.

Product Description:

Boston Scientific Maestro 4000 Cardiac Ablation System, Firmware Version 5.14, Model Numbers: M00440000, M0044000D0, M0044000H0,M0044000R0, M0044000Z0,

Product Classification:

Class II

Date Initiated: June 20, 2018

Date Posted: October 31, 2018

Recall Number: Z-0202-2019

Event ID: 80501

Reason for Recall:

Reports of unintended continuation of radiofrequency (RF) energy delivery from the Cardiac ablation system after the foot switch has been released.

Status: Ongoing

Product Quantity: 793

Code Information:

All Maestro 4000 Generators used with the optional foot switch.

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

Voluntary or Mandated:

Voluntary: Firm initiated