Class 2 Device Recall Maestro 4000 Cardiac Ablation System

• Date Initiated by Firm: June 20, 2018
• Date Posted: August 28, 2018
• Recall Status: Open, Classified
• Recall Number: Z-0202-2019
• Recall Event ID: 80501
• PMA Number: P020025 P920047 P980003
• Product Classification: catheter, percutaneous, cardiac ablation, for treatment - Product Code OAD
• Product: Boston Scientific Maestro 4000 Cardiac Ablation System, Firmware Version 5.14, Model Numbers: M00440000, M0044000D0, M0044000H0,M0044000R0, M0044000Z0,
• Code Information: All Maestro 4000 Generators used with the optional foot switch.
• Recalling Firm/ Manufacturer: Boston Scientific Corporation; 100 Boston Scientific Way; Marlborough MA 01752-1234
• For Additional Information Contact: Nicole Pshon; 763-494-1133
• Manufacturer Reason for Recall: Reports of unintended continuation of radiofrequency (RF) energy delivery from the Cardiac ablation system after the foot switch has been released.
• Action: On 06/20/2018, a system notice was sent to customers, informing them that releasing the foot switch may not stop RF delivery. If RF delivery does not stop as intended, press and release the RF Power Control button. Customers were advised to report occurrence and clinical outcome of unintended RF delivery to the firm:United States (1-800-949-6708), Europe, Middle East, and Africa (+800-5555-7707), Asia Pacific (+65-6418-8878). Notification outside of the U.S. started 06/21/18. On 09/20/2019, a System Correction Notice was sent to Cath/EP Lab Managers informing them that the firm will begin the process of upgrading the firmware of affected cardiac ablation systems. The firmware update will eliminate one potential cause of this behavior. Residual risks for other potential causes of RF termination delay remain. Cath/EP Lab Managers were asked to distribute the notice within their respective facilities, continue to post a copy of Appendix A of the June 2018 notice near each affected system, allow the recalling firm to access affected systems for the firmware update, and to complete, sign, and return the acknowledgement form.
• Quantity in Commerce: 793
• Distribution: 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
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• PMA Database: PMAs with Product Code = OAD and Original Applicant = BOSTON SCIENTIFIC; PMAs with Product Code = OAD and Original Applicant = Boston Scientific Corp.