Boston Scientific Maestro 4000 Cardiac Ablation System, Firmware Version 5.14, Model Numbers: M00440000, M0044000D0, M00

FDA device recall Z-0202-2019 · posted 2018-08-28 · Open, Classified

Recall details

Recalling firm

Boston Scientific Corporation

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 taken

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.

Status

Open, Classified

Product code

OAD

Quantity affected

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 (OU

Date initiated

2018-06-20

Date posted

2018-08-28

Location

Marlborough, MA