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Boston Scientific Maestro 4000 Cardiac Ablation System… recallZ-0202-2019 · Boston Scientific Corporation · initiated Jun 20, 2018

Class II Open, Classified All recalls posted in August 2018

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Boston Scientific Corporation or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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

What the company is doing

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.

Recall details

Recall number
Z-0202-2019
Recall class
Class II
Status
Open, Classified
Initiated by the company
Jun 20, 2018
Posted by the FDA
Aug 28, 2018
Recalling firm
Boston Scientific Corporation
Quantity
793
Product code
OAD
FDA submissions
P020025, P920047, P980003
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

Product description

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

Code information (models, lots, serial numbers)

All Maestro 4000 Generators used with the optional foot switch.

Other devices under the same FDA submission

29 devices cleared under P020025, P920047, P980003 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Sources and updates

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