Recall Z-0202-2019 ยท OAD Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter
Boston Scientific Corporation
Boston Scientific Maestro 4000 Cardiac Ablation System, Firmware Version 5.14, Model Numbers: M00440000, M0044000D0, M0044000H0,M0044000R0, M0044000Z0,
| Date | Aug 28, 2018 (initiated Jun 20, 2018) |
| Status | Open, Classified |
| Reason | 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 |
| Quantity | 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, |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.