Boston Scientific Maestro 4000 Cardiac Ablation System, Firmware Version 5.14, Model Numbers: M00440000, M0044000D0, M0044000H0,M0044000R0, M0044000Z0,
Reported: October 31, 2018 Initiated: June 20, 2018 #Z-0202-2019
Product Description
Boston Scientific Maestro 4000 Cardiac Ablation System, Firmware Version 5.14, Model Numbers: M00440000, M0044000D0, M0044000H0,M0044000R0, M0044000Z0,
Reason for Recall
Reports of unintended continuation of radiofrequency (RF) energy delivery from the Cardiac ablation system after the foot switch has been released.
Details
- Recalling Firm
- Boston Scientific Corporation
- Units 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 (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
- Location
- Marlborough, MA
Frequently Asked Questions
What product was recalled? ▼
Boston Scientific Maestro 4000 Cardiac Ablation System, Firmware Version 5.14, Model Numbers: M00440000, M0044000D0, M0044000H0,M0044000R0, M0044000Z0,. Recalled by Boston Scientific Corporation. Units affected: 793.
Why was this product recalled? ▼
Reports of unintended continuation of radiofrequency (RF) energy delivery from the Cardiac ablation system after the foot switch has been released.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on October 31, 2018. Severity: Moderate. Recall number: Z-0202-2019.
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