Boston Scientific Maestro 4000 Cardiac Ablation System — Class II medical device recall Z-0202-2019
Ongoing recall by Boston Scientific Corporation, reported 2018-10-31, distributed in AL, AR, AZ, CA, CO, CT, DC, DE…. Reports of unintended continuation of radiofrequency (RF) energy delivery from the Cardiac ablation system aft
| Recall number | Z-0202-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Boston Scientific Corporation, Marlborough, MA, United States |
| Recall initiated | 2018-06-20 |
| Classified | 2018-10-22 |
| Reported by FDA | 2018-10-31 |
| Distributed | AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, GU, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, NE, NH, NJ, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV |
| Countries outside the US | AR, AT, AU, BD, BE, BG, CA, CH, CL, CN, CO, CZ, DE, DK, ES, FI, FR, GB, GR, HU, IE, IL, IR, IT, JO, JP, KW, LB, LK, LT, MX, MY, NI, NL, PA, PH, PK, PL, PT, SA, SE, TH, TR, TW, VN, ZA |
| Quantity | 793 |
| Model numbers | M00440000, M0044000D0, M0044000H0, M0044000R0, M0044000Z0 |
Product
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0202-2019. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.