FDA Device recall Z-0827-2025
VISIONIST CRT-P, EL (Model Number U225 and U226) and EL MRI (Model Number U228)
- FDA Device
- Class I
- ongoing
- Published 2025-01-22
On 2025-01-22 the FDA classified a Class I recall of VISIONIST CRT-P, EL (Model Number U225 and U226) and EL MRI (Model Number U228) by Boston Scientific, citing A subset of devices from the ACCOLADE Family of Pacemakers and CRT-Ps, built before September 2018, have an increased potential to initiate Safety Mode during telemetry or other n….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0827-2025 |
| Classification | Class I |
| Status | ongoing |
| Initiated | 2024-12-12 |
| Published | 2025-01-22 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Boston Scientific |
| Distribution | US |
Product
VISIONIST CRT-P, EL (Model Number U225 and U226) and EL MRI (Model Number U228)
Reason
A subset of devices from the ACCOLADE Family of Pacemakers and CRT-Ps, built before September 2018, have an increased potential to initiate Safety Mode during telemetry or other normal, higher-power operations due to latent high battery impedance.
Identifiers
| code_info | U225 - UDI-DI: 00802526559433, 00802526577116, 00802526577048, 00802526578809, Serial Numbers: 100320 100321 100388 100…U225 - UDI-DI: 00802526559433, 00802526577116, 00802526577048, 00802526578809, Serial Numbers: 100320 100321 100388 100543 100545 100712 100717 100720 100734 100747 100787 100800 100804 100806 100807 100810 100819 100827 100828 100832 100834 100835 100845 100849 100850 100851 100852 100853 100856 100858 100865 100874 100879 100880 100887 100888 100889 100890 100892 100894 100895 100900 100901 100902 100905 100906 100907 100908 100913 100915 100916 100917 100919 100921 100922 100923 100924 100926 100928 100929 100930 100931 100932 100933 100934 700015 700016 700035 700039 700040 700043 700044 700047 700048 700052 700056 700060 700063 700064 700067 700071 700072 700075 700077 700080 700082 700084 700085 700088 700089 700092 700094 700099 700100 700102 700103 700104 700105 700108 700109 700110 700115 700121 700125 700128 700132 700134 700145 700148 700153 700160 700165 700170 700180 700188 700189 700246 700249 700268 700271 700274 700278 700279 700281 700285 700288 700291 700292 700296 70 |
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Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0827-2025%22
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