FDA Medical devices recall ·
VISIONIST CRT-P, EL (Model Number U225 and U226) and EL MRI (Model Number… recall
This is an FDA Class I recall — the most serious type.
- Recall number
- Z-0827-2025
- Date
- (initiated December 12, 2024)
- Company / brand
- Boston Scientific Corporation
4100 Hamline Ave N, Saint Paul, MN, United States - Category
- Medical devices › Class I
- Classification
- Class I
- Status
- Ongoing
- Units affected
- 156,329 units (59,937 US, 96,792 OUS) in total
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
VISIONIST CRT-P, EL (Model Number U225 and U226) and EL MRI (Model Number U228)
Why was it recalled?
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.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
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 700297 700298 700301 700302 700303 700304 700305 700308 700309 700310 700311 700313 700314 700315 700323 700324 700327 700328 700329 700330 700331 700332 700333 700334 700336 700337 700338 700339 700341 700342 700343 700346 700348 700349 700350 700352 700353 700354 700355 700356 700357 700361 700362 700363 700364 700365 700367 700368 700370 700371 700372 700374 700375 700376 700377 700378 700379 700381 700382 700383 700384 700386 700387 700388 700391 700392 700393 700394 700396 700397 700398 70040
Distribution
US (Nationwide) including Puerto Rico and US Virgin Islands and OUS (foreign) to countries of: Guam and Northern Mariana Islands.
States: Puerto Rico
What does Class I mean?
Class I is the most serious FDA recall class: there is a reasonable probability that using or being exposed to the product will cause serious adverse health consequences or death.
Source: FDA (medical devices), recall Z-0827-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.