Recall Z-0827-2025
Boston Scientific Corporation · initiated December 12, 2024
Class I – dangerous or defective products that could cause serious health problems or death
Product
VISIONIST CRT-P, EL (Model Number U225 and U226) and EL MRI (Model Number U228)
Codes / lots: 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…
Reason for recall
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.
FDA-determined cause: Process design
Action taken
The firm sent an "URGENT MEDICAL DEVICE INFORMATION" letter dated December 2024. The letter describes the product, problem and actions to be taken. The customers were instructed to promptly identify patients, if device enters Safety Mode, perform emergent replacement for patients who are at risk for harm, during replacement of a device in Safety Mode pacing inhibition should be anticipated during electrocautery. General prophylactic replacement is not recommended; schedule device replacement promptly when the longevity remaining reaches four (4) years or if the longevity remaining is less than 4 years, perform system follow-ups in accordance with the instructions for use and update patients records with letter to maintain awareness for the remaining service life of the device. If you have any questions regarding this information or would like to report a clinical event, contact your Boston Scientific representative or Technical Services. Supplement March 26, 2025, High-Level Overview of Recall Strategy: on 03/26/2025, BSC notified only those implanting and following clinicians responsible for the newly identified active advisory devices. The letter sent to these clinicians will be the original December 12, 2024, Product Advisory letter, however, the March 2025 communication included a cover letter stating that new devices were identified that should have been initially categorized in the Advisory population.
Details
- Recall number
- Z-0827-2025
- Initiated
- December 12, 2024
- Posted by FDA
- January 10, 2025
- Product code
- NKE – Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P)
- Quantity
- 156,329 units (59,937 US, 96,792 OUS) in total
- Distribution
- US (Nationwide) including Puerto Rico and US Virgin Islands and OUS (foreign) to countries of: Guam and Northern Mariana Islands.
- Recalling firm
- Boston Scientific Corporation, Saint Paul, MN
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-0822-2025 Class I | ACCOLADE DR Pacemaker, SL (Model Number L301), SL MRI (Model Number L311), EL (Model…A subset of devices from the ACCOLADE Family of Pacemakers and CRT-Ps, built before September 2018, have an… | 12/12/2024Open, Classified |
| Z-0823-2025 Class I | PROPONENT DR Pacemaker, SL (Model Number L201), (VDD) SL (Model Number L209), SL MRI…A subset of devices from the ACCOLADE Family of Pacemakers and CRT-Ps, built before September 2018, have an… | 12/12/2024Open, Classified |
| Z-0824-2025 Class I | ESSENTIO DR Pacemaker, SL (Model Number L101, SL MRI (Model Number L111), EL (Model…A subset of devices from the ACCOLADE Family of Pacemakers and CRT-Ps, built before September 2018, have an… | 12/12/2024Open, Classified |
| Z-0825-2025 Class I | ALTRUA 2 DR Pacemaker, SL (Model Number S702) and EL (Model Number S722)A subset of devices from the ACCOLADE Family of Pacemakers and CRT-Ps, built before September 2018, have an… | 12/12/2024Open, Classified |
| Z-0826-2025 Class I | VALITUDE CRT-P, EL (Model Number U125) and EL MRI (Model Number U128)A subset of devices from the ACCOLADE Family of Pacemakers and CRT-Ps, built before September 2018, have an… | 12/12/2024Open, Classified |