Recall Z-0826-2025— Boston Scientific Corporation
Class I · Ongoing
Class I FDA medical device recall by Boston Scientific Corporation, initiated 2024-12-12. FDA's recall record names no specific 510(k) clearance for this event. Product: VALITUDE CRT-P, EL (Model Number U125) and EL MRI (Model Number U128). 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..
- Recalling firm
- Boston Scientific Corporation
- Classification
- Class I
- Status
- Ongoing
- Initiated
- 2024-12-12
- Firm location
- Saint Paul, MN, United States
Product description
VALITUDE CRT-P, EL (Model Number U125) and EL MRI (Model Number U128)
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.