FDA Medical devices recall ·
Model Number U125, VALITUDE CRT-P EL recall
This is an FDA Class I recall — the most serious type.
- Recall number
- Z-0101-2026
- Date
- (initiated August 20, 2025)
- 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
- 3620 units
- Hazard tags
- Software
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
Model Number U125, VALITUDE CRT-P EL
Why was it recalled?
Software to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an ambulatory setting due to a high battery impedance state for the ACCOLADE family of devices which includes ACCOLADE, PROPONENT, ESSENTIO, and ALTRUA 2 dual chamber (DR) standard life (SL) and DR extended life (EL) pacemakers; and VISIONIST and VALITUDE cardiac resynchronization therapy pacemakers (CRT-Ps).
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
GTIN 00802526559389, Serial numbers: 100095, 100182, 100194, 100221, 100236, 100239, 100242, 100243, 100247, 100254, 100258, 100259, 100263, 100270, 100285, 100287, 100292, 100298, 100301, 100302, 100307, 100310, 100315, 100323, 100331, 100333, 100339, 100342, 100343, 100348, 100349, 100350, 100357, 100358, 100359, 100360, 100362, 100366, 100367, 100371, 100372, 100375, 100378, 100386, 100390, 100392, 100394, 100396, 100397, 100401, 100402, 100403, 100406, 100409, 100412, 100413, 100418, 100419, 100420, 100423, 100429, 100430, 100432, 100435, 100438, 100448, 100452, 100453, 100455, 100456, 100458, 100462, 100466, 100467, 100472, 100473, 100475, 100476, 100480, 100481, 100482, 100485, 100486, 100489, 100492, 100493, 100495, 100496, 100497, 100498, 100499, 100500, 100502, 100505, 100510, 100514, 100518, 100526, 100529, 100532, 100533, 100536, 100537, 100539, 100540, 100541, 100544, 100546, 100548, 100549, 100552, 100560, 100566, 100570, 100572, 100573, 100575, 100576, 100578, 100582, 100583, 100585, 100591, 100593, 100598, 100603, 100605, 100612, 100614, 100618, 100625, 100626, 100632, 100635, 100636, 100640, 100642, 100643, 100645, 100646, 100647, 100648, 100650, 100653, 100657, 100658, 100661, 100666, 100671, 100672, 100674, 100676, 100679, 100683, 100684, 100687, 100690, 100692, 100693, 100697, 100699, 100700, 100703, 100707, 100711, 100713, 100721, 100722, 100723, 100725, 100726, 100730, 100731, 100735, 100740, 100743, 100746, 100751, 100754, 100755, 100756, 100757, 100758,
Distribution
Worldwide
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-0101-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.