FDA Medical devices recall · October 22, 2025

Model Number U226, VISIONIST CRT-P EL recall

This is an FDA Class I recall — the most serious type.

Read the official FDA notice ↗

Product

Model Number U226, VISIONIST 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 00802526559457, Serial numbers: 700333, 700335, 700342, 700344, 700346, 700347, 700352, 700364, 700372, 700386, 700388, 700390, 700391, 700425, 700426, 700427, 700428, 700429, 700437, 700448, 700455, 700460, 700461, 700464, 700490, 700498, 700500, 700520, 700538, 700539, 700570, 700587, 700591, 700638, 700653, 700665, 700676, 700693, 700700, 700702, 700704, 700705, 700707, 700708, 700711, 700718, 700720, 700722, 700735, 700736, 700755, 700759, 700765, 700768, 700774, 700782, 700790, 700794, 700796, 700809, 700817, 700830, 700870, 700874, 700879, 700881, 700882, 700883, 700887, 700889, 700903, 700905, 700908, 700911, 700917, 700925, 700935, 700940, 700950, 700951, 700959, 700968, 700970, 700978, 700980, 700984, 700988, 700990, 700991, 700994, 700997, 701005, 701008, 701017, 701019, 701023, 701032, 701038, 701048, 701071, 701083, 701091, 701096, 701097, 701100, 701108, 701116, 701117, 701122, 701127, 701136, 701140, 701141, 701142, 701146, 701147, 701148, 701151, 701153, 701154, 701161, 701165, 701166, 701167, 701174, 701178, 701181, 701182, 701183, 701187, 701192, 701197, 701199, 701201, 701203, 701207, 701212, 701217, 701240, 701242, 701247, 701249, 701252, 701255, 701256, 701318, 701320, 701321, 701330, 701334, 701335, 701342, 701349, 701356, 701425, 701427, 701439, 701440, 701446, 701447, 701448, 701462, 701490, 701510, 701511, 701517, 701525, 701528, 701529, 701532, 701537, 701538, 701539, 701543, 701547, 701550, 701551, 701556, 701559, 701562, 701563, 701564, 701589,

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-0104-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.