Boston Scientific Corporation recalls Model Number U128
Reason for recall
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).
Affected product
Check your device
Enter a lot, serial, REF, or UDI number from your device's label to check it against this recall's listed codes.
Model Number U128, VALITUDE CRT-P EL MRI
Lot / code information
- GTIN
- 00802526559402
- Serial #
100187, 100217, 100222, 100236, 100251, 100253 — +4065 moreShow all
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…
Additional code information
4216, 714222, 714225, 714226, 714228, 714234, 714239, 714242, 714249, 714258, 714270, 714271, 714273, 714276, 714278, 714285, 714287, 714291, 714293, 714298, 714299, 714300, 714306, 714308, 714311, 714312, 714314, 714316, 714319, 714321, 714325, 714326, 714327, 714330, 714335, 714339, 714342, 714343, 714350, 714361, 714362, 714363, 714365, 714366, 714367, 714368, 714370, 714374, 714376, 714378, 714382, 714384, 714385, 714386, 714390, 714391, 714393, 714394, 714395, 714396, 714397, 714398, 714399, 714401, 714402, 714403, 714408, 714409, 714410, 714424, 714425, 714432, 714435, 714436, 714437, 714440, 714442, 714452, 714455, 714456, 714457, 714458, 714462, 714466, 714469, 714473, 714475, 714477, 714478, 714481, 714484, 714486, 714488, 714490, 714491, 714494, 714495, 714497, 714502, 714505, 714506, 714508, 714511, 714512, 714517, 714519, 714520, 714521, 714523, 714527, 714528, 714529, 714531, 714533, 714534, 714535, 714537, 714538, 714540, 714542, 714543, 714545, 714546, 714549, 714550, 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71 …
What the firm is doing
Boston Scientific issued an "Urgent Medical Device Correction" notice to its customers on 08/18/2025 via letter. The notice provides an update to the December 2024 customer communication regarding the potential for the ACCOLADE family of pacemakers to initiate Safety Mode due to a high battery impedance state and contains recommendations timely upgrade of pacemaker software to prevent the occurrence of Safety Mode in an ambulatory setting. On 09/05/2025 an update to the 08/18/2025 notice (via letter), superseding the prior notice to address two unintended behaviors associated with the Model 3869 v2.04 software (designed to prevent potential initiation of Safety Mode due to a high battery impedance condition). The behaviors are: 1. Incomplete disablement of wandless automatic telemetry after detecting a high battery impedance condition. If an ACCOLADE family device with an elevated battery impedance induced Code-1003 remains in service, the software s new telemetry activated battery test is designed to continue assessing battery impedance and disable all wandless telemetry operation before high impedance is achieved and device resets can initiate Safety Mode. 2. Potential for the software s new daily battery test to misinterpret measurements in the presence of a magnet, initiating a false positive response that results in disablement of wandless telemetry sessions. For patients monitored via LATITUDE, this will trigger an alert message indicating an erroneous explant indicator (e.g., explant indicator was reached January 1, 2000) if the device had not previously reached replacement indication, stating that LATITUDE is no longer available, and prompting to contact Technical Services. Patients were notified regarding battery performance. Advisory is published at www.BostonScientific.com/advisory. If you have any questions, contact US Technical Services at 1.800.CARDIAC (227.3422) or email to: tech.services@bsci.com.
DistributionShow detailsHide
Worldwide
A reasonable probability that use of the product will cause serious adverse health consequences or death.
Sources & references
- FDA enforcement recordOfficial FDA database entry for Z-0102-2026
- FDA device classification · NKEOfficial FDA classification for this device type
- FDA recall announcementSearch FDA.gov for the official press announcement
- Find Boston Scientific CorporationSearch for the manufacturer's official notice
- News coverageRecent reporting on this recall and manufacturer
- openFDA data recordThe raw JSON record this page is built from
Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.
Taylor Coteus is RecallWatch's Legal News Analyst, covering FDA medical-device enforcement and patient-safety litigation. He reviews every recall against the FDA's official openFDA record before it is published and is responsible for corrections and editorial accuracy.
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