Class 1 Device Recall VALITUDE CRTPs

• Date Initiated by Firm: August 20, 2025
• Date Posted: October 10, 2025
• Recall Status: Open, Classified
• Recall Number: Z-0101-2026
• Recall Event ID: 97467
• PMA Number: P030005
• Product Classification: Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P) - Product Code NKE
• Product: Model Number U125, VALITUDE CRT-P EL
• Code Information: 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, 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GTIN 00802526559389, Serial numbers: 721134. 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GTIN 00802526577109, Serial numbers: 100417, 100426, 100450, 100621, 700009, 700020, 700053, 700090, 700107, 700136, 700147, 700162, 700167, 700176, 700192, 700204, 700223, 700224, 700229, 700230, 700238, 700259, 700402, 700700, 700771, 700786, 700806, 700838, 701388, 701394, 701442, 701933, 701943, 702266, 702270, 702681, 702879, 702993, 703008, 703165, 703171, 703184, 703355, 703492, 703506, 703683, 703806, 703813, 703853, 703893, 704043, 704048, 704302, 704439, 704510, 704512, 704934, 704955, 705054, 705122, 705128, 705173, 705174, 705187, 705241, 705313, 705334, 705345, 705399, 705415, 705538, 705629, 705867, 706010, 706026, 706121, 706125, 706262, 706263, 706323, 706333, 706353, 706420, 706475, 706514, 706539, 706565, 706596, 706609, 706616, 706702, 706706, 706717, 706722, 706724, 706725, 706726, 706738, 707171, 707253, 707254, 707272, 707275, 707284, 707317, 707447, 707508, 707518, 707536, 707636, 707677, 707682, 707686, 707688, 707701, 707742, 707761, 707771, 707775, 707801, 707862, 707891, 707931, 707950, 707960, 707967, 708040, 708145, 708444, 708447, 708568, 708646, 708649, 708653, 708688, 708707, 708729, 708748, 708760, 708800, 709112, 709155, 709156, 709162, 709185, 709189, 709240, 709259, 709267, 709271, 709273, 709305, 709321, 709326, 709382, 709392, 709412, 709464, 709779, 709799, 709839, 709845, 709858, 709864, 709871, 709874, 709896, 709904, 709906, 709913, 709931, 709937, 710029, 710059, 710186, 710307, 710313, 710316, 710320, 710328, 710330, 710332, 710351, 710352, 710363, 710372, 710373, 710376, 710377, 710403, 710536, 710570, 710881, 710916, 710943, 710948, 710995, 710999, 711009, 711127, 711188, 711236, 711247, 711287, 711293, 711301, 711313, 711317, 711323, 711324, 711325, 711328, 711331, 711335, 711357, 711360, 711361, 711394, 711451, 711592, 711794, 711866, 711872, 711960, 712001, 712124, 712343, 712448, 712514, 712527, 712548, 712551, 712560, 712596, 712673, 712690, 712695, 712707, 712708, 712714, 712717, 712746, 712760, 712847, 712865, 712884, 712917, 712928, 712951, 712974, 712982, 712998, 713044, 713048, 713056, 713057, 713107, 713190, 713197, 713204, 713213, 713248, 713285, 713608, 713694, 713712, 713714, 713726, 713734, 713745, 713758, 713777, 713778, 713797, 713811, 713821, 713909, 713910, 714164, 714302, 714304, 714317, 714321, 714338, 714345, 714346, 714347, 714349, 714383, 714385, 714521, 714523, 714543, 714595, 714620, 714705, 714819, 714957, 714993, 714995, 714997, 715049, 715227, 715242, 715265, 715268, 715272, 715280, 715281, 715288, 715289, 715291, 715295, 715334, 715374, 715385, 715393, 715490, 715552, 715564, 715568, 715716, 715844, 716913, 716930, 716938, 717168, 717186, 717231, 717233, 717236, 717242, 717269, 717273, 717275, 717283, 717288, 717289, 717300, 717302, 717304, 717306, 717308, 717309, 717310, 717313, 717316, 717334, 717340, 717347, 717374, 717378, 717481, 717491, 717600, 717604, 717608, 717629, 718017, 718036, 718038, 718047, 718050, 718055, 718060, 718065, 718067, 718068, 718277, 718293, 718321, 718329, 718332, 718333, 718350, 718356, 718384, 718387, 719507, 719565, 719657, 719696, 719702, 719731, 719749, 719861, 719866, 719994, 719995, 720158, 720273, 720520, 720548, 720621, 720624, 720626, 720628, 720629, 720631, 720632, 720641, 720642, 720646, 720647, 720720, 720885, 720902, 720909, 720911, 720918, 720919, 720922, 721144, 721190, 721280, 721292, 721308, 721322, 721324, 721327, 721328, 721337, 721474, 721604, 721622, 721624, 721629, 721645, 721646, 721649, 721851, 721874, 721911, 721913, 721917, 721920, 721950, 721957, 721969, 722106, 722294, 722301, 722315, 722316, 722317, 722323, 722327, 722333, 722429, 722432, 722438, 722455, 722457, 722493, 722640, 722646, 722672, 722681, 722682, 722683, 722692, 722698, 722723, 722732, 722733, 722734, 722735, 722737, 722740, 723192, 723376, 723395, 723401, 723404, 723413, 723442, 723459, 723480, 723863, 723890, 723975, 724058, 724187, 724244, 724410, 724491, 724554, 724561, 724629, 724671, 724726, 724756, 724759, 724761, 724763, 724764, 724767, 724785, 724799, 724801, 724806, 724810, 725016, 725096, 725128, 725181, 725251, 725262, 725322, 725351, 725354, 725408, 725409, 725426, 725441, 725450, 725472, 725488, 725522, 725625, 725628, 725641, 726032, 726160, 726196, 726200, 726240, 726249, 726253, 726265, 726307, 726380, 726408, 726418. GTIN 00802526578793, Serial Numbers: 700074, 700172, 700179, 700190, 700193, 700208, 700253, 700300, 701639, 701995, 701997, 702049, 702178, 702191, 702201, 702208, 702225, 702276, 702277, 702280, 702281, 702299, 702300, 702305, 702308, 702310, 702311, 702333, 702335, 702336, 702338, 702339, 702345, 702362, 702363, 702385, 702394, 702420, 702422, 702426, 702440, 702447, 702451, 702460, 702479, 702480, 702487, 702491, 702493, 702496, 702499, 702500, 702503, 702504, 702532, 702533, 702535, 702538, 702563, 702583, 702589, 702625, 702647, 702675, 702677, 702739, 702750, 702766, 702801, 702802, 702954, 702999, 703022, 703030, 703231, 703239, 703384, 703468, 703533, 703680, 703706, 703718, 703798, 703800, 703801, 703802, 703803, 703824, 703832, 703834, 703837, 703839, 703843, 703856, 703859, 704104, 704746, 704772, 704785, 704806, 704821, 704909, 704990, 705268, 705443, 705494, 705540, 705552, 705559, 705563, 705564, 705571, 705573, 705645, 705650, 705653, 705655, 705696, 705699, 705721, 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• Recalling Firm/ Manufacturer: Boston Scientific Corporation; 4100 Hamline Ave N; Saint Paul MN 55112-5700
• For Additional Information Contact: United States Technical Services; 800-227-3422
• Manufacturer 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).
• FDA Determined Cause: Other
• Action: 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.
• Quantity in Commerce: 3620 units
• Distribution: Worldwide
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• PMA Database: PMAs with Product Code = NKE