Recall archive / FDA device enforcement
Model Number S701 ALTRUA 2 SR SL Pacemaker — FDA record Z-0098-2026
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Aug 20, 2025. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- Product
- Model Number S701 ALTRUA 2 SR SL Pacemaker
- Reason
- 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).
- Classification
- Class I
- Recalling firm
- Boston Scientific Corporation
- Quantity
- 4841 units
- Agency-reported status
- Ongoing
- Source record identifier
- Z-0098-2026
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | GTIN 00802526576492, Serial numbers: 705372. GTIN 00802526559334. 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GTIN 00802526576492, Serial numbers: 100181, 100206, 100208, 100211, 100216, 100219, 100221, 100231, 100236, 100237, 100238, 100242, 100244, 100245, 100247, 100250, 100251, 100252, 100254, 100257, 100260, 100262, 100265, 100269, 100295, 100302, 100303, 100305, 100306, 100307, 100312, 100314, 100317, 100324, 100325, 100327, 100335, 100336, 100337, 100340, 100343, 100344, 100348, 100354, 100358, 100359, 100360, 100361, 100362, 100364, 100366, 100378, 100382, 100383, 100384, 100386, 100390, 100392, 100393, 100394, 100395, 100396, 100397, 100399, 100400, 100401, 100403, 100404, 100406, 700002, 700003, 700004, 700005, 700006, 700008, 700010, 700011, 700012, 700013, 700014, 700015, 700016, 700017, 700018, 700019, 700020, 700021, 700022, 700023, 700024, 700025, 700027, 700028, 700030, 700031, 700032, 700033, 700034, 700035, 700036, 700037, 700039, 700040, 700041, 700042, 700043, 700044, 700045, 700046, 700047, 700048, 700049, 700050, 700051, 700052, 700053, 700062, 700065, 700068, 700072, 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701903, 701904, 701905, 701908, 701909, 701910, 701911, 701913, 701914, 701915, 701917, 701918, 701919, 701920, 701921... |
The agency lot list is longer than this excerpt. Read the complete list at the official source.
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
Worldwide
No US distribution state could be established from this record. Check the official notice.
Dates in the source
- Report date
- Oct 22, 2025
- Recall initiation date
- Aug 20, 2025
- Center classification date
- Oct 10, 2025
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.