FDA Medical devices recall ·
Model Number L211 PROPONENT DR SL MRI Pacemaker recall
This is an FDA Class I recall — the most serious type.
- Recall number
- Z-0089-2026
- 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
- 106,536 units
- Hazard tags
- Software
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
Model Number L211 PROPONENT DR SL MRI Pacemaker
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 00802526559105, Serial Numbers: 296409, 658411. GTIN 00802526576409, Serial Numbers: 431535. GTIN 00802526578038, Serial Numbers: 251896, 375153, 396268. GTIN 00802526559105, Serial Numbers: 100009, 100020, 100022, 100024, 100028, 100030, 100031, 100037, 100038, 100039, 100043, 100046, 100047, 100048, 100049, 100052, 100053, 100058, 100061, 100063, 100066, 100068, 100075, 100077, 100078, 100080, 100083, 100087, 100090, 100091, 100095, 100097, 100098, 100106, 100113, 100122, 100125, 100127, 100130, 100131, 100132, 100133, 100143, 100145, 100156, 100158, 100163, 100166, 100167, 100168, 100170, 100172, 100174, 100175, 100179, 100187, 100188, 100191, 100194, 100198, 100206, 100207, 100209, 100210, 100213, 100217, 100218, 100219, 100220, 100221, 100222, 100223, 100224, 100225, 100226, 100230, 100231, 100237, 100244, 100246, 100247, 100248, 100249, 100268, 100269, 100270, 100271, 100275, 100280, 100281, 100290, 100291, 100309, 100316, 100334, 100390, 100395, 100398, 100427, 100430, 100438, 100446, 100460, 100462, 100478, 100482, 100487, 100488, 100493, 100497, 100505, 100509, 100510, 100513, 100514, 100516, 100522, 100527, 100529, 100532, 100537, 100542, 100551, 100555, 100559, 100565, 100567, 100571, 100576, 100578, 100580, 100584, 100585, 100592, 100594, 100598, 100600, 100601, 100606, 100612, 100613, 100617, 100618, 100619, 100621, 100622, 100623, 100631, 100634, 100638, 100643, 100647, 100648, 100649, 100651, 100652, 100653, 100659, 100660, 100668, 100669, 100670, 100672,
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-0089-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.