CLASS I ONGOING Device recall · Reported 22 Oct 2025 · FDA Enforcement Report
Model Number L221 Proponent DR EL Pacemaker recalled
Boston Scientific is recalling Model Number L221 Proponent DR EL Pacemaker. The recall was initiated on 20 Aug 2025 and the FDA has classified it as Class I.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0090-2026
- FDA event ID
- 97467
- Recalling firm
- Boston Scientific, Saint Paul, MN
- Classification
- Class I
- Status
- Ongoing
- Recall initiated
- 20 Aug 2025
- FDA classified
- 10 Oct 2025
- Reported
- 22 Oct 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- Pacemakers & Defibrillators
Timeline
| 20 Aug 2025 | Recall initiated by company | |
| 10 Oct 2025 | Classified by FDA | +51 days |
| 22 Oct 2025 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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).
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
Model Number L221 PROPONENT DR EL Pacemaker
Where it was distributed
Worldwide
Questions about this recall
Is Model Number L221 Proponent DR EL Pacemaker recalled?
Yes. Boston Scientific recalled Model Number L221 Proponent DR EL Pacemaker on 20 Aug 2025. The recall is Class I and its status is Ongoing. Recall number Z-0090-2026.
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).
Which lots are affected?
GTIN 00802526578045, Serial Numbers: 723080, 723248, 725570, 729255. GTIN 00802526559129. Serial Numbers: 732639. GTIN 00802526576416, Serial numbers: 100156, 100157, 100167, 100180, 100185, 100247, 100254, 100263, 100268, 100272, 100278, 100279, 100282, 100293, 100296, 100302, 100304, 100305, 100306, 100308, 100314, 100315, 100332, 100335, 100336, 100453, 702524, 702763, 703141, 703183, 703341, 703490, 704875, 705065, 705069, 706965, 707072, 707119, 707355, 707474, 707499, 707999, 708019, 708170, 708229, 709024, 712293, 712330, 712402, 712408, 712424, 712437, 712517, 713937, 714362, 714643, 714710, 714836, 714847, 715761, 715890, 716146, 716435, 716731, 717103, 717117, 717537, 718007, 718062, 718114, 718137, 718139, 718301, 718312, 719571, 719630, 719635, 719637, 719653, 719835, 720752, 720838, 721277, 721298, 721511, 721604, 722560, 723084, 723234, 723279, 723335, 723486, 723491, 723494, 723498, 723509, 723529, 723557, 723559, 723562, 723573, 723625, 724616, 724666, 724696, 724709, 724782, 724819, 724838, 724846, 724853, 724857, 724890, 724914, 725181, 725182, 725183, 725184, 725185, 725186, 725187, 725188, 725189, 725190, 725586, 725603, 725604, 725605, 725607, 725608, 725609, 725610, 725727, 725792, 725801, 726384, 726419, 726545, 726800, 726801, 726878, 727128, 727172, 727178, 727236, 727242, 727255, 727257, 727262, 727263, 727268, 727271, 727292, 727315, 727323, 727335, 727346, 727376, 727378, 727379, 727382, 728093, 728135, 728139, 728153, 728301, 728324, 728381, 728658, 728682, 728690, 728694, 728713, 728881, 728905, 728908, 728911, 728967, 728981, 728982, 729013, 729066, 729068, 729069, 729071, 729075, 729081, 729083, 729237, 729258, 729321, 729323, 729340, 729390, 729736, 730067, 730087, 730237, 730238, 730239, 731097, 731100, 731104, 731106, 731110, 731118, 731150, 731166, 731168, 731198, 731279, 731294, 731306, 733065, 733285, 733332, 733838, 734232, 734237, 734238, 734261, 735042. 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732708, 732710, 732711, 732712, 732713, 732719, 732720, 732721, 732723, 732724, 732725, 732727, 732728, 732729, 732731, 732732, 732735, 732737, 732738, 732740, 732741, 732742, 732746, 732748, 732749, 732751, 732754, 732756, 732757, 732758, 732759, 732760, 732764, 732765, 732766, 732767, 732768, 732769, 732770, 732771, 732774, 732783, 732784, 732786, 732789, 732790, 732791, 732792, 732793, 732794, 732795, 732806, 732807, 732812, 732814, 732828, 732842, 732855, 732856, 732857, 732858, 732865, 732866, 732869, 732874, 732879, 732880, 732884, 732887, 732889, 732890, 732891, 732894, 732895, 732897, 732898, 732899, 732901, 732902, 732904, 732907, 732912, 732915, 732916, 732918, 732920, 732921, 732948, 732988, 732989, 732990, 732994, 732995, 732998, 733009, 733011, 733013, 733016, 733017, 733018, 733020, 733030, 733034, 733038, 733040, 733042, 733044, 733057, 733068, 733069, 733070, 733077, 733090, 733104, 733114, 733116, 733154, 733174, 733192, 733206, 733221, 733226, 733233, 733241, 733243, 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Where was it sold?
Worldwide
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class I mean?
Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Boston Scientific
All 626| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Lux-Dx, Lux-Dx II, Lux-Dx II+ Insertable Cardiac Monitor recalled | Boston Scientific | Device Malfunction | Nationwide |
| Device | CLASS II | Lux-Dx, Lux-Dx II, Lux-Dx II+ Insertable Cardiac Monitor recalled | Boston Scientific | Device Malfunction | Nationwide |
| Device | CLASS II | Lux-Dx, Lux-Dx II, Lux-Dx II+ Insertable Cardiac Monitor recalled | Boston Scientific | Device Malfunction | Nationwide |
| Device | CLASS I | Enroute Transcarotid Neuroprotection System recalled | Boston Scientific | Other | Nationwide |
| Device | CLASS I | Enroute Transcarotid Neuroprotection System Plus recalled | Boston Scientific | Other | Nationwide |
Other Pacemakers & Defibrillators recalls
All 494| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | DermaV Laser System recalled by Lutronic | Lutronic | Other | Nationwide |
| Device | CLASS II | Convenience kits containing select SKUs of Polycarbonate recalled | Medline Industries | Other | Nationwide |
| Device | CLASS II | Medline convenience kits: Loop Pack DYNJ61460C Open Heart recalled | Medline Industries | Device Malfunction | Nationwide |
| Device | CLASS II | Medline convenience kits: Acl Pack DYNJ64161C Arthroscopy recalled | Medline Industries | Foreign Material | Nationwide |
| Device | CLASS II | Medline convenience kits: Bib AV Fistula Pack DYNJ58304B recalled | Medline Industries | Device Malfunction | Nationwide |