Class I U.S. Food and Drug Administration

Boston Scientific Corporation recall: Software to enhance Safety Architecture is available and designed to prevent

Recall published 1+ years ago

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).

The hazard: Device safety concern

This is a device enforcement record. Check whether the remedy is a correction, a software update or a removal before changing anything.

What the notice says: 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).

Why it matters: The FDA recorded an enforcement action against this device. Most device recalls are corrections rather than removals, so the device often stays in use while the manufacturer issues a fix.

Recall details

Recall number
Z-0090-2026
Published
October 22, 2025
Risk level
Class I
Status
Ongoing
Issued by
U.S. Food and Drug Administration
Brand
Boston Scientific Corporation
Product type
Medical devices
Units affected
3592 units
Made in
United States
Lot / code info
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. GTIN 00802526578045, Serial Numbers: 100200, 100307, 100313, 100316, 100327, 100329, 702672, 702711, 702810, 702921, 703010, 703011, 703012, 703080, 703124, 703130, 703143, 703149, 703156, 703177, 703180, 703184, 703185, 703189, 703195, 703204, 703228, 703230, 703234, 703235, 703243, 703244, 703252, 703256, 703257, 703265, 703267, 703268, 703270, 703272, 703273, 703279, 703283, 703284, 703288, 703296, 703297, 703298, 703299, 703300, 703303, 703307, 703311, 703312, 703313, 703315, 703322, 703323, 703329, 703439, 703485, 703487, 703488, 704720, 704832, 704879, 704883, 704911, 704935, 704939, 704943, 704957, 704963, 704993, 705071, 705073, 705074, 705207, 705209, 705240, 705639, 706096, 706447, 706517, 706548, 706554, 706562, 706568, 706577, 706579, 706616, 706647, 706682, 706684, 706734, 706765, 706766, 706824, 706846, 706858, 706891, 706912, 706913, 706920, 706923, 706926, 706936, 706946, 706956, 706991, 707016, 707043, 707101, 707111, 707115, 707116, 707117, 707138, 707144, 707149, 707160, 707171, 707172, 707188, 707205, 707216, 707220, 707232, 707264, 707284, 707301, 707342, 707358, 707359, 707453, 707491, 707523, 707528, 707540, 707547, 707551, 707552, 707600, 707750, 707782, 707879, 707895, 707917, 707930, 707953, 707990, 708100, 708117, 708126, 708159, 708225, 708332, 708413, 708414, 708427, 708434, 708444, 708479, 708480, 708488, 708490, 708497, 708500, 708505, 708506, 708507, 708511, 708513, 708514, 708516, 708520, 708525, 708528, 708531, 708548, 708551, 708559, 708562, 708563, 708567, 708573, 708575, 708578, 708581, 708583, 708584, 708585, 708590, 708597, 708600, 708601, 708606, 708607, 708610, 708612, 708614, 708617, 708624, 708625, 708634, 708639, 708640, 708643, 708644, 708645, 708647, 708648, 708654, 708657, 708659, 708665, 708692, 708700, 708703, 708714, 708751, 708753, 708756, 708757, 708760, 708761, 708762, 708763, 708837, 708846, 708849, 708851, 708860, 708889, 708890, 708918, 708920, 708925, 708927, 708945, 708955, 708981, 708990, 709028, 709029, 709032, 709036, 709040, 709041, 709046, 709049, 709051, 709054, 709057, 709…
UPC codes
00802526578045, 00802526559129, 00802526576416

Products covered by this recall

Model Number L221 PROPONENT DR EL Pacemaker

Check your product

The notice names 11 codes you can read straight off the package. Type the one printed on yours and the list below narrows to it.

UPC / barcode

Read the twelve digits under the barcode on the package.

  • 00802526578045
  • 00802526559129
  • 00802526576416

Serial number

On the rating plate, often next to the date of manufacture.

  • 723080
  • 723248
  • 725570
  • 100200
  • 100307
  • 100313
  • 100316
  • 100327

Codes are lifted verbatim from the FDA — Device enforcement notice. A code that is missing here may still be covered — the official notice is the complete list.

What to do about Device

Boston Scientific Corporation — This is a device enforcement record. Check whether the remedy is a correction, a software update or a removal before changing anything.

  1. Match the model, catalogue, lot and serial numbers on your device against the identifiers on this page.
  2. Ask the supplier or clinic that provided it what the remedy is in your case.
  3. If you are a facility, quarantine affected stock and log the correction.
  4. Report device problems to the FDA through MedWatch.

Replacements, repairs and reimbursement

Device remedies run through the supply chain, so the route depends on who sold you the unit.

  • Contact the distributor or clinic named on your paperwork and quote the recall number on this page. They will tell you whether the remedy is a repair, a replacement or an instruction update.
  • If the device was billed to insurance or Medicare, the replacement is usually billed the same way; you should not face a second deductible for a recall.
  • Keep every piece of correspondence. If a recalled device caused harm, that paper trail is what a claim rests on.
  • Consumer-purchased devices such as monitors and test kits are normally replaced free, with return shipping paid.

Company contact: Boston Scientific Corporation — 4100 Hamline Ave N, Saint Paul, MN, 55112-5700

The official notice

This page summarises a notice published by U.S. Food and Drug Administration. The agency notice is the authoritative version — read it before you act, and treat it as the final word if anything here looks different.

Open the FDA — Device enforcement record U.S. Food and Drug Administration recalls

Questions people ask about this recall

Why was Boston Scientific Corporation medical devices 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). 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…

How do I know if I have the recalled product?

Match the codes printed on your package against the notice: UPC 00802526578045, 00802526559129, 00802526576416. If the code on your package is not on that list, your unit is outside the recall.

What should I do with it right now?

Match the model, catalogue, lot and serial numbers on your device against the identifiers on this page.

Can I get my money back?

Contact the distributor or clinic named on your paperwork and quote the recall number on this page. They will tell you whether the remedy is a repair, a replacement or an instruction update.

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