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

A device recall was filed for this product. For anything implanted or relied on daily, the clinician comes before the paperwork.

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-0098-2026
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
4841 units
Made in
United States
Lot / code info
GTIN 00802526576492, Serial numbers: 705372. GTIN 00802526559334. Serial numbers: 100002, 100003, 100004, 100005, 100007, 100008, 100009, 100010, 100011, 100012, 100013, 100014, 100015, 100016, 100017, 100018, 100019, 100020, 100021, 100022, 100023, 100025, 100026, 100027, 100028, 100030, 100031, 100032, 100033, 100034, 100035, 100036, 100037, 100038, 100039, 100040, 100041, 100042, 100043, 100044, 100045, 100046, 100047, 100048, 100049, 100050, 100051, 100052, 100053, 100054, 100055, 100056, 100057, 100058, 100059, 100060, 100061, 100062, 100063, 100064, 100065, 100066, 100067, 100068, 100069, 100070, 100071, 100072, 100073, 100075, 100076, 100077, 100078, 100079, 100081, 100082, 100083, 100084, 100085, 100086, 100087, 100088, 100090, 100091, 100092, 100093, 100094, 100095, 100096, 100097, 100098, 100099, 100100, 100101, 100102, 100103, 100104, 100106, 100109, 100111, 100112, 100114, 100115, 100116, 100117, 100118, 100120, 100121, 100123, 100124, 100126, 100127, 100128, 100129, 100130, 100131, 100132, 100133, 100135, 100136, 100137, 100138, 100139, 100140, 100141, 100142, 100143, 100144, 100145, 100146, 100147, 100148, 100149, 100150, 100151, 100152, 100153, 100154, 100155, 100156, 100158, 100160, 100161, 100162, 100163, 100164, 100165, 100166, 100167, 100169, 100170, 100171, 100172, 100174, 100175, 100176, 100177, 100178, 100179, 100180, 100182, 100183, 100185, 100186, 100187, 100188, 100189, 100190, 100191, 100192, 100193, 100195, 100196, 100197, 100198, 100200, 100201, 100202, 100203, 100205, 100210, 100212, 100214, 100218, 100220, 100222, 100224, 100225, 100228, 100229, 100230, 100232, 100234, 100235, 100239, 100240, 100241, 100246, 100248, 100249, 100255, 100259, 100263, 100266, 100267, 100268, 100270, 100271, 100272, 100275, 100278, 100279, 100280, 100282, 100283, 100284, 100285, 100286, 100287, 100289, 100290, 100291, 100292, 100294, 100296, 100298, 100300, 100301, 100308, 100310, 100311, 100315, 100316, 100318, 100321, 100322, 100323, 100326, 100328, 100330, 100331, 100332, 100338, 100339, 100342, 100345, 100346, 100347, 100349, 100350, 100351, 100352, 100353, 100355, 100356, 100365, 100367, 100368, 100369, 100370, 100371, 100372, 100373, 100374, 100375, 100376, 100377, 100379, 100380, 100381, 100385, 100387, 100388, 100389, 100402, 100405, 700001, 700054, 700055, 700056, 700057, 700058, 700059, 700060, 700063, 700066, 700067, 700069, 700070, 700071, 700073, 700078, 700079, 700080, 700084, 700085, 700086, 700087, 700093, 700094, 700098, 700099, 700101, 700102, 700108, 700110, 700114, 700116, 700121, 700126, 700128, 700130, 700131, 700132, 700135, 700142, 700143, 700146, 700156, 700157, 700158, 700165, 700166, 700178, 700189, 700191, 700238, 700243, 700245, 700258, 700351, 700360, 700363, 700371, 700392, 700398, 700400, 700596, 700597, 700598, 700599, 700600, 700601, 700602, 700603, 700604, 700607, 700608, 700609, 700611, 700612, 700614, 700615, 700633, 700634, 700635, 700636, 700637, 700638, 700639, 700640, 700641, 700643, 700656, 700657, 700658, 700659, 700660, 700661, 700662, 700663, 700664, 700666, 700667, 700668, 700669, 700711, 700713, 700714, 700715, 700719, 700720, 700722, 700723, 700724, 700739, 700749, 700768, 700771, 700798, 700822, 700824, 700825, 700830, 700833, 700842, 700862, 700865, 700866, 700878, 700898, 700899, 700900, 700902, 700909, 700910, 700913, 700919, 700925, 700940, 700948, 700952, 700957, 700959, 700961, 700962, 700963, 700964, 700965, 700973, 700981, 700989, 701005, 701009, 701011, 701016, 701025, 701027, 701028, 701034, 701035, 701036, 701038, 701042, 701050, 701062, 701068, 701069, 701076, 701090, 701104, 701105, 701111, 701117, 701118, 701131, 701133, 701136, 701142, 701150, 701151, 701152, 701155, 701160, 701166, 701197, 701198, 701199, 701223, 701229, 701293, 701298, 701305, 701306, 701315, 701323, 701334, 701335, 701336, 701337, 701338, 701347, 701348, 701351, 701359, 701373, 701377, 701378, 701380, 701385, 701388, 701395, 701396, 701403, 701409, 701414, 701422, 701424, 701425, 70142…
UPC codes
00802526576492, 00802526559334

Products covered by this recall

Model Number S701 ALTRUA 2 SR SL Pacemaker

Check your product

The notice names 2 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.

  • 00802526576492
  • 00802526559334

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 — A device recall was filed for this product. For anything implanted or relied on daily, the clinician comes before the paperwork.

  1. Match the model, catalogue, lot and serial numbers on your device against the identifiers on this page.
  2. Report device problems to the FDA through MedWatch.
  3. If the device is implanted or you depend on it daily, speak to your clinician before changing how you use it.
  4. Ask the supplier or clinic that provided it what the remedy is in your case.

Claiming on a recalled device

Device recalls are tracked by serial and lot number, so your claim moves faster if you lead with those.

  • Have the model, catalogue, lot and serial numbers ready before you call — they are on the device label or its box.
  • Ask explicitly whether your unit is in the affected range; many recalls cover only part of a model line.
  • If you need the device daily, ask what interim arrangement they offer while the remedy is carried out.
  • Log the date, the name and the reference number of every call. Device recalls can run for months.

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 00802526576492, 00802526559334. 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?

Have the model, catalogue, lot and serial numbers ready before you call — they are on the device label or its box.

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