CLASS I ONGOING Device recall · Reported 22 Oct 2025 · FDA Enforcement Report

Proponent SR Sl recalled by Boston Scientific

Boston Scientific is recalling Proponent SR Sl (. The recall was initiated on 20 Aug 2025 and the FDA has classified it as Class I.

Check your package

Lot, batch or date codesGTIN 00802526559020, Serial numbers: 722605, 722614, 722634, 722647. GTIN 00802526576362, Serial numbers: 464359, 464382, 464387, 464444, 464447, 464457, 464462, 464471, 464505, 464511, 464514, 464517, 464521, 464525, 464527, 464541, 464549, 464552, 464554, 464561, 464576, 708351, 708451, 708466, 708471, 708495, 708513, 708514, 708515, 708516, 708517, 708525, 708529, 708532, 708533, 708536, 708618, 708619, 708620, 708622, 708623, 708624, 708625, 708627, 708630, 708651, 708653, 708654, 708655, 708656, 708658, 708660, 708737, 708751, 708764, 708783, 708816, 708824, 708826, 708857, 708862, 708867, 708868, 708879, 708880, 708885, 708887, 708889, 708894, 708898, 708912, 708920, 708922, 708924, 708929, 708939, 708942, 708944, 708945, 708946, 708947, 708948, 708949, 708952, 708959, 708960, 708967, 708968, 708969, 708976, 708980, 708983, 708997, 709003, 709009, 709011, 709015, 709024, 709025, 709037, 709040, 709041, 710248, 710517, 710627, 710705, 710754, 710765, 710771, 710772, 710788, 710789, 710790, 710824, 710825, 710831, 710889, 710905, 710907, 710910, 710916, 710931, 710954, 710980, 711315, 711412, 711640, 711655, 714062, 714644, 714688, 714708, 715328, 717903, 717931, 717934, 717941, 717948, 717950, 717951, 717965, 717976, 717981, 717982, 717992, 718007, 718009, 718138, 718522, 718780, 718783, 718937, 720309, 720504, 720556, 720597, 720650, 721983, 721991, 722012, 722438, 722565, 722689, 722724, 722756, 722967, 723456, 724170, 724319, 724398, 724404, 724485, 724623, 725175, 725182, 725198, 725262, 725272, 725283, 725363, 725365, 725368, 725370, 725371, 725372, 725373, 725383, 725388, 725389, 725390, 725392, 725404, 725409, 725418, 725419, 725425, 725444, 727098, 728855, 728893, 728894, 728917, 728922, 729054, 729410, 729411, 729413, 729421, 729589, 729599, 729602, 731110, 731612, 734834. GTIN 00802526578007, Serial Numbers: 464370, 464388, 464446, 464452, 464458, 464460, 464467, 464468, 464470, 464475, 464477, 464481, 464482, 464483, 464486, 464490, 464491, 464492, 464498, 464500, 464501, 464506, 464508, 464512, 464516, 464519, 464523, 464526, 464528, 464532, 464563, 464568, 464570, 464590, 705011, 705236, 705383, 705409, 705419, 705462, 705468, 705555, 705576, 705584, 705622, 705628, 705702, 705706, 705711, 705713, 705728, 705751, 705753, 705795, 705812, 706007, 706098, 706215, 706321, 706350, 706372, 706698, 706846, 706879, 706918, 706923, 706931, 706947, 706967, 707053, 707069, 707089, 707138, 707173, 708261, 708473, 708494, 708504, 708528, 708534, 708546, 708549, 708585, 708589, 708595, 708629, 708652, 708657, 708721, 708722, 708723, 708749, 708750, 708752, 708770, 708774, 708775, 708776, 708780, 708797, 708798, 708802, 708815, 708819, 708820, 708831, 708832, 708841, 708843, 708844, 708848, 708851, 708853, 708858, 708859, 708874, 708877, 708883, 708886, 708892, 708896, 708905, 708907, 708910, 708913, 708914, 708915, 708916, 708917, 708918, 708923, 708925, 708928, 708930, 708932, 708933, 708935, 708936, 708937, 708938, 708940, 708941, 708943, 708950, 708956, 708958, 708965, 708966, 708971, 708974, 708975, 708977, 708978, 708981, 708982, 708984, 708986, 708987, 708992, 709000, 709002, 709004, 709006, 709007, 709008, 709012, 709013, 709014, 709016, 709023, 709027, 709029, 709033, 709034, 709039, 709042, 709043, 709044, 709045, 710352, 710458, 710499, 710501, 710532, 710562, 710568, 710569, 710577, 710667, 710675, 710676, 710727, 710729, 710735, 710739, 710766, 710769, 710796, 710801, 710802, 710808, 710811, 710820, 710895, 710897, 710903, 710921, 710957, 710982, 711020, 711082, 711102, 711225, 711231, 711235, 711286, 711314, 711328, 711345, 711353, 711354, 711356, 711455, 711473, 711530, 711534, 711546, 711552, 711562, 711569, 711577, 711594, 711596, 711598, 711599, 711604, 711611, 711614, 711616, 711617, 711619, 711641, 711763, 711765, 711768, 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733536, 733537, 733539, 733540, 733926, 733954, 733961, 734000, 734423, 734499, 734508, 734514, 734535, 734563, 734575, 734676, 734682, 734729, 734842, 734886, 734979, 734986, 734989, 734997, 735022, 735024, 735032, 735037, 735038, 735047, 735051, 735055, 735061, 735062, 735063, 735066, 735070, 735075, 735078, 735084, 735094, 735604.

Quantity recalled1380 units

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-0085-2026
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: Other Medical Devices

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

PROPONENT SR SL (Model L200)

Where it was distributed

Worldwide

Questions about this recall

Why was it recalled?

Which lots are affected?

GTIN 00802526559020, Serial numbers: 722605, 722614, 722634, 722647. GTIN 00802526576362, Serial numbers: 464359, 464382, 464387, 464444, 464447, 464457, 464462, 464471, 464505, 464511, 464514, 464517, 464521, 464525, 464527, 464541, 464549, 464552, 464554, 464561, 464576, 708351, 708451, 708466, 708471, 708495, 708513, 708514, 708515, 708516, 708517, 708525, 708529, 708532, 708533, 708536, 708618, 708619, 708620, 708622, 708623, 708624, 708625, 708627, 708630, 708651, 708653, 708654, 708655, 708656, 708658, 708660, 708737, 708751, 708764, 708783, 708816, 708824, 708826, 708857, 708862, 708867, 708868, 708879, 708880, 708885, 708887, 708889, 708894, 708898, 708912, 708920, 708922, 708924, 708929, 708939, 708942, 708944, 708945, 708946, 708947, 708948, 708949, 708952, 708959, 708960, 708967, 708968, 708969, 708976, 708980, 708983, 708997, 709003, 709009, 709011, 709015, 709024, 709025, 709037, 709040, 709041, 710248, 710517, 710627, 710705, 710754, 710765, 710771, 710772, 710788, 710789, 710790, 710824, 710825, 710831, 710889, 710905, 710907, 710910, 710916, 710931, 710954, 710980, 711315, 711412, 711640, 711655, 714062, 714644, 714688, 714708, 715328, 717903, 717931, 717934, 717941, 717948, 717950, 717951, 717965, 717976, 717981, 717982, 717992, 718007, 718009, 718138, 718522, 718780, 718783, 718937, 720309, 720504, 720556, 720597, 720650, 721983, 721991, 722012, 722438, 722565, 722689, 722724, 722756, 722967, 723456, 724170, 724319, 724398, 724404, 724485, 724623, 725175, 725182, 725198, 725262, 725272, 725283, 725363, 725365, 725368, 725370, 725371, 725372, 725373, 725383, 725388, 725389, 725390, 725392, 725404, 725409, 725418, 725419, 725425, 725444, 727098, 728855, 728893, 728894, 728917, 728922, 729054, 729410, 729411, 729413, 729421, 729589, 729599, 729602, 731110, 731612, 734834. GTIN 00802526578007, Serial Numbers: 464370, 464388, 464446, 464452, 464458, 464460, 464467, 464468, 464470, 464475, 464477, 464481, 464482, 464483, 464486, 464490, 464491, 464492, 464498, 464500, 464501, 464506, 464508, 464512, 464516, 464519, 464523, 464526, 464528, 464532, 464563, 464568, 464570, 464590, 705011, 705236, 705383, 705409, 705419, 705462, 705468, 705555, 705576, 705584, 705622, 705628, 705702, 705706, 705711, 705713, 705728, 705751, 705753, 705795, 705812, 706007, 706098, 706215, 706321, 706350, 706372, 706698, 706846, 706879, 706918, 706923, 706931, 706947, 706967, 707053, 707069, 707089, 707138, 707173, 708261, 708473, 708494, 708504, 708528, 708534, 708546, 708549, 708585, 708589, 708595, 708629, 708652, 708657, 708721, 708722, 708723, 708749, 708750, 708752, 708770, 708774, 708775, 708776, 708780, 708797, 708798, 708802, 708815, 708819, 708820, 708831, 708832, 708841, 708843, 708844, 708848, 708851, 708853, 708858, 708859, 708874, 708877, 708883, 708886, 708892, 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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 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

9 other products · FDA event 97467

This product is part of a recall event; the main page for the event is Model Number S702, Altrua 2 DR SL Pacemaker recalled.

Reported	Class	Recall	Company	Reason	Where
22 Oct 2025	CLASS I	Model Number S702, Altrua 2 DR SL Pacemaker recalled	Boston Scientific	Device Malfunction	MN
22 Oct 2025	CLASS I	Model Number L209 Proponent DR (VDD) SL Pacemaker recalled	Boston Scientific	Device Malfunction	MN
22 Oct 2025	CLASS I	Model Number U226, Visionist Crt-p EL recalled by Boston Scientific	Boston Scientific	Device Malfunction	MN
22 Oct 2025	CLASS I	Model Number L221 Proponent DR EL Pacemaker recalled	Boston Scientific	Device Malfunction	MN
22 Oct 2025	CLASS I	Accolade Dr El recalled by Boston Scientific	Boston Scientific	Device Malfunction	MN
22 Oct 2025	CLASS I	Model Number S701 Altrua 2 SR SL Pacemaker recalled by Boston Scientific	Boston Scientific	Device Malfunction	MN
22 Oct 2025	CLASS I	Model Number L100, Essentio SR SL Pacemaker recalled	Boston Scientific	Device Malfunction	MN
22 Oct 2025	CLASS I	Proponent Dr Sl recalled by Boston Scientific	Boston Scientific	Device Malfunction	MN
22 Oct 2025	CLASS I	Model Number S722, Altrua 2 DR EL Pacemaker recalled	Boston Scientific	Device Malfunction	MN

More recalls from Boston Scientific

All 628

Reported	Class	Recall	Company	Reason	Where
30 Sep 2026Device	CLASS I	Imager II Angiographic Catheters M001314001 Imager recalled	Boston Scientific	Other	Nationwide
23 Sep 2026Device	CLASS II	StoneSmart Connect Console Contents: Power Cord recalled	Boston Scientific	Other	Nationwide
9 Sep 2026Device	CLASS II	Lux-Dx, Lux-Dx II, Lux-Dx II+ Insertable Cardiac Monitor recalled	Boston Scientific	Device Malfunction	Nationwide
9 Sep 2026Device	CLASS II	Lux-Dx, Lux-Dx II, Lux-Dx II+ Insertable Cardiac Monitor recalled	Boston Scientific	Device Malfunction	Nationwide
9 Sep 2026Device	CLASS II	Lux-Dx, Lux-Dx II, Lux-Dx II+ Insertable Cardiac Monitor recalled	Boston Scientific	Device Malfunction	Nationwide

Other Other Medical Devices recalls

All 13,857

Reported	Class	Recall	Company	Reason	Where
30 Sep 2026Device	CLASS II	Medline Convenience Kits: Major Pack recalled by Medline Industries	Medline Industries	Other	Nationwide
30 Sep 2026Device	CLASS II	Medline Convenience Kits: Peds Sinus Pack recalled by Medline Industries	Medline Industries	Other	Nationwide
30 Sep 2026Device	CLASS II	SmartPath to dStream for XR and 3.0T recalled by Philips North America	Philips North America	Device Malfunction	Nationwide
30 Sep 2026Device	CLASS II	Achieva 1.5T, Achieva 1.5T Conversion recalled by Philips North America	Philips North America	Device Malfunction	Nationwide
30 Sep 2026Device	CLASS II	Medline Convenience Kits: Mfc Craniotomy Pack recalled	Medline Industries	Other	Nationwide