FDA Device recall Z-0098-2026

Model Number S701 ALTRUA 2 SR SL Pacemaker

FDA Device
Class I
ongoing
Published 2025-10-22

On 2025-10-22 the FDA classified a Class I recall of Model Number S701 ALTRUA 2 SR SL Pacemaker by Boston Scientific, citing 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 ACCOL….

Read the official FDA Device notice

Agency	FDA Device
Recall number	Z-0098-2026
Classification	Class I
Status	ongoing
Initiated	2025-08-20
Published	2025-10-22
Last updated	2026-09-13 11:57 UTC
Company	Boston Scientific
Distribution	n/a

Product

Model Number S701 ALTRUA 2 SR SL Pacemaker

Reason

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).

Identifiers

code_info	GTIN 00802526576492, Serial numbers: 705372. GTIN 00802526559334. Serial numbers: 100002, 100003, 100004, 100005, 1… 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, 10

code_info

GTIN 00802526576492, Serial numbers: 705372. GTIN 00802526559334. Serial numbers: 100002, 100003, 100004, 100005, 1…

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, 10

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0098-2026%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.