FDA Device recall Z-2001-2021

Altrua 2 pacemaker, Models: a) S701 b) S702 c) S722

FDA Device
Class II
ongoing
Published 2021-07-14

On 2021-07-14 the FDA classified a Class II recall of Altrua 2 pacemaker, Models: a) S701 b) S702 c) S722 by Boston Scientific, citing latent release of small amounts of hydrogen within the pacemaker may cause a low voltage capacitor to become electrically compromised over time resulting in accelerated battery de….

Read the official FDA Device notice

Agency	FDA Device
Recall number	Z-2001-2021
Classification	Class II
Status	ongoing
Initiated	2021-06-03
Published	2021-07-14
Last updated	2026-09-13 11:56 UTC
Company	Boston Scientific
Distribution	n/a

Product

Altrua 2 pacemaker, Models: a) S701 b) S702 c) S722

Reason

Latent release of small amounts of hydrogen within the pacemaker may cause a low voltage capacitor to become electrically compromised over time resulting in accelerated battery depletion of the battery and associated progression of displayed battery depletion indicators.

Identifiers

code_info	a) S701, Serial Numbers: 100005, 100011, 100012, 100015, 100017, 100021, 100022, 100028, 100032, 100034, 100037, 10005… a) S701, Serial Numbers: 100005, 100011, 100012, 100015, 100017, 100021, 100022, 100028, 100032, 100034, 100037, 100053, 100055, 100059, 100060, 100068, 100075, 100079, 100082, 100083, 100090, 100095, 100098, 100103, 100106, 100116, 100119, 100122, 100124, 100128, 100132, 100135, 100139, 100141, 100148, 100149, 100205, 100208, 100211, 100213, 100221, 100230, 100231, 100232, 100234, 100236, 100238, 100239, 100245, 100247, 100251, 100252, 100254, 100255, 100262, 100265, 100269, 100303, 100305, 100306, 100311, 100348, 100366, 100377, 100378, 100380, 100383, 100390, 100391, 100392, 100393, 100394, 100395, 100396, 100399, 100400, 100401, 100403, 100405, 100406, 700002, 700003, 700004, 700005, 700006, 700008, 700010, 700021, 700022, 700023, 700024, 700025, 700026, 700027, 700028, 700029, 700031, 700036, 700037, 700039, 700040, 700042, 700043, 700044, 700046, 700047, 700048, 700049, 700050, 700051, 700055, 700062, 700067, 700081, 700083, 700084, 700086, 700089, 700091, 700092, 700093, 700095

code_info

a) S701, Serial Numbers: 100005, 100011, 100012, 100015, 100017, 100021, 100022, 100028, 100032, 100034, 100037, 10005…

a) S701, Serial Numbers: 100005, 100011, 100012, 100015, 100017, 100021, 100022, 100028, 100032, 100034, 100037, 100053, 100055, 100059, 100060, 100068, 100075, 100079, 100082, 100083, 100090, 100095, 100098, 100103, 100106, 100116, 100119, 100122, 100124, 100128, 100132, 100135, 100139, 100141, 100148, 100149, 100205, 100208, 100211, 100213, 100221, 100230, 100231, 100232, 100234, 100236, 100238, 100239, 100245, 100247, 100251, 100252, 100254, 100255, 100262, 100265, 100269, 100303, 100305, 100306, 100311, 100348, 100366, 100377, 100378, 100380, 100383, 100390, 100391, 100392, 100393, 100394, 100395, 100396, 100399, 100400, 100401, 100403, 100405, 100406, 700002, 700003, 700004, 700005, 700006, 700008, 700010, 700021, 700022, 700023, 700024, 700025, 700026, 700027, 700028, 700029, 700031, 700036, 700037, 700039, 700040, 700042, 700043, 700044, 700046, 700047, 700048, 700049, 700050, 700051, 700055, 700062, 700067, 700081, 700083, 700084, 700086, 700089, 700091, 700092, 700093, 700095

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2001-2021%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.