FDA Device recall Z-2002-2021

VALITUDE CRT-P pacemaker, Models: a) U125 b) U128

FDA Device
Class II
ongoing
Published 2021-07-14

On 2021-07-14 the FDA classified a Class II recall of VALITUDE CRT-P pacemaker, Models: a) U125 b) U128 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-2002-2021
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

VALITUDE CRT-P pacemaker, Models: a) U125 b) U128

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) U125, Serial Numbers: 100009, 100057, 100074, 100257, 100521, 700037, 700061, 700068, 700074, 700172, 700179, 70019… a) U125, Serial Numbers: 100009, 100057, 100074, 100257, 100521, 700037, 700061, 700068, 700074, 700172, 700179, 700190, 700253, 702556, 702777, 702999, 703683, 703806, 704048, 707332, 707470, 707508, 100002, 100003, 100004, 100005, 100006, 100007, 100008, 100010, 100011, 100013, 100015, 100020, 100024, 100026, 100028, 100029, 100033, 100050, 100054, 100058, 100062, 100063, 100066, 100067, 100068, 100069, 100071, 100076, 100079, 100081, 100084, 100085, 100086, 100091, 100102, 100106, 100110, 100133, 100136, 100146, 100148, 100149, 100150, 100157, 100159, 100163, 100164, 100165, 100171, 100175, 100188, 100192, 100199, 100200, 100201, 100202, 100203, 100205, 100208, 100209, 100210, 100211, 100213, 100214, 100215, 100216, 100217, 100218, 100219, 100220, 100222, 100224, 100226, 100228, 100231, 100234, 100235, 100237, 100244, 100245, 100248, 100249, 100250, 100251, 100253, 100256, 100265, 100267, 100268, 100272, 100274, 100275, 100277, 100279, 100283, 100284, 100290, 100308, 100317, 100391

code_info

a) U125, Serial Numbers: 100009, 100057, 100074, 100257, 100521, 700037, 700061, 700068, 700074, 700172, 700179, 70019…

a) U125, Serial Numbers: 100009, 100057, 100074, 100257, 100521, 700037, 700061, 700068, 700074, 700172, 700179, 700190, 700253, 702556, 702777, 702999, 703683, 703806, 704048, 707332, 707470, 707508, 100002, 100003, 100004, 100005, 100006, 100007, 100008, 100010, 100011, 100013, 100015, 100020, 100024, 100026, 100028, 100029, 100033, 100050, 100054, 100058, 100062, 100063, 100066, 100067, 100068, 100069, 100071, 100076, 100079, 100081, 100084, 100085, 100086, 100091, 100102, 100106, 100110, 100133, 100136, 100146, 100148, 100149, 100150, 100157, 100159, 100163, 100164, 100165, 100171, 100175, 100188, 100192, 100199, 100200, 100201, 100202, 100203, 100205, 100208, 100209, 100210, 100211, 100213, 100214, 100215, 100216, 100217, 100218, 100219, 100220, 100222, 100224, 100226, 100228, 100231, 100234, 100235, 100237, 100244, 100245, 100248, 100249, 100250, 100251, 100253, 100256, 100265, 100267, 100268, 100272, 100274, 100275, 100277, 100279, 100283, 100284, 100290, 100308, 100317, 100391

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-2002-2021%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.