FDA Device recall Z-0950-2021

EMBLEM S-ICD Model A209

FDA Device
Class I
terminated
Published 2021-02-17

On 2021-02-17 the FDA classified a Class I recall of EMBLEM S-ICD Model A209 by Boston Scientific, citing electrical overstress may lead to device malfunction.

Read the official FDA Device notice

Agency	FDA Device
Recall number	Z-0950-2021
Classification	Class I
Status	terminated
Initiated	2020-12-02
Published	2021-02-17
Last updated	2026-09-13 11:56 UTC
Company	Boston Scientific
Distribution	n/a

Product

EMBLEM S-ICD Model A209

Reason

Electrical overstress may lead to device malfunction.

Identifiers

code_info	Serial numbers: 104254, 104259, 104277, 104292, 104299, 104304, 104305, 104307, 104310, 104322, 104331, 104339, 1043… Serial numbers: 104254, 104259, 104277, 104292, 104299, 104304, 104305, 104307, 104310, 104322, 104331, 104339, 104340, 104341, 104348, 104349, 104351, 104355, 104356, 104357, 104365, 104430, 104440, 104562, 104736, 104778, 104812, 104813, 104816, 104879, 104892, 104905, 104906, 104914, 104915, 104920, 104926, 104931, 104934, 104935, 104938, 104939, 104943, 104946, 104947, 104964, 104967, 104970, 104972, 104988, 104989, 104991, 104995, 104999, 105014, 105016, 105018, 105019, 105020, 105021, 105022, 105023, 105025, 105027, 105039, 105040, 105041, 105046, 105048, 105053, 105054, 105056, 105059, 105063, 105064, 105066, 105070, 105073, 105074, 105078, 105080, 105086, 105089, 105116, 105117, 105130, 105131, 105132, 105143, 105162, 105163, 105164, 105167, 105169, 105179, 105188, 105192, 105200, 105201, 105217, 105218, 105236, 105238, 105239, 105245, 105248, 105272, 105276, 105304, 105309, 105310, 105312, 105319, 105321, 105325, 105328, 105329, 105330, 105332, 105347, 105348, 105350, 10535

code_info

Serial numbers: 104254, 104259, 104277, 104292, 104299, 104304, 104305, 104307, 104310, 104322, 104331, 104339, 1043…

Serial numbers: 104254, 104259, 104277, 104292, 104299, 104304, 104305, 104307, 104310, 104322, 104331, 104339, 104340, 104341, 104348, 104349, 104351, 104355, 104356, 104357, 104365, 104430, 104440, 104562, 104736, 104778, 104812, 104813, 104816, 104879, 104892, 104905, 104906, 104914, 104915, 104920, 104926, 104931, 104934, 104935, 104938, 104939, 104943, 104946, 104947, 104964, 104967, 104970, 104972, 104988, 104989, 104991, 104995, 104999, 105014, 105016, 105018, 105019, 105020, 105021, 105022, 105023, 105025, 105027, 105039, 105040, 105041, 105046, 105048, 105053, 105054, 105056, 105059, 105063, 105064, 105066, 105070, 105073, 105074, 105078, 105080, 105086, 105089, 105116, 105117, 105130, 105131, 105132, 105143, 105162, 105163, 105164, 105167, 105169, 105179, 105188, 105192, 105200, 105201, 105217, 105218, 105236, 105238, 105239, 105245, 105248, 105272, 105276, 105304, 105309, 105310, 105312, 105319, 105321, 105325, 105328, 105329, 105330, 105332, 105347, 105348, 105350, 10535

Status history

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

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0950-2021%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.