Recall events
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Event 78323
Event summary
Timeline bucket October 04, 2017
Product types Device
Classifications Class II
Statuses Terminated
Recalling firm wording Boston Scientific Corporation
Dossier provenance
Source snapshots represented here
openFDA Device Enforcement
Report-date coverage
June 20, 2012–July 08, 2026
Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
openFDA Device Recall
event_date_initiated coverage
June 01, 1997–June 30, 2026
Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.
How coverage and grouping work
Complete imported group
Every recalled product in this event
5 official enforcement rows
Product dates, classifications, firms, and source wording remain attached to their individual rows.
Opening this dossier never hides products that did not match a prior timeline filter.
device · product 1 of 5
RESONATE EL ICD VR, Model D432, Sterile.
Z-0077-2018
Recall number Z-0077-2018
Initiated October 04, 2017
Classification Class II
Status Terminated
Quantity 5 devices
App-derived interpretation
Device software or design
reason.device_software_design · v1.0.0
incorrect firmware
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Unknown
An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.
Enrichment source openFDA Device Recall
Exact join Official recall number Z-0077-2018
Source locator 0001-device-recall-0001-of-0001.json.zip#results[15993]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall The devices have an incorrect firmware configuration.
Code information Serial numbers 224020, 224209, 224322, 224366, and 224506
Distribution pattern The devices were distributed to medical facilities located in MN and OH. There was no foreign/government/military distribution.
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[26529]
FDA event record
· Exact recall-number query on openFDA
device · product 2 of 5
RESONATE EL ICD DR, Model D433, Sterile.
Z-0078-2018
Recall number Z-0078-2018
Initiated October 04, 2017
Classification Class II
Status Terminated
Quantity 12 devices
App-derived interpretation
Device software or design
reason.device_software_design · v1.0.0
incorrect firmware
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Unknown
An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.
Enrichment source openFDA Device Recall
Exact join Official recall number Z-0078-2018
Source locator 0001-device-recall-0001-of-0001.json.zip#results[50261]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall The devices have an incorrect firmware configuration.
Code information Serial numbers 530802, 531123, 531237, 531292, 531301, 531446, 531492, 531520, 531536, 531539, 531545, and 531767.
Distribution pattern The devices were distributed to medical facilities located in MN and OH. There was no foreign/government/military distribution.
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[25345]
FDA event record
· Exact recall-number query on openFDA
device · product 3 of 5
VIGILANT X4 CRT-D, Model G247, Sterile. Cardiac Resynchronization Therapy Defibrillators (CRT-Ds) are indicated for patients with heart failure who receive stable optimal pharmacologic therapy (OPT) for heart failure and who meet any one of the following classifications: (1) Moderate to severe heart failure (NYHA Class III-IV) with EF d 35% and QRS duration e 120 ms; (2) Left bundle branch block (LBBB) with QRS duration e 130 ms, EF d 30%, and mild (NYHA Class II) ischemic or nonischemic heart failure or asymptomatic (NYHA Class I) ischemic heart failure.
Z-0079-2018
Recall number Z-0079-2018
Initiated October 04, 2017
Classification Class II
Status Terminated
Quantity 4 devices
App-derived interpretation
Device software or design
reason.device_software_design · v1.0.0
incorrect firmware
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Unknown
An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.
Enrichment source openFDA Device Recall
Exact join Official recall number Z-0079-2018
Source locator 0001-device-recall-0001-of-0001.json.zip#results[39160]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall The devices have an incorrect firmware configuration.
Code information Serial numbers 174170, 174349, 174598, and 174606.
Distribution pattern The devices were distributed to medical facilities located in MN and OH. There was no foreign/government/military distribution.
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[26548]
FDA event record
· Exact recall-number query on openFDA
device · product 4 of 5
MOMENTUM X4 CRT-D, Model G138, Sterile.
Z-0080-2018
Recall number Z-0080-2018
Initiated October 04, 2017
Classification Class II
Status Terminated
Quantity 4 devices
App-derived interpretation
Device software or design
reason.device_software_design · v1.0.0
incorrect firmware
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Unknown
An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.
Enrichment source openFDA Device Recall
Exact join Official recall number Z-0080-2018
Source locator 0001-device-recall-0001-of-0001.json.zip#results[15989]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall The devices have an incorrect firmware configuration.
Code information Serial numbers 377292, 377337, 377341, and 377347
Distribution pattern The devices were distributed to medical facilities located in MN and OH. There was no foreign/government/military distribution.
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[19854]
FDA event record
· Exact recall-number query on openFDA
device · product 5 of 5
RESONATE X4 CRT-D, Model G447, Sterile.
Z-0081-2018
Recall number Z-0081-2018
Initiated October 04, 2017
Classification Class II
Status Terminated
Quantity 11 devices
App-derived interpretation
Device software or design
reason.device_software_design · v1.0.0
incorrect firmware
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Unknown
An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.
Enrichment source openFDA Device Recall
Exact join Official recall number Z-0081-2018
Source locator 0001-device-recall-0001-of-0001.json.zip#results[26684]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall The devices have an incorrect firmware configuration.
Code information Serial numbers 174030, 174900, 174995, 175178, 175328, 175329, 175396, 175440, 175503, 175545, and 175606
Distribution pattern The devices were distributed to medical facilities located in MN and OH. There was no foreign/government/military distribution.
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[19841]
FDA event record
· Exact recall-number query on openFDA
