Recall events
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Event 85197
Event summary
Timeline bucket February 25, 2020
Product types Device
Classifications Class II
Statuses Terminated
Recalling firm wording Acutus Medical Inc
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
4 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 4
Rhythm Xience Guider Catheter Introducer with Lancer Intergrated Dilator/Transseptal Needle, Ref 112852, Sterile EO, RxOnly
Z-1768-2020
Recall number Z-1768-2020
Initiated February 25, 2020
Classification Class II
Status Terminated
Quantity 108 units
App-derived interpretation
Foreign material or chemical contamination
reason.foreign_material_chemical_contamination · v1.0.0
foreign material
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Process design
Enrichment source openFDA Device Recall
Exact join Official recall number Z-1768-2020
Source locator 0001-device-recall-0001-of-0001.json.zip#results[50490]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
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Reason for recall It has been determined that the manufacturing process may have left foreign material particulates on the finished device. This could result in a range of event from procedure delay to pulmonary embolism.
Code information Affected Lot Numbers/Expiration Date: 19040503 /April 2020 19052007 /May 2020 19061317 /June 2020
Distribution pattern US: CA,SC, AZ OUS: None
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[30966]
FDA event record
· Exact recall-number query on openFDA
device · product 2 of 4
Acutus Medical AcQGuide Mini Fixed-Curve Introducer with AcQCros QX Integrated Dilator/Transseptal Needle, Ref: 112852 Sterile EO, RxOnly
Z-1769-2020
Recall number Z-1769-2020
Initiated February 25, 2020
Classification Class II
Status Terminated
Quantity 268 units
App-derived interpretation
Foreign material or chemical contamination
reason.foreign_material_chemical_contamination · v1.0.0
foreign material
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Process design
Enrichment source openFDA Device Recall
Exact join Official recall number Z-1769-2020
Source locator 0001-device-recall-0001-of-0001.json.zip#results[39527]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall It has been determined that the manufacturing process may have left foreign material particulates on the finished device. This could result in a range of event from procedure delay to pulmonary embolism.
Code information Affected Lot Numbers/Expiration Date: 19101021 /October 2020 19103124 /October 2020 19121604 /December 2020
Distribution pattern US: CA,SC, AZ OUS: None
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[30150]
FDA event record
· Exact recall-number query on openFDA
device · product 3 of 4
Rhythm Xience Flextra Steerable Introducer with Lancer Integrated Dilator/Transseptal Needle, REF: 122852, Sterile EO, RxOnly
Z-1770-2020
Recall number Z-1770-2020
Initiated February 25, 2020
Classification Class II
Status Terminated
Quantity 30 units
App-derived interpretation
Foreign material or chemical contamination
reason.foreign_material_chemical_contamination · v1.0.0
foreign material
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Process design
Enrichment source openFDA Device Recall
Exact join Official recall number Z-1770-2020
Source locator 0001-device-recall-0001-of-0001.json.zip#results[32940]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall It has been determined that the manufacturing process may have left foreign material particulates on the finished device. This could result in a range of event from procedure delay to pulmonary embolism.
Code information Affected Lot Numbers/Expiration Date: 19052006/ May 2020 19061318/ June 2020
Distribution pattern US: CA,SC, AZ OUS: None
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[31391]
FDA event record
· Exact recall-number query on openFDA
device · product 4 of 4
Acutus Medical AcQGuide Flex Steerable Introducer with AcQcross QX Integrated Dilator/Transseptal Needle, REF: 122852, SterileEO RxOnly
Z-1771-2020
Recall number Z-1771-2020
Initiated February 25, 2020
Classification Class II
Status Terminated
Quantity 5 units
App-derived interpretation
Foreign material or chemical contamination
reason.foreign_material_chemical_contamination · v1.0.0
foreign material
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Process design
Enrichment source openFDA Device Recall
Exact join Official recall number Z-1771-2020
Source locator 0001-device-recall-0001-of-0001.json.zip#results[9147]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall It has been determined that the manufacturing process may have left foreign material particulates on the finished device. This could result in a range of event from procedure delay to pulmonary embolism.
Code information Affected Lot Numbers/Expiration Date: 19101020 /October 2020
Distribution pattern US: CA,SC, AZ OUS: None
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[31283]
FDA event record
· Exact recall-number query on openFDA
