Recall events
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Event 85398
Event summary
Timeline bucket December 04, 2019
Product types Device
Classifications Class I
Statuses Terminated
Recalling firm wording Argon Medical Devices, 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
2 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 2
0.035"(.89mm)x80 cm guidewire. Model 114135080. Soft Tip 3.5cm. REF/UDI: 114135080/(01)208863333008067. RxOnly STERILE EO
Z-1791-2020
Recall number Z-1791-2020
Initiated December 04, 2019
Classification Class I
Status Terminated
Quantity 1690 units
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
The stiffness of the soft end of the guidewire caused tissue perforation.
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Employee error
Enrichment source openFDA Device Recall
Exact join Official recall number Z-1791-2020
Source locator 0001-device-recall-0001-of-0001.json.zip#results[39601]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall The stiffness of the soft end of the guidewire caused tissue perforation.
Code information Guidewire Model 114135080; LOT numbers: 11235895, 11234476, 11237014, and 11240602.
Distribution pattern No US consignees. OUS - Sweden, Norway, Denmark, Greece, Slovenia, Turkey, Hong Kong, England
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[31376]
FDA event record
· Exact recall-number query on openFDA
device · product 2 of 2
0.035"(.89mm)x150 cm guidewire. Model 114135150. Soft Tip 3.5cm. REF/UDI: 114135150/(01)20886333008074. RxOnly.STERILE EO
Z-1792-2020
Recall number Z-1792-2020
Initiated December 04, 2019
Classification Class I
Status Terminated
Quantity 1190 units
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
The stiffness of the soft end of the guidewire caused tissue perforation.
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Employee error
Enrichment source openFDA Device Recall
Exact join Official recall number Z-1792-2020
Source locator 0001-device-recall-0001-of-0001.json.zip#results[44746]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall The stiffness of the soft end of the guidewire caused tissue perforation.
Code information Guidewire Model 114135150; LOT numbers: 11248718, 11251204, 11260495. 11268741, 11242667, 11241250 and 11239540
Distribution pattern No US consignees. OUS - Sweden, Norway, Denmark, Greece, Slovenia, Turkey, Hong Kong, England
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[30198]
FDA event record
· Exact recall-number query on openFDA
