Recall events
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Event 94270
Event summary
Timeline bucket March 08, 2024
Product types Device
Classifications Class I
Statuses Ongoing
Recalling firm wording ROUTE 92 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
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
Route 92 Medical Full Length 070 Access System, REF 7002, Rxonly, SterileEO. Used for Introduction of interventional devices into the neurovasculature.
Z-1610-2024
Recall number Z-1610-2024
Initiated March 08, 2024
Classification Class I
Status Ongoing
Quantity 10 units
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
Their is the potential for distal tip separation at the proximal marker band of the delivery catheters.
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Process control
Enrichment source openFDA Device Recall
Exact join Official recall number Z-1610-2024
Source locator 0001-device-recall-0001-of-0001.json.zip#results[5196]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Their is the potential for distal tip separation at the proximal marker band of the delivery catheters.
Code information UDI: 00853799007473/ Lot # 23051901
Distribution pattern US: AL AZ CA DE FL GA IA IL IN KY LA MA MD MI MN MO NC ND NJ NY OH OR PA RI SD TN TX UT VA WV OUS: New Zealand
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[34561]
FDA event record
· Exact recall-number query on openFDA
device · product 2 of 5
Route 92 Medical, Full Length 070 Reperfusion System, REF: 7001, Rxonly, SterileEO. Used for Introduction of interventional devices into the neurovasculature.
Z-1611-2024
Recall number Z-1611-2024
Initiated March 08, 2024
Classification Class I
Status Ongoing
Quantity 750 units
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
Their is the potential for distal tip separation at the proximal marker band of the delivery catheters
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Process control
Enrichment source openFDA Device Recall
Exact join Official recall number Z-1611-2024
Source locator 0001-device-recall-0001-of-0001.json.zip#results[22845]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Their is the potential for distal tip separation at the proximal marker band of the delivery catheters
Code information UDI: 00853799007497/ Lot # 223060102, 24010102, 23070501, 24010903, 23082802 24011606 , 23100404, 24012403 , 23110901
Distribution pattern US: AL AZ CA DE FL GA IA IL IN KY LA MA MD MI MN MO NC ND NJ NY OH OR PA RI SD TN TX UT VA WV OUS: New Zealand
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[36159]
FDA event record
· Exact recall-number query on openFDA
device · product 3 of 5
Route 92 Medical, 070 Access System, REF 1004, Rxonly , Sterile EO. Used for introduction of interventional devices into the neurovasculature.
Z-1612-2024
Recall number Z-1612-2024
Initiated March 08, 2024
Classification Class I
Status Ongoing
Quantity 117 units
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
Their is the potential for distal tip separation at the proximal marker band of the delivery catheters
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Process control
Enrichment source openFDA Device Recall
Exact join Official recall number Z-1612-2024
Source locator 0001-device-recall-0001-of-0001.json.zip#results[5197]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Their is the potential for distal tip separation at the proximal marker band of the delivery catheters
Code information UDI: 00853799007442/ Lot # 23061601 24010306, 23081802, 24011801, 23100601, 24020801, 23102601
Distribution pattern US: AL AZ CA DE FL GA IA IL IN KY LA MA MD MI MN MO NC ND NJ NY OH OR PA RI SD TN TX UT VA WV OUS: New Zealand
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[36142]
FDA event record
· Exact recall-number query on openFDA
device · product 4 of 5
Route 92 Medical, Tenzing 7 Delivery Catheter, REF 1005, Rx Only, Sterile EO. Used for introduction of interventional devices into the neurovasculature.
Z-1613-2024
Recall number Z-1613-2024
Initiated March 08, 2024
Classification Class I
Status Ongoing
Quantity 200 units
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
Their is the potential for distal tip separation at the proximal marker band of the delivery catheters
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Process control
Enrichment source openFDA Device Recall
Exact join Official recall number Z-1613-2024
Source locator 0001-device-recall-0001-of-0001.json.zip#results[10140]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Their is the potential for distal tip separation at the proximal marker band of the delivery catheters
Code information UDI: 00853799007534/ Lot # 23033001, 23073101, 23070305, 23081707
Distribution pattern US: AL AZ CA DE FL GA IA IL IN KY LA MA MD MI MN MO NC ND NJ NY OH OR PA RI SD TN TX UT VA WV OUS: New Zealand
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[32537]
FDA event record
· Exact recall-number query on openFDA
device · product 5 of 5
Route 92 Medical 070 Reperfusion System, REF 1003, Rxonly, SterileEO. Used for introduction of interventional devices into the neurovasculature and aspiration of thrombus in ischemic stroke patients.
Z-1614-2024
Recall number Z-1614-2024
Initiated March 08, 2024
Classification Class I
Status Ongoing
Quantity 19 units
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
Their is the potential for distal tip separation at the proximal marker band of the delivery catheters
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Process control
Enrichment source openFDA Device Recall
Exact join Official recall number Z-1614-2024
Source locator 0001-device-recall-0001-of-0001.json.zip#results[28807]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Their is the potential for distal tip separation at the proximal marker band of the delivery catheters
Code information UDI: 00853799007169/ Lot # 23112702 and 23112901
Distribution pattern US: AL AZ CA DE FL GA IA IL IN KY LA MA MD MI MN MO NC ND NJ NY OH OR PA RI SD TN TX UT VA WV OUS: New Zealand
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[32578]
FDA event record
· Exact recall-number query on openFDA
