Recall events
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Event 88120
Event summary
Timeline bucket May 19, 2021
Product types Device
Classifications Class II
Statuses Ongoing
Recalling firm wording Arrow International 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
Arrow Pacing Catheter Kit-Bipolar Electrode Catheter 5 Fr. 110 cm, Product Code: AI-05210 - Product Usage: intended for temporary use in electrophysiology studies for intracardiac stimulation and/or ECG recording.
Z-2068-2021
Recall number Z-2068-2021
Initiated May 19, 2021
Classification Class II
Status Ongoing
Quantity 48 units
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
Marketed without a 510K
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
No Marketing Application
Enrichment source openFDA Device Recall
Exact join Official recall number Z-2068-2021
Source locator 0001-device-recall-0001-of-0001.json.zip#results[41274]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Marketed without a 510K
Code information Lot Numbers: 16F16F0057 16F19D0027 16F18B0040 16F19E0157 16F18E0121 16F19F0093 16F18F0058 16F19G0066 16F19C0082
Distribution pattern US Nationwide distribution in the states of FL, ID, IL, NY, OH, TX.
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[12318]
FDA event record
· Exact recall-number query on openFDA
device · product 2 of 4
Arrow Temporary Pacing Catheter/Introducer Kit 6Fr. pacing catheter 7Fr. introducer Product Code: AI-06210-IK - Product Usage: intended for temporary use in electrophysiology studies for intracardiac stimulation and/or ECG recording.
Z-2069-2021
Recall number Z-2069-2021
Initiated May 19, 2021
Classification Class II
Status Ongoing
Quantity 5 units
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
Marketed without a 510K
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
No Marketing Application
Enrichment source openFDA Device Recall
Exact join Official recall number Z-2069-2021
Source locator 0001-device-recall-0001-of-0001.json.zip#results[6026]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Marketed without a 510K
Code information Lot Numbers: 16F20C0035 16F20F0124
Distribution pattern US Nationwide distribution in the states of FL, ID, IL, NY, OH, TX.
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[13366]
FDA event record
· Exact recall-number query on openFDA
device · product 3 of 4
Arrow Bipolar Balloon Electrode Catheter 5 Fr. 105 cm, Product Code: AI-07154 - Product Usage: intended for temporary use in electrophysiology studies for intracardiac stimulation and/or ECG recording.
Z-2070-2021
Recall number Z-2070-2021
Initiated May 19, 2021
Classification Class II
Status Ongoing
Quantity 4 units
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
Marketed without a 510K
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
No Marketing Application
Enrichment source openFDA Device Recall
Exact join Official recall number Z-2070-2021
Source locator 0001-device-recall-0001-of-0001.json.zip#results[83]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Marketed without a 510K
Code information Lot Numbers: 16F19J0109
Distribution pattern US Nationwide distribution in the states of FL, ID, IL, NY, OH, TX.
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[10986]
FDA event record
· Exact recall-number query on openFDA
device · product 4 of 4
Arrow Temporary Pacing Catheter/Introducer Kit 5Fr. pacing catheter 6 Fr. introducer Product Code: AI-07155-IK - Product Usage: intended for temporary use in electrophysiology studies for intracardiac stimulation and/or ECG recording.
Z-2071-2021
Recall number Z-2071-2021
Initiated May 19, 2021
Classification Class II
Status Ongoing
Quantity 15 units
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
Marketed without a 510K
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
No Marketing Application
Enrichment source openFDA Device Recall
Exact join Official recall number Z-2071-2021
Source locator 0001-device-recall-0001-of-0001.json.zip#results[17797]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Marketed without a 510K
Code information Lot Numbers: 23F20A0230 23F20E0004 23F20E0094
Distribution pattern US Nationwide distribution in the states of FL, ID, IL, NY, OH, TX.
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[12237]
FDA event record
· Exact recall-number query on openFDA
