UnratedMedical device recall · FDA · Published May 19, 2021
Arrow Pacing Catheter Kit: Marketing Without 510K Clearance
Arrow recalls a specific pacing catheter kit due to being marketed without proper FDA 510K clearance. This device is used in electrophysiology studies. Affected units have specific lot numbers.
“Arrow Pacing Catheter Kit: Marketing Without 510K Clearance.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/62514-arrow-pacing-catheter-kit-marketing-without-510k-clearance. Based on FDA recall #Z-2068-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2068-2021%22&limit=1).
The FDA announced on May 19, 2021, that Arrow International Inc. is recalling the Arrow Pacing Catheter Kit-Bipolar Electrode Catheter because it was marketed without required clearance. The recall affects 48 units distributed nationwide in Florida, Idaho, Illinois, New York, Ohio, and Texas.
The product was marketed without a 510(k) clearance, according to the FDA. The device is intended for temporary use in electrophysiology studies for intracardiac stimulation and/or ECG recording.
Context
GovInfoNow's records show Arrow International Inc. has 52 other recalls on record since June 1, 2017. Other recent recalls of similar products include Arrow Arterial Kits and Trays (July 26, 2024), Arrow FiberOptix Intra-Aortic Balloon Catheter Kit (April 29, 2024), ARROW QuickFlash Radial Artery Catheter (Feb. 12, 2024), Medline ARTHROGRAM TRAY and TOL NEURO ANGIO PACK (Feb. 25, 2026), Medline Angio Cath Pack Kits (Feb. 25, 2026), and Arrow Recalls Catheter Kits with Possible Drug Contamination Risk (April 21, 2026).
How to tell if you have this one
Check the product code AI-05210 on the kit. Affected units have specific lot numbers: 16F16F0057, 16F19D0027, 16F18B0040, 16F19E0157, 16F18E0121, 16F19F0093, 16F18F0058, 16F19G0066, 16F19C0082.
Brand
Arrow
Category
Medical device
FDA recall event · 4 products
All 4 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
Classification
Class II
Status
Ongoing
Distribution
US Nationwide distribution in the states of FL, ID, IL, NY, OH, TX.
Recall number
Product, codes & lots
Quantity
Z-2068-2021
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.; Lot Numbers: 16F16F0057 16F19D0027 16F18B0040 16F19E0157 16F18E0121 16F19F0093 16F18F0058 16F19G0066 16F19C0082
48 units
Z-2069-2021
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.; Lot Numbers: 16F20C0035 16F20F0124
5 units
Z-2070-2021
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.; Lot Numbers: 16F19J0109
4 units
Z-2071-2021
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.; Lot Numbers: 23F20A0230 23F20E0004 23F20E0094
15 units
Based on the official FDA remedy
What to do — step by step
Check Product Lot Numbers
Look for lot numbers listed: 16F16F0057, 16F19D0027, 16F18B0040, 16F19E0157, 16F18E0121, 16F19F0093, 16F18F0058, 16F19G0066, 16F19C0082.
Where it went and when
Where it was distributed
Distributed nationwide; the notice names 6 states.
Named in the notice
Covered by “nationwide”
Not listed
FDA distribution: “US Nationwide distribution in the states of FL, ID, IL, NY, OH, TX.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Florida, Idaho, Illinois, New York, Ohio, Texas.
Recall timeline
FDA published this recall 2 months after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-2068-2021 (May 19, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2068-2021 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.