Arrow Bipolar Balloon Electrode Catheter Recall: No 510K Marketing

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Contact the company & request your remedy

Recalling firmArrow International Inc2400 Bernville Rd · Reading, PA 19605-9607

No email on file — write to the address above instead.

✎ GovInfoNow plain-language explainer

What happened, in plain English

Arrow is recalling a bipolar balloon electrode catheter used in temporary medical procedures because it was marketed without the required regulatory approval (510K). This could pose risks if used without proper clearance.

Why it’s dangerous

This catheter was marketed without the necessary regulatory clearance (510K) for medical use. Without proper approval, there is uncertainty about its safety and effectiveness in medical procedures.

Who’s affected

Healthcare professionals who use this catheter for electrophysiology studies may be affected. Patients receiving temporary cardiac procedures with this device are at risk if the product lacks regulatory approval.

How to tell if you have this one

Check for product code AI-07154 on the catheter. This device was sold with lot number 16F19J0109 for temporary electrophysiology procedures.

Brand
Arrow
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Product Code
Look for product code AI-07154 on the catheter packaging or device.

✎ GovInfoNow

Questions people ask

Why is this catheter being recalled?

This catheter was marketed without the required regulatory approval (510K) for medical use in electrophysiology studies.

What is the product code for this recalled catheter?

The product code is AI-07154.

Is there a remedy for this recall?

The recall record does not specify a remedy.

Take action

Contact Arrow

We’ve drafted a message you can send Arrow to request your refund or repair — edit it as you like.

✉️ Open in email

Subject: Recall Z-2070-2021 — Arrow Arrow

Hello,

I own a Arrow that is covered by recall Z-2070-2021 from Arrow.

I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this?

Thank you.

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Where this comes from

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-2070-2021 (May 19, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2070-2021 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.

Arrow International Inc recalls Arrow Bipolar Balloon Electrode Catheter 5 Fr. 105 cm, Product Code: AI-07154 - Product Usage: intended for temporary

Recall notice