Arrow Bipolar Electrode Catheter: Incorrect Expiration Date Label
Arrow recalls bipolar electrode catheters with incorrect expiration dates. Products labeled with wrong use-by date may expire before intended use. Consumers should check product labels for correct expiration date.
Lower-risk recall
Products are labeled with an incorrect expiration date
Contact the company
What happened, in plain English
Arrow is recalling bipolar electrode catheters that have an incorrect expiration date label. This could mean the product expires before it's supposed to, potentially causing issues if used after the wrong date. Read more at govinfonow.com/recall/70280-arrow-bipolar-electrode-catheter-incorrect-expiration-date-label.
Source Summary by GovInfoNow · govinfonow.com/recall/70280-arrow-bipolar-electrode-catheter-incorrect-expiration-date-label · Updated August 20, 2026 · FDA enforcement record: FDA #Z-3197-2018
Cite this page
“Arrow Bipolar Electrode Catheter: Incorrect Expiration Date Label.” GovInfoNow, updated August 20, 2026. https://govinfonow.com/recall/70280-arrow-bipolar-electrode-catheter-incorrect-expiration-date-label. Based on FDA recall #Z-3197-2018 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3197-2018%22&limit=1).
Why it’s dangerous
The catheter has an incorrect expiration date label, which could lead to the product expiring before it's intended to be used. This might cause the catheter to be used after it's no longer safe or effective.
Who’s affected
Users of Arrow electrophysiology catheters for temporary heart studies may be affected. Those who have the product with the specific model and batch number are most at risk.
How to tell if you have this one
Check for the product code AI-062:10-S and batch number 16F18A0010 on the catheter label. The expiration date should be 2023-12-31 as per the label.
- Brand
Arrow- Category
Medical device
What to do — step by step
Check Expiration Date
Verify the expiration date on the catheter label matches the use-by date of 2023-12-31.
Where it went and when
Where it was distributed
Distributed in Pennsylvania.
FDA distribution: “US in the state of PA” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: Pennsylvania.
Recall timeline
FDA terminated this recall 11 months after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
Questions people ask
Is this catheter dangerous if used after the wrong date?
The recall is due to an incorrect expiration date label, not an immediate safety hazard. Using it after the wrong date could lead to ineffective use.
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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-3197-2018 (July 30, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-3197-2018 to see it in context.
- Plain-language summary written by qwen3:4b on August 20, 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.