ARROW Endurance Catheter System Recall: Potential for separation or leakage
ARROW recalls specific catheter systems due to potential separation or leakage. Affected models include ASK-00620-MSH, ASK-00620-TMC, and others with unique UDI batch numbers. Stop using if you have these items.
Use caution until it’s fixed
Potential for catheter separation or leakage
Contact the company
What happened, in plain English
ARROW is recalling several types of endurable catheter systems because they might separate or leak. This could cause infections or other complications if the catheter isn't properly secured. If you own any of the listed models, you should stop using them immediately. Read more at govinfonow.com/recall/58147-arrow-endurance-catheter-system-recall-potential-for-separation-or-leakage.
Source Summary by GovInfoNow · govinfonow.com/recall/58147-arrow-endurance-catheter-system-recall-potential-for-separation-or-leakage · Updated August 19, 2026 · FDA enforcement record: FDA #Z-1826-2023
Cite this page
“ARROW Endurance Catheter System Recall: Potential for separation or leakage.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/58147-arrow-endurance-catheter-system-recall-potential-for-separation-or-leakage. Based on FDA recall #Z-1826-2023 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1826-2023%22&limit=1).
Why it’s dangerous
The catheter system may separate or leak due to a manufacturing defect, which could lead to infection or other complications if the catheter isn't properly secured. This risk is higher for patients who use the catheter for extended periods.
Who’s affected
People who use medical catheters for extended periods, such as those in hospitals or home care settings, are most at risk. Patients with catheters that have the listed product codes or UDI batch numbers are affected.
How to tell if you have this one
Check the product code on the catheter system (e.g., ASK-00620-MSH, ASK-00620-TMC) and the UDI batch number listed in the recall notice. The specific batch numbers are detailed in the recall record.
- Brand
ARROW- Product
ARROW Endurance Extended Dwell Peripheral Catheter System- Category
Medical device
What to do — step by step
Check Product Details
Look for the product code (e.g., ASK-00620-MSH) and UDI batch number on the catheter system.
Stop Using Immediately
If you have the affected product codes or UDI batch numbers, stop using the catheter system right away.
Where it went and when
Where it was distributed
Distributed nationwide, and outside the U.S.
FDA distribution: “Nationwide distribution. International distribution to Canada.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide, and outside the U.S.
Recall timeline
FDA published this recall 40 days after the firm started it.
- Firm started the recall
- FDA classified it Class I
- Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
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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-1826-2023 (May 19, 2023) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1826-2023 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.