Medtr: Abre Venous System Recall - Incorrect Size Labeling
Medtronic recalls Abre Venous Self-expanding System due to incorrect size printed on device, packaging labeled correctly. Affected units may have size mismatch risks.
Lower-risk recall
Incorrect size printed on the device; packaging is labeled correctly.
Contact the company
What happened, in plain English
Medtronic is recalling its Abre Venous Self-expanding System because the device has the wrong size printed on it, while the packaging shows the correct size. This could lead to improper use if the wrong size is used during medical procedures. Read more at govinfonow.com/recall/63093-medtr-abre-venous-system-recall-incorrect-size-labeling.
Source Summary by GovInfoNow · govinfonow.com/recall/63093-medtr-abre-venous-system-recall-incorrect-size-labeling · Updated August 19, 2026 · FDA enforcement record: FDA #Z-1532-2021
Cite this page
“Medtr: Abre Venous System Recall - Incorrect Size Labeling.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/63093-medtr-abre-venous-system-recall-incorrect-size-labeling. Based on FDA recall #Z-1532-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1532-2021%22&limit=1).
Why it’s dangerous
The device has an incorrect size printed on it, which could lead to improper sizing during medical procedures. However, the packaging correctly labels the intended size, so the risk is limited to the device being used with the wrong size.
Who’s affected
Healthcare professionals using the device for venous procedures may be affected. Patients receiving the device are not directly at risk from this labeling issue.
How to tell if you have this one
Check for the catalog number REF AB9U16080090 on the device packaging. The UDI is 00643169796348 and lot number B086915.
- Brand
Medtronic- Category
Medical device
What to do — step by step
Check Device Labeling
Verify the size printed on the device matches the packaging label.
Where it went and when
Where it was distributed
Distributed nationwide; the notice names 6 states.
FDA distribution: “US Nationwide distribution in the states of NC, CO, CA, AZ, MT, MO.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Arizona, California, Colorado, Missouri, Montana, North Carolina.
Recall timeline
FDA terminated this recall 3.1 years 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.
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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-1532-2021 (March 16, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1532-2021 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.