Class II U.S. Food and Drug Administration

Medtronic Inc Abre Venous Self-Expanding Stent System, Model numbers AB9G14120090 recall: Stents may be impacted by a Nitinol anomaly which causes a reduced stent

Recall published 9 months ago

Stents may be impacted by a Nitinol anomaly which causes a reduced stent diameter when deployed and corresponding reduced radial force. Issue may result in stent migration.

The hazard: Device safety concern

A device recall was filed for this product. For anything implanted or relied on daily, the clinician comes before the paperwork.

What the notice says: Stents may be impacted by a Nitinol anomaly which causes a reduced stent diameter when deployed and corresponding reduced radial force. Issue may result in stent migration.

Why it matters: The FDA recorded an enforcement action against this device. Most device recalls are corrections rather than removals, so the device often stays in use while the manufacturer issues a fix.

Recall details

Recall number
Z-1098-2026
Published
January 21, 2026
Risk level
Class II
Status
Ongoing
Issued by
U.S. Food and Drug Administration
Brand
Medtronic Inc
Product type
Medical devices
Units affected
442
Distribution
Nationwide
Made in
United States
Lot / code info
UDI-DI (GTIN): 00763000547332 00763000547271 00763000547318 00763000547264 00643169796225 00643169796300 00643169796294 00643169796232 00643169796287 00763000547325 00643169796300 00763000547257 Serial/Lot numbers C112511 C113253 C113795 C117416 C117482 C121084 C123953 C133327 C133329 C134478 C138060 C150325
UPC codes
00763000547332, 00763000547271, 00763000547318, 00763000547264, 00643169796225, 00643169796300, 00643169796294, 00643169796232, 00643169796287, 00763000547325, 00763000547257

Products covered by this recall

Abre Venous Self-Expanding Stent System, Model numbers AB9G14120090 AB9G12100090 AB9G14080090 AB9G12080090 AB9U12060090 AB9U14100090 AB9U14080090 AB9U12080090 AB9U14060090 AB9G14100090 AB9G12060090

Check your product

The notice names 12 codes you can read straight off the package. Type the one printed on yours and the list below narrows to it.

UPC / barcode

Read the twelve digits under the barcode on the package.

  • 00763000547332
  • 00763000547271
  • 00763000547318
  • 00763000547264
  • 00643169796225
  • 00643169796300
  • 00643169796294
  • 00643169796232
  • 00643169796287
  • 00763000547325
  • 00763000547257

Model or item number

On the rating label, the box or the instruction sheet.

  • AB9G14120090 AB9G12100090 AB9G14080090 AB9G12080090

Codes are lifted verbatim from the FDA — Device enforcement notice. A code that is missing here may still be covered — the official notice is the complete list.

What to do about Device

Medtronic Inc — A device recall was filed for this product. For anything implanted or relied on daily, the clinician comes before the paperwork.

  1. Match the model, catalogue, lot and serial numbers on your device against the identifiers on this page.
  2. If the device is implanted or you depend on it daily, speak to your clinician before changing how you use it.
  3. Ask the supplier or clinic that provided it what the remedy is in your case.
  4. If you are a facility, quarantine affected stock and log the correction.

Claiming on a recalled device

Device recalls are tracked by serial and lot number, so your claim moves faster if you lead with those.

  • Have the model, catalogue, lot and serial numbers ready before you call — they are on the device label or its box.
  • Ask explicitly whether your unit is in the affected range; many recalls cover only part of a model line.
  • If you need the device daily, ask what interim arrangement they offer while the remedy is carried out.
  • Log the date, the name and the reference number of every call. Device recalls can run for months.

Company contact: Medtronic Inc — 4600 Nathan Ln N, Plymouth, MN, 55442-2890

The official notice

This page summarises a notice published by U.S. Food and Drug Administration. The agency notice is the authoritative version — read it before you act, and treat it as the final word if anything here looks different.

Open the FDA — Device enforcement record U.S. Food and Drug Administration recalls

Questions people ask about this recall

Why was Medtronic Inc medical devices recalled?

Stents may be impacted by a Nitinol anomaly which causes a reduced stent diameter when deployed and corresponding reduced radial force. Issue may result in stent migration. Stents may be impacted by a Nitinol anomaly which causes a reduced stent diameter when deployed and corresponding reduced radial force. Issue may result in stent migration.

How do I know if I have the recalled product?

Match the codes printed on your package against the notice: UPC 00763000547332, 00763000547271, 00763000547318; model number AB9G14120090 AB9G12100090 AB9G14080090 AB9G12080090. If the code on your package is not on that list, your unit is outside the recall.

What should I do with it right now?

Match the model, catalogue, lot and serial numbers on your device against the identifiers on this page.

Can I get my money back?

Have the model, catalogue, lot and serial numbers ready before you call — they are on the device label or its box.

Where was the recalled product sold?

It was distributed nationwide.

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