Medtronic recalls specific Abre Venous Self-expanding Stent Systems due to potential sterile package breach. Affected product numbers include AB9U14080090, AB9U18100090, and AB9G14100090. No remedy is specified in the recall notice.
There is a potential for sterile package breach.
Medtronic is recalling three specific models of Abre Venous Self-expanding Stent Systems because there's a potential for the sterile packaging to breach. This could lead to contamination of the device, but the recall does not include a remedy or action for consumers.
The sterile packaging could breach, potentially contaminating the stent with bacteria or other harmful substances. This contamination could lead to infections or other complications during or after the procedure.
Patients who have received one of the recalled stent models during surgery are likely affected. Medical professionals using these stents for procedures are at risk if the packaging breaches.
Check the product number on the stent package: AB9U14080090, AB9U18100090, or AB9G14100090. Also look for the batch number (B456626, B456811, or B460542) to confirm if it's affected.
Identify the product number on the stent package to see if it matches the recalled models: AB9U14080090, AB9U18100090, or AB9G14100090.
The recall notice does not specify any remedy or action for consumers.
The recall states there is a potential for sterile package breach, which could lead to contamination and infection risks during or after the procedure.
Check the product number on the stent package: AB9U14080090, AB9U18100090, or AB9G14100090. Also look for the batch number (B456626, B456811, or B460542).
We’ve drafted a message you can send Medtronic to request your refund or repair — edit it as you like.
Subject: Recall Z-1317-2024 — Medtronic Medtronic Hello, I own a Medtronic that is covered by recall Z-1317-2024 from Medtronic. 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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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.