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Lower risk Medical device recall · FDA · Published October 17, 2024

Abbott Navitor Heart Valve Recall: Potential Long-Term Durability Issues

Abbott Medical recalls 27mm Navitor Transcatheter Aortic Heart Valves with possible durability concerns. Affected units have specific serial numbers and UDI-DI codes. Contact Abbott for details.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-0495-2025Medical deviceAbbott Medical ›
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Contact the company

Recalling firmAbbott Medical177 E County Road B · Saint Paul, MN 55117
✎ GovInfoNow plain-language explainer

Abbott Medical is recalling certain 27mm Navitor Transcatheter Aortic Heart Valves due to potential long-term durability issues. This could lead to valve failure or reduced effectiveness over time. Read more at govinfonow.com/recall/53683-abbott-navitor-heart-valve-recall-potential-long-term-durability-issues.

Source Summary by GovInfoNow · govinfonow.com/recall/53683-abbott-navitor-heart-valve-recall-potential-long-term-durability-issues · Updated August 18, 2026 · FDA enforcement record: FDA #Z-0495-2025

Cite this page

“Abbott Navitor Heart Valve Recall: Potential Long-Term Durability Issues.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/53683-abbott-navitor-heart-valve-recall-potential-long-term-durability-issues. Based on FDA recall #Z-0495-2025 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0495-2025%22&limit=1).

The FDA announced on Oct. 17, 2024, that Abbott Medical is recalling its Navitor Transcatheter Aortic Heart Valve, 27 mm (NVTR-27), Sterile due to a manufacturing error affecting leaflet deflection values. This defect could impact the valve's long-term durability or cause potential failure.

How to tell if you have it

  • Brand: Abbott Medical
  • Product: Abbott Navitor Transcatheter Aortic Heart Valve, 27 mm, NVTR-27, Sterile
  • UDI-DI (GTIN): 5415067031594
  • Serial Numbers: 20110016, 20155472, 20155476, 20166304, & 20168050
  • Quantity: 5 OUS

The hazard

According to the FDA, a manufacturing error resulted in the acceptance of valves with leaflet deflection values outside established specifications. This could potentially affect the long-term durability of the impacted valve and/or cause potential valve failure.

Context

GovInfoNow's records show Abbott Medical has 15 other recalls on record since Oct. 14, 2019. Recent brand recalls include a May 12, 2026, software malfunction risk for the Merlin PCS 365 and an Oct. 6, 2025, communication loss issue with the Liberta RC DBS IPG Model 62400. Other recent recalls of similar products include a Feb. 1, 2026, unconfirmed release specifications issue for the On-X Mitral Heart Valve and a June 11, 2026, air embolism risk from valve damage in the Boston Scientific FARADRIVE Steerable Sheath.

How to tell if you have this one

Check the serial numbers: 20110016, 20155472, 20155476, 20166304, or 20168050. Also verify the UDI-DI code (GTIN): 5415067031594.

  • Brand
    Abbott Medical
  • Category
    Medical device
FDA recall event · 5 products

All 5 products in this recall

FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.

  • Classification
    Class II
  • Status
    Ongoing
  • Distribution
    New York, Australia, Belgium, Germany, Iran, Israel, Japan, Kazakhstan, Oman, Poland, Romania, Slovakia, Spain, Turkey, United Kingdom.
Recall numberProduct, codes & lotsQuantity
Z-0491-2025Abbott Navitor Titan, Vision Technology, Transcatheter Aortic Heart Valve, 35 mm, NVRO-35, Sterile; UDI-DI (GTIN): 05415067045768, Serial Numbers: 20078589, 20357219, 20357226, 20357685, 20358319, 20358343, 20358351, 20358363, 20358368, & 20358370.1 US, 9 OUS
Z-0492-2025Abbott Navitor Transcatheter Aortic Heart Valve, 29 mm, NVTR-29, Sterile; UDI-DI (GTIN): 5415067031600, Serial Number: 201314781 OUS
Z-0493-2025Abbot Navitor, Vision Technology, Transcatheter Aortic Heart Valve, 29 mm, NVRO-29, Sterile; UDI-DI (GTIN): 5415067045775, Serial Numbers: 20150441, 20156804, & 201705353 OUS
Z-0494-2025Abbott Navitor, Vision Technology, Transcatheter Aortic Heart Valve, 27 mm, NVRO-27, Sterile; UDI-DI (GTIN): 5415067045799, Serial Numbers: 20158135, 20172203, 20183968, 20184552, 20184670, 20184675, 20190249, & 20213055.8 OUS
Z-0495-2025Abbott Navitor Transcatheter Aortic Heart Valve, 27 mm, NVTR-27, Sterile; UDI-DI (GTIN): 5415067031594, Serial Numbers: 20110016, 20155472, 20155476, 20166304, & 20168050.5 OUS
Based on the official FDA remedy

What to do — step by step

  1. Check Serial Numbers

    Look for the serial numbers listed: 20110016, 20155472, 20155476, 20166304, or 20168050.

Where it went and when

Where it was distributed

Distributed in New York, and outside the U.S.

Alaska: not listedAKMaine: not listedMEVermont: not listedVTNew Hampshire: not listedNHWashington: not listedWAIdaho: not listedIDMontana: not listedMTNorth Dakota: not listedNDMinnesota: not listedMNIllinois: not listedILWisconsin: not listedWIMichigan: not listedMINew York: yesNYRhode Island: not listedRIMassachusetts: not listedMAOregon: not listedORNevada: not listedNVWyoming: not listedWYSouth Dakota: not listedSDIowa: not listedIAIndiana: not listedINOhio: not listedOHPennsylvania: not listedPANew Jersey: not listedNJConnecticut: not listedCTCalifornia: not listedCAUtah: not listedUTColorado: not listedCONebraska: not listedNEMissouri: not listedMOKentucky: not listedKYWest Virginia: not listedWVVirginia: not listedVAMaryland: not listedMDDelaware: not listedDEArizona: not listedAZNew Mexico: not listedNMKansas: not listedKSArkansas: not listedARTennessee: not listedTNNorth Carolina: not listedNCSouth Carolina: not listedSCDistrict of Columbia: not listedDCOklahoma: not listedOKLouisiana: not listedLAMississippi: not listedMSAlabama: not listedALGeorgia: not listedGAHawaii: not listedHITexas: not listedTXFlorida: not listedFL

FDA distribution: “New York, Australia, Belgium, Germany, Iran, Israel, Japan, Kazakhstan, Oman, Poland, Romania, Slovakia, Spain, Turkey, United Kingdom.” States read from FDA’s own wording; “not listed” means the notice does not name it.

States: New York.

Recall timeline

FDA published this recall 41 days after the firm started it.

1. Firm started the recall: Oct 17, 202412. FDA classified it Class II: Nov 20, 202423. Published in FDA’s Enforcement Report: Nov 27, 202432024
  1. Firm started the recall
  2. FDA classified it Class II
  3. 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-0495-2025 (October 17, 2024) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0495-2025 to see it in context.
  • Plain-language summary written by qwen3:4b on August 18, 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.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA