Lower risk Medical device recall · FDA · Published May 21, 2019

Medtronic Hancock II T510 Bioprosthesis: Incorrect Size Labeling Risk

Medtronic recalls Hancock II T510 mitral bioprosthesis devices with mislabeled sizes that could lead to improper valve fitting during surgery.

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

🇺🇸 FDA recall #Z-1884-2019Medical device Medtr: a short, human brand name for headings (e.g. "Trsmima") ›

Lower-risk recall

Fifteen affected devices were distributed worldwide, which were mislabeled with an incorrect size. In all cases, the actual surgical heart valves are larger than what was indicated on the boxes and jar labels.

Take action

Contact the company

Recalling firmMedtronic Inc710 Medtronic Pkwy Mailstop Ls245 · Minneapolis, MN 55432-5603

✎ GovInfoNow plain-language explainer

Medtronic is recalling Hancock II T510 mitral bioprosthesis devices that were mislabeled with incorrect sizes. This could cause improper valve fitting during surgery if the wrong size is used. Read more at govinfonow.com/recall/67886-medtronic-hancock-ii-t510-bioprosthesis-incorrect-size-labeling-risk.

Source Summary by GovInfoNow · govinfonow.com/recall/67886-medtronic-hancock-ii-t510-bioprosthesis-incorrect-size-labeling-risk · Updated August 20, 2026 · FDA enforcement record: FDA #Z-1884-2019

Cite this page

“Medtronic Hancock II T510 Bioprosthesis: Incorrect Size Labeling Risk.” GovInfoNow, updated August 20, 2026. https://govinfonow.com/recall/67886-medtronic-hancock-ii-t510-bioprosthesis-incorrect-size-labeling-risk. Based on FDA recall #Z-1884-2019 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1884-2019%22&limit=1).

The FDA announced on May 21, 2019, that Medtronic Inc. is recalling Hancock II T510 Bioprosthesis, Mitral devices due to mislabeling hazards. The agency stated the recall was voluntary and initiated by the firm.

How to tell if you have it

Brand: Medtronic
Product: Hancock II T510 Bioprosthesis, Mitral
REF: T510C27
UPC: 00643169594425
Serial Number: B710405

The hazard

Fifteen affected devices distributed worldwide were mislabeled with an incorrect size. In all cases, the actual surgical heart valves are larger than what was indicated on the boxes and jar labels.

Context

GovInfoNow's records show Medtronic, Inc. has 38 other recalls on record since 2017-09-10. Recent Medtronic recalls include a Sphere-9 Catheter recall dated 2026-03-11 for risk of ventricular fibrillation and an Abre Venous Stent recall dated 2025-12-04 regarding nitinol anomaly migration risks. Other recent recalls of similar products include DT MedTech Hintermann Talar Implant Left Size 2 (2026-03-24), XTANT Medical Xpress Pedicle Screw System (2026-02-18), and Micro Therapeutics Pipeline Flex Embolization Device (2026-06-08).

How to tell if you have this one

Check for the model number T510C27 on the device packaging. The serial number B710405 is also associated with this recall.

Brand
Medtr: a short, human brand name for headings (e.g. "Trsmima")
Product
Medtronic Inc recalls Hancock II T510 Bioprosthesis, Mitral, REF T510C27
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
Terminated
Distribution
Worldwide distribution - US Nationwide distribution in the states of TN, NY, NJ, and countries of France, Italy, Libya, Poland, Spain.

Recall number	Product, codes & lots	Quantity
Z-1880-2019	Mosaic 310 Bioprosthesis, Mitral, REF 310C29 - Product Usage: Replacement of malfunctioning native or prosthetic aortic and/or mitral valves.; GTIN: 00643169594852 Serial Number: B743335	1 unit
Z-1881-2019	Mosaic 310 Bioprosthesis, Mitral, REF 310C31 - Product Usage: Replacement of malfunctioning native or prosthetic aortic and/or mitral valves.; GTIN: 00643169594869 Serial Number: B804937	1 unit
Z-1882-2019	Hancock II T510 Bioprosthesis, Mitral, REF T505U227 - Product Usage: Replacement of malfunctioning native or prosthetic aortic and/or mitral valves.; GTIN: 00643169000261 Serial Numbers: B167637, B192698, B217347, B217329, B217330	5 units
Z-1883-2019	Hancock II T510 Bioprosthesis, Mitral, REF T510C27 - Product Usage: Replacement of malfunctioning native or prosthetic aortic and/or mitral valves.; GTIN: 00643169027077 Serial Numbers: B654768, B694390, B818699, B887929, B896723, B896730, B914146	7 units
Z-1884-2019	Hancock II T510 Bioprosthesis, Mitral, REF T510C27 - Product Usage: Replacement of malfunctioning native or prosthetic aortic and/or mitral valves.; GTIN: 00643169594425 Serial Number: B710405	1 unit

Based on the official FDA remedy

What to do — step by step

Check Device Packaging
Look for the model number T510C27 and serial number B710405 on the device packaging.

Where it went and when

Where it was distributed

Distributed nationwide and abroad; the notice names 3 states.

FDA distribution: “Worldwide distribution - US Nationwide distribution in the states of TN, NY, NJ, and countries of France, Italy, Libya, Poland, Spain.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Named in the notice: New Jersey, New York, Tennessee.

Recall timeline

FDA terminated this recall 17 months after the firm started it.

May 21, 2019Firm started the recall
Jun 26, 2019FDA classified it Class II
Jul 3, 2019Published in FDA’s Enforcement Report
Oct 7, 2020FDA terminated the recall

Dates from the agency record only; steps without a date are left out.

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Link to this recall

<a href="https://govinfonow.com/recall/67886-medtronic-hancock-ii-t510-bioprosthesis-incorrect-size-labeling-risk">Medtronic Hancock II T510 Bioprosthesis: Incorrect Size Labeling Risk (GovInfoNow)</a>

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-1884-2019 (May 21, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1884-2019 to see it in context.
Plain-language summary written by qwen3:4b on August 20, 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.