Z-1884-2019Class II

Hancock II T510 Bioprosthesis, Mitral, REF T510C27 -

Name: Z-1884-2019 Hancock II T510 Bioprosthesis, Mitral, REF T510C27 -
Creator: Medtronic Inc
Published: 2019-05-21
License: https://open.fda.gov/license/

Medtronic, Inc. / initiated 2019-05-21 / Terminated / root cause: labeling and UDI

FDA source

Medtronic Inc began a recall of Hancock II T510 Bioprosthesis, Mitral, REF T510C27 - Product Usage: Replacement of malfunctioning native or prosthetic aortic and/or mitral valves on 2019-05-21. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1884-2019
Classification: Class II
Status: Terminated
Initiated: 2019-05-21
Posted: 2019-06-26
Terminated: 2020-10-07
Recalling firm: Medtronic, Inc.
Product: Hancock II T510 Bioprosthesis, Mitral, REF T510C27 - Product Usage: Replacement of malfunctioning native or prosthetic aortic and/or mitral valves.
Product code: DYE Replacement Heart-Valve
Reason for 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.
Root cause tag: labeling and UDI
FDA root cause: Labeling mix-ups
Action: The firm initiated the recall by telephone on 05/21/2019 and followed with a letter disseminated on 06/05/2019 which requested that the consignee quarantine any unused affected product and return it to Medtronic.
Quantity in commerce: 1 unit
Distribution: Worldwide distribution - US Nationwide distribution in the states of TN, NY, NJ, and countries of France, Italy, Libya, Poland, Spain.
Product codes and lots: GTIN: 00643169594425 Serial Number: B710405

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1884-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1880-2019	Class II	Terminated	Voluntary: Firm initiated	2019-07-03	2019-06-26
Z-1881-2019	Class II	Terminated	Voluntary: Firm initiated	2019-07-03	2019-06-26
Z-1882-2019	Class II	Terminated	Voluntary: Firm initiated	2019-07-03	2019-06-26
Z-1883-2019	Class II	Terminated	Voluntary: Firm initiated	2019-07-03	2019-06-26
Z-1884-2019	Class II	Terminated	Voluntary: Firm initiated	2019-07-03	2019-06-26

Product code DYE

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)