—#173390

Product

Hancock II T510 Bioprosthesis, Mitral, REF T505U227 - Product Usage: Replacement of malfunctioning native or prosthetic aortic and/or mitral valves.

FDA product code: DYE — Replacement Heart-Valve
Device class: Class 3
Medical specialty: Cardiovascular
PMA numbers: P980043
Affected lot / code info: GTIN: 00643169000261 Serial Numbers: B167637, B192698, B217347, B217329, B217330

Why it was recalled

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 (FDA determination)

Labeling mix-ups

Action the firm took

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.

Recalling firm

Firm: Medtronic Inc
Address: 710 Medtronic Pkwy, Mailstop Ls245, Minneapolis, Minnesota 55432-5603

Distribution

Distribution pattern: Worldwide distribution - US Nationwide distribution in the states of TN, NY, NJ, and countries of France, Italy, Libya, Poland, Spain.

Timeline

Recall initiated: 2019-05-21
Posted by FDA: 2019-06-26
Terminated: 2020-10-07
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #173390. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.