Skip to content

MOSAIC recallZ-1880-2019 · Medtronic Inc · initiated May 21, 2019

Terminated

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Medtronic Inc or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

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.

FDA root cause category: Labeling mix-ups

What the company is doing

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.

Recall details

Recall number
Z-1880-2019
Status
Terminated
Initiated by the company
May 21, 2019
Posted by the FDA
Jun 26, 2019
Recalling firm
Medtronic Inc
Quantity
1 unit
Product code
DYE
FDA submissions
P990064
Distribution
Worldwide distribution - US Nationwide distribution in the states of TN, NY, NJ, and countries of France, Italy, Libya, Poland, Spain.

Product description

Mosaic 310 Bioprosthesis, Mitral, REF 310C29 - Product Usage: Replacement of malfunctioning native or prosthetic aortic and/or mitral valves.

Code information (models, lots, serial numbers)

GTIN: 00643169594852 Serial Number: B743335

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Product lines

Other devices under the same FDA submission

100 devices cleared under P990064 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.

Other products in the same recall event

The FDA groups related products into one recall event (event 83038).

Sources and updates

How recalls are matched to devices · Editorial policy · Report an error on this page