CLASS II Device recall · Reported 3 Jul 2019 · FDA Enforcement Report

Mosaic 310 Bioprosthesis, Mitral recalled by Medtronic

Medtronic is recalling Mosaic 310 Bioprosthesis, Mitral, distributed nationwide in the US. The recall was initiated on 21 May 2019 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesGTIN: 00643169594869 Serial Number: B804937

Quantity recalled1 unit

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1881-2019
FDA event ID: 83038
Recalling firm: Medtronic, Minneapolis, MN
Classification: Class II
Status: Terminated
Recall initiated: 21 May 2019
FDA classified: 26 Jun 2019
Reported: 3 Jul 2019
Type: Voluntary: Firm initiated
Customers notified by: Telephone
Reason category: Labeling Errors
Device type: Heart & Vascular Devices

Timeline

21 May 2019	Recall initiated by company
26 Jun 2019	Classified by FDA	+36 days
3 Jul 2019	Published in enforcement report	+7 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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.

Product as listed by the FDA

Mosaic 310 Bioprosthesis, Mitral, REF 310C31 - Product Usage: Replacement of malfunctioning native or prosthetic aortic and/or mitral valves.

Where it was distributed

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

Nationwide New Jersey New York Tennessee

Questions about this recall

Why was it recalled?

Which lots are affected?

GTIN: 00643169594869 Serial Number: B804937

Where was it sold?

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

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

4 other products · FDA event 83038

This product is part of a recall event; the main page for the event is Hancock II T510 Bioprosthesis, Mitral recalled by Medtronic.

Reported	Class	Recall	Company	Reason	Where
3 Jul 2019	CLASS II	Hancock II T510 Bioprosthesis, Mitral recalled by Medtronic	Medtronic	Labeling Errors	Nationwide
3 Jul 2019	CLASS II	Mosaic 310 Bioprosthesis, Mitral recalled by Medtronic	Medtronic	Labeling Errors	Nationwide
3 Jul 2019	CLASS II	Hancock II T510 Bioprosthesis, Mitral recalled by Medtronic	Medtronic	Labeling Errors	Nationwide
3 Jul 2019	CLASS II	Hancock II T510 Bioprosthesis, Mitral recalled by Medtronic	Medtronic	Labeling Errors	Nationwide

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