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

Hancock II T510 Bioprosthesis, Mitral recalled by Medtronic

Medtronic is recalling Hancock II T510 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: 00643169594425 Serial Number: B710405

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-1884-2019
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

Hancock II T510 Bioprosthesis, Mitral, REF T510C27 - 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

Is Hancock II T510 Bioprosthesis, Mitral recalled?

Yes. Medtronic recalled Hancock II T510 Bioprosthesis, Mitral on 21 May 2019. The recall is Class II and its status is Terminated. Recall number Z-1884-2019.

Why was it recalled?

Which lots are affected?

GTIN: 00643169594425 Serial Number: B710405

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

More recalls from Medtronic

All 148

Reported	Class	Recall	Company	Reason	Where
6 May 2026Device	CLASS II	Sphere-9 Catheter recalled by Medtronic	Medtronic	Other	MN
21 Jan 2026Device	CLASS II	Abre Venous Self-Expanding Stent System recalled by Medtronic	Medtronic	Other	Nationwide
30 Jul 2025Device	CLASS II	CareLink SmartSync Device Manager recalled by Medtronic	Medtronic	Device Malfunction	Nationwide
30 Jul 2025Device	CLASS II	CareLink SmartSync Patient Connector recalled by Medtronic	Medtronic	Device Malfunction	Nationwide
23 Jul 2025Device	CLASS II	Medtronic SmartLink software loaded on CareLink SmartSync Device recalled	Medtronic	Device Malfunction	MN

Other Heart & Vascular Devices recalls

All 6,199

Reported	Class	Recall	Company	Reason	Where
16 Sep 2026Device	CLASS II	Getinge PVC Thoracic Catheter, Soft PVC Right Angle recalled	Atrium Medical	Potency & Assay	Nationwide
16 Sep 2026Device	CLASS II	Products that contain the Pericare Wipes: *Bardex¿ I.C recalled	C.R. Bard	Other	Nationwide
16 Sep 2026Device	CLASS II	Products that contain the Pericare Wipes recalled by C.R. Bard	C.R. Bard	Other	Nationwide
16 Sep 2026Device	CLASS II	Products that contain the Pericare Wipes recalled by C.R. Bard	C.R. Bard	Other	Nationwide
16 Sep 2026Device	CLASS II	Getinge PVC Thoracic Catheter, Firm PVC Straight recalled	Atrium Medical	Potency & Assay	Nationwide