Hancock II T510 Bioprosthesis, Mitral, REF T510C27 -… recallZ-1883-2019 · Medtronic Inc · initiated May 21, 2019
Terminated
Is my device affected?
- 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.
- 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.
- 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-1883-2019
- Status
- Terminated
- Initiated by the company
- May 21, 2019
- Posted by the FDA
- Jun 26, 2019
- Recalling firm
- Medtronic Inc
- Quantity
- 7 units
- Product code
- DYE
- FDA submissions
- P980043
- Distribution
- Worldwide distribution - US Nationwide distribution in the states of TN, NY, NJ, and countries of France, Italy, Libya, Poland, Spain.
Product description
Hancock II T510 Bioprosthesis, Mitral, REF T510C27 - Product Usage: Replacement of malfunctioning native or prosthetic aortic and/or mitral valves.
Code information (models, lots, serial numbers)
GTIN: 00643169027077 Serial Numbers: B654768, B694390, B818699, B887929, B896723, B896730, B914146
Other devices under the same FDA submission
62 devices cleared under P980043 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- HANCOCK® II T510C31Medtronic, Inc. · replacement Heart-valve1 recall1 death12 reports
- HANCOCK® II T505C221Medtronic, Inc. · heart-valve, non-allograft tissue27 reports
- HANCOCK® II T505C223Medtronic, Inc. · heart-valve, non-allograft tissue27 reports
- HANCOCK® II T505U223Medtronic, Inc. · heart-valve, non-allograft tissue4 deaths20 reports
- HANCOCK® II T505C225Medtronic, Inc. · heart-valve, non-allograft tissue18 reports
- HANCOCK® II T505C223Medtronic, Inc. · replacement Heart-valve1 death15 reports
- HANCOCK® II T505C225Medtronic, Inc. · replacement Heart-valve2 deaths15 reports
- HANCOCK® II T505C227Medtronic, Inc. · heart-valve, non-allograft tissue14 reports
- HANCOCK® II T510C27Medtronic, Inc. · replacement Heart-valve1 death14 reports
- HANCOCK® II T510C31Medtronic, Inc. · heart-valve, non-allograft tissue1 death13 reports
- HANCOCK II ULTRA® T505U225Medtronic, Inc. · heart-valve, non-allograft tissue12 reports
- HANCOCK II ULTRA® T505U223Medtronic, Inc. · replacement Heart-valve1 death12 reports
Other products in the same recall event
The FDA groups related products into one recall event (event 83038).
- Z-1880-2019 · TerminatedMosaic 310 Bioprosthesis, Mitral, REF 310C29 - Product Usage: Replacement of malfunctioning native or prosthetic aortic and/or mitral valves.
- Z-1881-2019 · TerminatedMosaic 310 Bioprosthesis, Mitral, REF 310C31 - Product Usage: Replacement of malfunctioning native or prosthetic aortic and/or mitral valves.
- Z-1882-2019 · TerminatedHancock II T510 Bioprosthesis, Mitral, REF T505U227 - Product Usage: Replacement of malfunctioning native or prosthetic aortic and/or mitral valves.
- Z-1884-2019 · TerminatedHancock II T510 Bioprosthesis, Mitral, REF T510C27 - Product Usage: Replacement of malfunctioning native or prosthetic aortic and/or mitral valves.
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
How recalls are matched to devices · Editorial policy · Report an error on this page