Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall Hancock II T510 Bioprosthesis

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
  Class 2 Device Recall Hancock II T510 Bioprosthesis see related information
Date Initiated by Firm May 21, 2019
Date Posted June 26, 2019
Recall Status1 Terminated 3 on October 07, 2020
Recall Number Z-1883-2019
Recall Event ID 83038
PMA Number P980043 
Product Classification replacement Heart-valve - Product Code DYE
Product Hancock II T510 Bioprosthesis, Mitral, REF T510C27 - Product Usage: Replacement of malfunctioning native or prosthetic aortic and/or mitral valves.
Code Information GTIN: 00643169027077 Serial Numbers: B654768, B694390, B818699, B887929, B896723, B896730, B914146 
Recalling Firm/
Manufacturer		 Medtronic Inc
710 Medtronic Pkwy Mailstop Ls245
Minneapolis MN 55432-5603
For Additional Information Contact Joey Lomicky
763-526-2494
Manufacturer 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.
FDA Determined
Cause 2		 Labeling mix-ups
Action 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.
Quantity in Commerce 7 units
Distribution Worldwide distribution - US Nationwide distribution in the states of TN, NY, NJ, and countries of France, Italy, Libya, Poland, Spain.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
PMA Database PMAs with Product Code = DYE and Original Applicant = Medtronic, Inc.
-
-