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U.S. Department of Health and Human Services

Class 3 Device Recall Hancock II Bioprostheses with Cinch

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  Class 3 Device Recall Hancock II Bioprostheses with Cinch see related information
Date Initiated by Firm January 26, 2009
Date Posted May 29, 2009
Recall Status1 Terminated 3 on May 22, 2012
Recall Number Z-1226-2009
Recall Event ID 51220
PMA Number P980043 
Product Classification Replacement Heart-Valve - Product Code DYE
Product Hancock II Bioprostheses with Cinch, Heart Valve, Model # T505 & T510; Catalog #s T505C2501, T505C2101, T505U25ID , T505C2301, T505C2301, T505C2501, T505C2101, T510C29ID, T510C25ID, and T510C27ID;
Sterile LC; Rx only; Medtronic Inc 710 Medtronic Parkway, Minneapolis, MN 55432-5604, Manufactured at: Santa Ana, Ca.

Indicated for the replacement of malfunctioning native or aortic and mitral heart valves.
Code Information Lot Serial #  25A07L4976, 21A08D0985, 25A06H1684, 23A07T1262, 23A08B5266, 25A08F0564, 21A07R2878, 29M07V3883, 25M07T4827, and  27M07V0682. 
Recalling Firm/
Manufacturer		 Medtronic Inc
710 Medtronic Pkwy
Minneapolis MN 55432-5603
For Additional Information Contact
763-505-2562
Manufacturer Reason
for Recall		 Medtronic identified several heart valves (Mosaic Porcine Bioprosthesis with Cinch & Hancock II Bioprosthesis with Cinch) that were inadvertently distributed after exposure to temperatures exceeding the 77 F (25 C) maximum storage temperature published on the labeling. The product is being retrieved as they do not meet the handling requirements.
FDA Determined
Cause 2		 Storage
Action A Medtronic "Urgent Medical Device Recall Notice" dated January 26, 2009, was sent to Risk Managers of each affected account and to each Implanting Physician. The letter described the problem, product and informed consignees that they will be retrieving the non-implanted vales. If additional information is needed, customers are to contact their local Medtronic sales representative or technical services at 1-877-526-7890.
Quantity in Commerce 10
Distribution Nationwide Distribution -- Including states of CT, FL, MD, MA, MI, NC, OH, OR, PA, SD, TN, TX, WI, and WA.
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.
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