Events

Recall of Device Recall Hancock II Bioprostheses with Cinch

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Medtronic Inc.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    51220
  • Event Risk Class
    Class 3
  • Event Number
    Z-1226-2009
  • Event Initiated Date
    2009-01-26
  • Event Date Posted
    2009-05-29
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-05-22
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=79252
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Replacement Heart-Valve - Product Code DYE
  • Reason
    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.
  • 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.

Device

Device Recall Hancock II Bioprostheses with Cinch
  • Model / Serial
    Lot Serial #  25A07L4976, 21A08D0985, 25A06H1684, 23A07T1262, 23A08B5266, 25A08F0564, 21A07R2878, 29M07V3883, 25M07T4827, and  27M07V0682.
  • Product Classification
    Cardiovascular Devices
  • Device Class
    3
  • Implanted device?
    Yes
  • Distribution
    Nationwide Distribution -- Including states of CT, FL, MD, MA, MI, NC, OH, OR, PA, SD, TN, TX, WI, and WA.
  • Product Description
    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.
  • Manufacturer
    Medtronic Inc

Manufacturer

Medtronic Inc
  • Manufacturer Address
    Medtronic Inc, 710 Medtronic Pkwy, Minneapolis MN 55432-5603
  • Manufacturer Parent Company (2017)
    Medtronic plc
  • Manufacturer comment
    “If our surveillance systems identify a potential performance issue, our personnel promptly evaluate the problem, including, when appropriate, conducting root cause investigations and internal testing to assess whether the product continues to meet specifications and defined performance criteria,” Medtronic told ICIJ in a statement. “In some cases, based on this evaluation, Medtronic may determine that a recall is necessary.” The company said that it communicates with healthcare providers and/or patients and provide recommendations to address such issues. Medtronic noted that these communications can include letters, emails, calls, press releases, physician notifications and social media postings, as well as informing the FDA and other regulators of the actions.
  • Source
    USFDA