Events

Recall of Device Recall Myocardial Heart Wires

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Oscor, 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
    63112
  • Event Risk Class
    Class 2
  • Event Number
    Z-0165-2013
  • Event Initiated Date
    2012-07-25
  • Event Date Posted
    2012-10-29
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2013-12-17
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=112581
  • 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
    Electrode, pacemaker, temporary - Product Code LDF
  • Reason
    Oscor, inc. in palm harbor, fl is recalling myocardial heart wires, models tme60s, tme64s, tme64c, tme64s-3, tme65s, and tme66s. the recall was initiated due to the spacing between anchoring zig-zag to electrode is out of specification.
  • Action
    Oscor sent a customer notification letter dated July 25, 2012, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to send the listed models and lots in their inventory back to the recalling firm for immediate replacement. They were also instructed to call Oscor Customer Service at 727-937-2511 to obtain a Return Goods Product (RGA) number. For questions regarding this recall call 727-937-2511, ext. 133.

Device

Device Recall Myocardial Heart Wires
  • Model / Serial
    Model Number TME60S, Lot #C1-07101 Model Number TME64S, Lot #C1-07056 Model Number TME64S, Lot #C1-07057 Model Number TME64S, Lot #C1-07058 Model Number TME64S, Lot #C1-07111 Model Number TME64S, Lot #C1-07112 Model Number TME64S, Lot #C1-07113 Model Number TME64S, Lot #C1-07114 Model Number TME64S, Lot #C1-07122 Model Number TME64S, Lot #C1-07123 Model Number TME64S, Lot #C1-07124 Model Number TME64S, Lot #C1-07125 Model Number TME64C, Lot #C1-07143 Model Number TME64S, Lot #C1-07151 Model Number TME64S-3, Lot #C1-07156 Model Number TME65S, Lot #C1-07174
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA including OR, FL, Al, TX, NM, CA, AL, PA, KY, IN, OH, and IL and internationally to Canada, Russia, and New Zealand
  • Product Description
    Myocardial Heart Wires || Intended for temporary atrial and ventricular pacing and sensing during or after cardiac surgery in conjunction with an external pulse generator.
  • Manufacturer
    Oscor, Inc.

Manufacturer

Oscor, Inc.
  • Manufacturer Address
    Oscor, Inc., 3816 Desoto Boulevard, Palm Harbor FL 34683-1618
  • Manufacturer Parent Company (2017)
    Oscor Inc.
  • Source
    USFDA