Events

Recall of Device Recall Permanent Pacing Lead

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
    48678
  • Event Risk Class
    Class 2
  • Event Number
    Z-2333-2008
  • Event Initiated Date
    2008-01-29
  • Event Date Posted
    2008-09-24
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2008-11-14
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=71853
  • 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
    Permanent Pacemaker Electrode - Product Code DTB
  • Reason
    The o-rings are over tolerance making it hard to connect the leads to the pacemaker.
  • Action
    On January 24, 08, Oscor sent out a letter to doctors/ customers with the subject line of "Re: Market Withdrawal of Permanent Pacing Leads due to the lead connector insertion difficulty," stating they experienced some difficulties with the insertion of pacing lead connectors into the pacemaker headers. They asked that customers review the inventory list and remove all products, whose serial numbers match the serial numbers on the list and have not been implanted. Also, customers should call Oscor customer service for a Return Goods Product number and return the product back to the firm for replacement.

Device

Device Recall Permanent Pacing Lead
  • Model / Serial
    02-01502, 02-01812, 02-01436, 02-01440, 02-02016, and 02-01945
  • Product Classification
    Cardiovascular Devices
  • Device Class
    3
  • Implanted device?
    Yes
  • Distribution
    Nationwide Distribution
  • Product Description
    Permanent Pacing Lead (Catalog #: 03332, 03334, 03337, 03107, 03116, 03108, 03109, 05756, 53420, 05765, 03634, 03633, and 05747); Model #: PY244RU, PY252RU, PY258RU, REFINO58RU, REFINO 52RJU, REFINO 44RJU, REFINO48RJU, BIS/IS-15, BIS/BIS-17, VKU-10V, MP52PV, MP40PV, C/IS-10; Manufactured by Oscor. || Pacing and sensing of the ventricle and/or atrium of the heart in conjunction with a compatible, implantable pulse generator/pacemaker.
  • Manufacturer
    Oscor, Inc.

Manufacturer

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