Events

Recall of Device Recall OptiSeal Valved PTFE Peelable Introducer

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

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
    56281
  • Event Risk Class
    Class 2
  • Event Number
    Z-2294-2010
  • Event Initiated Date
    2010-07-02
  • Event Date Posted
    2010-08-27
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-12-17
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=93135
  • 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
    Introducer, catheter - Product Code DYB
  • Reason
    The outer sterile barrier (pouch) packaging for the 12 fr device is not intact. no breaches in the inner sterile barrier (tray/tyvek lid) have been identified. the optiseal introducer and accessories sealed in the tray are sterile. infection may result if a sterile field is contaminated by the outer surface of the inner tray.
  • Action
    Greatbatch Medical issued an "Urgent Medical Device Recall letter dated July 12, 2010 via email to consignees. The letter described the problem and affected device. Consignees were instructed to immediately discontinue distribution of the product and return the unused units to Greatbatch Medical and to notify their customers to immediately return unused units. For shipping assistance, questions or assistance in notifying accounts, contact Shannon Springer at 763 951-8244 or Kimberly Briggs, 716 759-5702.

Device

Device Recall OptiSeal Valved PTFE Peelable Introducer
  • Model / Serial
    Model / lot number: 1000093-001 / W1515452; 1000093-002 / W1545383; 1000093-003 / W1519579, W1524143, W1515454; 1000093-004 / W1524146, W1519578, W1520649, W1515441; 1000093-005 / W1515455; 1000093-006 / W1515456; 1000093-007 / W1560536.
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution: United States, including the states of MN and CA.
  • Product Description
    Greatbatch OptiSeal Valved PTFE Peelable Introducer, Model 1000093-001, 1000093-002, 1000093-003, 1000093-004, 1000093-005, 1000093-006, 1000093-007. Sterilized using Ethylene Oxide. Greatbatch Medical, 2300 Berkshire Lane North, Minneapolis, MN 55441 USA. The OptiSeal Valved PTFE Peelable Introducer is designed to reduce blood loss and air intake by providing hemostatic sealing at venous pressures. The device is offered in two configurations, one without a sideport and one with a sideport attached to a segment of extension tubing terminating in a 3-way stopcock.
  • Manufacturer
    Greatbatch Medical

Manufacturer

Greatbatch Medical
  • Manufacturer Address
    Greatbatch Medical, 2300 Berkshire Lane North, Minneapolis MN 55441
  • Manufacturer Parent Company (2017)
    Integer Holdings Corporation
  • Source
    USFDA