Events

Recall of Boston Scientific, Z Flex 270, Steerable Sheath

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
    63141
  • Event Risk Class
    Class 2
  • Event Number
    Z-2459-2012
  • Event Initiated Date
    2012-09-06
  • Event Date Posted
    2012-09-26
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2015-01-22
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=112674
  • 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
    Catheter, steerable - Product Code DRA
  • Reason
    During the investigation of four returned z flex 270 steerable sheaths that were used with cardiac cryoablation balloon catheters, the internal ptfe sheath liners were found to display varying degrees of damage that could pose an embolic risk to a patient.
  • Action
    Greatbatch Medical sent a "SAFETY ALERT-Z-FLEX-270 STEERABLE SHEATH" letter dated September 6, 2012 to the affected customer. The letter identified the product, problem, and actions to be taken by the customer. The letter advised the customer to communicate with their customers to assure the that the recalled sheath model is not used in conjunction with cryoablation catheters. Contact the firm at 763-951-8214 for questions regarding this issue.

Device

Boston Scientific, Z Flex 270, Steerable Sheath
  • Model / Serial
    Q2112752, Q2110939, Q2130137, Q2131250, Q2130212, Q2150143, W2162515, W2163769, W2160626, W2175891, W2172722, W2184492, W2196366, W2184490, W2205843
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Distributed in MA.
  • Product Description
    Boston Scientific, Z Flex 270, Steerable Sheath, Sterile EO, Rx only, Distributed by Boston Scientific Corporation, One Boston Scientific Place, Natick, MA 01760-1537, Manufactured by Greathbatch Medical, 2300 Berkshire Lane North, Minneapolis, MN 55441. || To facilitate transvenous introduction of diagnostic / therapeutic catheters into the vasculature and into the chambers of the heart.
  • Manufacturer
    Greatbatch Medical

Manufacturer

Greatbatch Medical
  • Manufacturer Address
    Greatbatch Medical, 2300 Berkshire Ln N, Minneapolis MN 55441-4575
  • Manufacturer Parent Company (2017)
    Integer Holdings Corporation
  • Source
    USFDA