Events

Recall of Device Recall PINNACLE Introducer Sheath

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

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
    73833
  • Event Risk Class
    Class 2
  • Event Number
    Z-2738-2016
  • Event Initiated Date
    2016-03-16
  • Event Date Posted
    2016-09-06
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-01-27
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=145071
  • 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
    Terumo medical is initiating this recall due to complaints of valve leakage that have been related to a manufacturing issue. if affected introducer sheaths are used, there is possible risk of incremental blood loss through the valve.
  • Action
    Terumo sent an Urgent Product Recall Bulletin dated March 7, 2016, to all affected customers. All affected customers will be notified regarding the required recall actions (stop using/quarantine the affected products). TMC will strive for 100% verification to confirm that all customers have acknowledged the recall. Follow-up communication is being sent specifying the mechanisms to be used for labeling and returning the involved product from the customer level. We regret any inconvenience this action may cause your operations and we appreciate your understanding. Please contact us if you need assistance procuring additional inventory. We are committed to continuing to offer products that meet the highest quality standards that you expect from Terumo Medical Corporation. If you have questions or need further information, please call Customer Care at 1-800-888-3786 or contact your local sales representative. For further questions regarding this recall please call (410) 392-7226.

Device

Device Recall PINNACLE Introducer Sheath
  • Model / Serial
    Please see Attachment 3
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution
  • Product Description
    PINNACLE¿ Introducer Sheath || PINNACLE PRECISION ACCESS SYSTEM¿ Sheath || PINNACLE¿ TIF TIP" Introducer Sheath || PINNACLE¿ R/O II Radiopaque Marker Introducer Sheath
  • Manufacturer
    Terumo Medical Corporation

Manufacturer

Terumo Medical Corporation
  • Manufacturer Address
    Terumo Medical Corporation, 950 Elkton Blvd, Elkton MD 21921-5322
  • Manufacturer Parent Company (2017)
    Terumo Corp.
  • Source
    USFDA