Events

Recall of Device Recall Stretta

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Curon Medical 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
    25680
  • Event Risk Class
    Class 2
  • Event Number
    Z-0663-03
  • Event Initiated Date
    2003-02-21
  • Event Date Posted
    2003-03-20
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2003-04-21
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=26255
  • 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, Intravascular, Diagnostic - Product Code DQO
  • Reason
    Catheter shaft has potential to crack during use.
  • Action
    On 2/21/03 the firm initiated the recall and its notification was via letters to inform its consignees about the problem with its catheters. It requests immediate discontinuance of all product with certain lot numbers.

Device

Device Recall Stretta
  • Model / Serial
    FD1268 thru FD1282
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Product was released for distribution to 52 direct accounts nationwide including 1 VA Medical Center, Endoscopy Dept., 150 S. Huntington Ave., Boston, MA 02130, ATTN: Dr. Hiroshi Mashimo, ph#: 617-363-5640.
  • Product Description
    Stretta brand Catheter and Accessory Kit, Part # 175-2575. Model 4301K
  • Manufacturer
    Curon Medical Inc

Manufacturer

Curon Medical Inc
  • Manufacturer Address
    Curon Medical Inc, 735 Palomar Avenue, Sunnyvale CA 94086
  • Source
    USFDA