Events

Recall of Device Recall Scimed ChoIce Floppy PTCA Guide Wire 182 cm

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

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
    25512
  • Event Risk Class
    Class 3
  • Event Number
    Z-0592-03
  • Event Initiated Date
    2002-11-19
  • Event Date Posted
    2003-02-27
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2008-04-15
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=25947
  • 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
    Wire, Guide, Catheter - Product Code DQX
  • Reason
    Product is mislabled as a choice floppy guide wire when it is actually a choice es(extra support) guide wire.
  • Action
    Recall Letters issued 11/19/2002 via Federal Express to 7 hospital accounts. Consignees were requested to fill out a response form and return product to their Quincy, MA facility.

Device

Device Recall Scimed ChoIce Floppy PTCA Guide Wire 182 cm
  • Model / Serial
    Individual pouch codes are coded catalog # 12132-01, batch 4785750 expiration date 2004-05 and the five pack outer boxes are coded: Catalog No. 12132-01, batch 4806821 expiration date 2004-5.
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Product was distributed to hospitals in FL, MI, GA, OR, ID AND CT. 05.
  • Product Description
    Product is a ChoICE 182 cm Guide Wire, intended to facilitate placement of balloon dilatation catheters and other therapeutic devices during Percutaneous Transluminal Coronary Angioplasty (PTCA) procedures. The ChoICE guide wire contains a one-piece stainless steel core, which extends throughout the length of the wire and provides steerability and torqueability. The wire is tapered and formed at the distal tip. A radiopaque platinum spring coil surrounds the distal tip of the core wire. || The ChoICE Guide Wire is a single use, sterile (EO), device packaged in a carrier tube, which is held in a coil by plastic clips. The carrier tube assembly of the guide wire is sealed into a pouch. One side of the pouch is clear polyethylene/polyester laminate and the reverse side is Tyvek. The pouch assemblies are packaged in a five-pack product box. A flushing tool is included in the package to facilitate hydration of the coating with heparanized saline before use. || 1, page 1, is a copy of the pouch label. Exhibit 1, page 2 is a copy of the five-pack product box label. Exhibit 2 is a copy of the Directions for Use.
  • Manufacturer
    Symbiosis Corp.

Manufacturer

Symbiosis Corp.
  • Manufacturer Address
    Symbiosis Corp., 8600 NW 41th Street, Miami FL 33166
  • Source
    USFDA