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Class I Medical Device Recall: iCAD (formerly Xoft Inc.), Axxent & #xae; FlexiShield Mini, Model F5300

Wed, 04/13/2011 - 12:41pm

Recall Class:  Class I

Date Recall Initiated:  Feb. 3, 2011

Product: Axxent® FlexiShield Mini, Model F5300. 

Model Number Lot Numbers
F5300 800218, 800239, 800240, 800321, 800334, and 800335

This product was manufactured from Sept. 11, 2009 through June 28, 2010, and distributed nationwide from Oct. 2009 through Dec. 2010.

Use: The Xoft Axxent Flexishield Mini device consists of a circular silicone rubber pad containing tungsten particulate. The pad is 12.7 cm in diameter and 0.1 cm (1 mm) thick.

It is designed to:

  • Shape a therapeutic radiation therapy beam from a low energy source to provide a means to accommodate different shapes of treatment fields
  • Limit the amount of radiation encountered by the skin or healthy tissue by shielding areas that do not need radiation therapy.

The pad should be placed over the surface that needs shielding from the radiation therapy. It can be cut to accommodate the shape of the radiation therapy beam. It can be used on the skin, and it can be used to shield internal tissue from radiation therapy during Intraoperative Radiation Therapy (IORT).

Recalling Firm:

iCAD (formerly Xoft Inc.)

345 Potrero Avenue

Sunnyvale, Calif. 94085

Reason for Recall:

Xoft Axxent Flexishield Mini product may shed particles of tungsten.  After use for IORT in breast tissue, these particles can be mistaken for suspicious calcifications during follow up X-rays or scans.

Xoft conducted an extensive and comprehensive failure investigation and risk assessment regarding this matter. After laboratory testing and a comprehensive literature review, Xoft has concluded that there is no evidence that these tungsten particles are toxic - only a few health effects have been reported in humans with this material, each of which involved exposure at much higher levels. No permanent impairment of bodily functions or permanent damage to body structures is anticipated.

Public Contact:

Steve Lin

Director, RA/QA

iCAD (formerly Xoft Inc)

345 Potrero Avenue

Sunnyvale, Calif. 94085

408-419-2300  

FDA District: San Francisco

FDA Comments:

On Feb. 3, 2011, the company sent an Urgent Field Removal Action letter to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer.

Customers were instructed to:

  • Stop using all units of the Flexishield Mini Catalog Number F5300 in their inventory  and return them to the company;
  • Fill out the iCAD Product Return Form and fax to the company at 866-222-3404;
  • Call iCAD's toll-free Customer Service at 877-963-8327 to make arrangements to return the product and receive a credit if applicable, and;
  • Complete and return the form to iCAD via fax even if they did not have any units to return.

It is recommended that health care professionals:

1. Inform the patient about the likelihood of post-operative tungsten particles in the breast.

2. Continue the imaging recommended in your clinical protocol for the full 5 years, unless otherwise directed by the patient's treatment team, to include:

a. Mammography every 12 months (6 months from breast MRI)

b. Breast MRI every 12 months (6 months from mammography)

c. Any additional imaging as determined by the responsible physician and tailored to the specific patient's needs

3.  Perform clinical examination of the breast, including palpation, preferably by a breast surgeon.

4.  Perform serum and urine testing for tungsten every 12 months until the tungsten concentration approaches that of the general population as reported by the Agency for Toxic Substances and Disease Registry (ATSDR).

Class 1 recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of these products will cause serious adverse health consequences or death.

Health care professionals and consumers may report adverse reactions or quality problems they experienced using these products to MedWatch: The FDA Safety Information and Adverse Event Reporting Program either online, by regular mail or by FAX.

SOURCE

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