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MALVERN, PA – January 29, 2010 – Thomas Medical Products (TMP) formally announced today a worldwide voluntary recall of the SafeSheath^® CSG^® Sheath Introducer due to reported fragmentation and embolization of the radiopaque (RO) soft tip during use due to material degradation.   

SafeSheath^® CSG^® Sheath Introducer is a hemostatic introducer system with infusion side port that is intended for the introduction of various types of pacing or defibrillator leads, developed and manufactured by Thomas Medical Products, and distributed by Pressure Products, Inc. (PPI).

To date, TMP has received 38 adverse event reports in which the SafeSheath CSG introducer tip became separated.  In situations where this occurs in a patient with a cardiac septal defect or a patent foramen ovale (PFO), the sheath tip fragment could potentially pass from the right into the left cardiac chambers and systemic arterial circulation.  From there, the fragmented tip could embolize to any part of the body, including a vital structure such as the brain or heart, leading to permanent injury such as stroke or myocardial infarction.  This recall is intended to minimize future occurrences and adverse events.

TMP and PPI are notifying all customers about this recall through notices sent to each customer.  TMP and PPI are also arranging for return of all unused products.  Customers with questions may contact TMP at 1-866-466-3003 or tmpinfo@ge.com, between the hours of 8:30 AM to 5:00 PM EST. 

The recall encompasses products distributed from December 1, 2005 to December 14, 2009 and includes the following lot ranges and catalog numbers:

Lot Numbers:

Catalog Numbers:

TMP has informed the U.S. Food and Drug Administration (FDA) of this action.  Any adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

Online:www.fda.gov/medwatch/report.htm

Regular Mail: use postage-paid, pre-addressed Form FDA 3500 available at: www.fda.gov/MedWatch/getforms.htm. Mail to address on the pre-addressed form.

Fax: 1-800-FDA-0178