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Thomas Medical Products Issues Class I Recall

A defect in the company's Transseptal Sheath Introducer Kit may lead to serious complications

MONDAY, March 8 (HealthDay News) -- On March 5, the U.S. Food and Drug Administration and Thomas Medical Products Inc. (TMP) announced a Class I recall of the Transseptal Sheath Introducer Kit (other trade names include HeartSpan, CHANNEL FX, Torflex, and Braided Guiding Introducer Kit), as the sheath tip may break off and separate during heart procedures and lead to a blockage that may cause permanent injury such as a stroke, heart attack or death.

Transseptal sheaths are used to pass heart catheters from the right to the left side of the heart. If, during heart procedures, the sheath tip breaks off and separates, a fragment may lodge in a blood vessel serving a vital organ such as the brain or heart, causing serious injury.

On Feb. 1, TMP notified distributors of the recall, requesting that they stop distributing these devices and return all unused products. The defective devices were manufactured and distributed from Oct. 1, 2006, to Dec. 28, 2009, with affected lot ranges and catalog numbers listed in a Feb. 23 press release from the company.

"To date, TMP has received five adverse event reports in which the transseptal sheath introducer tip became fragmented/separated. These five occurrences were reported to affect health ranging from no clinical significance in four cases to tip fragment embolization in a coronary artery in the fifth case. This recall is intended to minimize future sheath breakage and adverse events," TMP noted in their press release.

More Information - FDA
More Information - TMP

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