Thomas Medical Recalls Transseptal Sheaths

Shelley Wood

March 05, 2010

March 5, 2010 (Malvern, Pennsylvania) — The US FDA and Thomas Medical Products are alerting healthcare providers to a class I recall of the company's Transseptal Sheath Introducer Kit, marketed under the names HeartSpan, CHANNEL FX, Torflex, and Braided Guiding Introducer Kit [1]. The sheaths are used to pass cardiac catheters from the right to left heart, via the septum. According to a Medwatch Safety Summary, the tip of the device may break off and embolize while the sheath is in the coronary artery, leading to open heart surgery, MI, stroke, or death. Thomas Medical, a subsidiary of GE Medical, notes in a press release issued February 23 that, to date, five reports of tip fragmentation and separation have been reported, with four of these cases having "no clinical significance."

The recall covers products distributed between October 1, 2006 and December 28, 2009, with the full list of lot ranges and catalog numbers available here. The recall notice follows a note to distributors, February 1, asking them to stop distributing the products and returning them to the company.

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