FDA Issues Class 1 Recall of Surgical Stapler

October 26, 2012 — Today the U.S. Food and Drug Administration (FDA) announced a Class 1 recall of several hemorrhoidal circular staplers. The problem is that users may have difficulty firing the stapler, which could result in incomplete firing stroke or incomplete staple formation. According to the FDA, this could cause a patient to suffer “severe pain, sphincter dysfunction, rectal wall damage, sepsis, bleeding, and occlusion of the rectal canal.”

Class 1 recalls are the most urgent type of recall the FDA can issue, reserved for situations where a defective drug or product has a “good probability” of causing severe injury or death to a patient. The FDA warns that these defective staplers “may cause serious adverse health consequences, including death.”

The recalled products include:

• Ethicon PROXIMATE HCS Hemorrhoidal Circular Stapler and Accessories 33mm (Product Code: PPH01)
• Ethicon PROXIMATE PPH Hemorrhoidal Circular Stapler and Accessories 33mm (Product Code: PPH03)
• Ethicon TRANSTAR Circular Stapler Procedure Set (Product Code: STR10)

The products being recalled were manufactured by Ethicon Endo-Surgery Inc. between April 16, 2011 until July 24, 2012 and distributed from April 18, 2011 until July 23, 2012.

The hemorrhoidal circular staplers are used during surgical treatment of hemorrhoids and prolapse (when tissue in the rectum falls into or through the anal opening). The staplers repair rectal wall defects and obstructed defecation syndrome.

Ethicon initiated the voluntary recall on August 3, 2012. The FDA is also announcing the recall. Customers who purchased the devices will be notified via overnight mail and asked to respond to the FDA.

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