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FDA Issues Class 1 Recall of Surgical Stapler

FDA Issues Class 1 Recall of Surgical Stapler

October 26, 2012 — Ethicon Endo-Surgery Inc. and the U.S. Food and Drug Administration (FDA) are announcing a voluntary Class 1 recall of several types of surgical staplers used in the repair of hemorrhoids and rectal prolapse. The problem is that the devices may be difficult to fire, which could cause a misfire or incomplete staple formation. The FDA warns that these device could cause “severe pain, sphincter dysfunction, rectal wall damage, sepsis, bleeding, and occlusion of the rectal canal.”

According to the FDA, these surgical staplers “may cause serious adverse health consequences, including death.” The administration has issued a Class 1 recall, which is the most urgent type of recall the FDA can issue. Class 1 recalls are reserved for devices or drugs that have a good chance of causing serious injury or death.

The recall was officially announced on August 3, 2012, and includes the following products:

  • 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)

These products were manufactured beginning in April 2011, and they were sold to customers between April 18, 2011 and July 23, 2012.

The circular surgical staplers are used to treat hemorrhoids and prolapse (a condition when weakened rectal tissue falls onto or through the anal opening). The FDA has approved these devices to treat obstructed defecation syndrome and anorectal wall defects.

The FDA also announced that they will be notifying customers about the recall via overnight mail, and customers will be asked to respond to the FDA regarding what action they plan to take.

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