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.
Do I have a Defective Medical Device Lawsuit?
The Schmidt Firm, PLLC is currently accepting defective surgical stapler induced injury cases in all 50 states. If you or somebody you know has been injured by a defective surgical stapler, you should contact our lawyers immediately for a free case consultation. Please use the form below to contact our Product Liability Litigation Group or call toll free 24 hours a day at (866) 920-0753.
Attention Lawyers: We consider a referral from another law firm to be one of the greatest compliments. If your firm is interested in referring us a case or for us to send you a list of previous award judgments and/or average referral fees, please visit the Lawyer Referral section of our website.