Injuries sustained due to faulty medical devices are a “hot topic” at LawInfo.com.  You can find a list of our “Hot Topics” on our homepage at LawInfo.com.

Another interesting recall is the voluntary Class I recall for PROXIMATE HCS Hemorrhoidal Circular Stapler and Accessories, PROXIMATE PPH Hemorrhoidal Circular Stapler and Accessories, and TRANSTAR Circular Stapler Procedure Sets manufactured by Ethicon Endo-Surgery Inc.  According to the FDA, Class I recalls are the most serious type of recall and may even cause death.  These recalled stapler sets are used in the surgical treatment of prolapse and hemorrhoids, along with surgical treatments of anorectal wall defects and obstructed defecation syndrome.

Recalled Product Information:

  • Recalling Firm: 
Ethicon Endo-Surgery Inc.
  • Product Names: PROXIMATE HCS Hemorrhoidal Circular Stapler (Product Code: PPH01) and Accessories, PROXIMATE PPH Hemorrhoidal Circular Stapler and Accessories (Product Code: PPH03), and TRANSTAR Circular Stapler Procedure Sets (Product Code: STR10)
  • Date Products were Manufactured: April 16, 2011 to July 24, 2012
  • Date Products were Distributed: April 18, 2011 to July 23, 2012 

Reason for Recall:

The stapler does not fire completely, causing incomplete staple formation.  Some consequences associated with the incomplete firing include:

  • Severe pain
  • Sphincter dysfunction
  • Rectal wall damage
  • Sepsis, bleeding
  • Occlusion of the rectal canal
  • Poor staple formation
  • Dehiscence of the rectal wall staple line
  • Bleeding
  • Death

Additional Information:

According to the FDA, letters will be mailed to customers who purchased the Ethicon devices.  Once customers receive this letter, they should respond to the Business Reply Form indicating:

  1. Whether they have the affected devices
  2. The quantity of affected devices, and
  3. If they have returned or will return the product(s)

Customers who have experienced negative reactions using these products, may report their adverse reactions or quality problems to MedWatch: The FDA Safety Information and Adverse Event Reporting Program.

What to Do if You Have Been Affected by a Recalled Product

If you or a loved one has become injured as a result of a recalled product, you may be entitled to compensation.  It would be beneficial to speak to an attorney specializing in products liability.  Most of the attorneys here at LawInfo.com offer free initial consultations, so it would be advantageous to at least talk to an attorney about your case and get some feedback.

 

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