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Ethicon Surgical Stapler

Johnson & Johnson Surgical Staplers & Life-Threatening Malfunctions

Surgical staplers are widely used in modern procedures to close incisions, reconnect tissue, and reduce operating time. When these devices fail, the consequences can be devastating.

In 2011, Johnson & Johnson’s Ethicon Endo-Surgery division issued a Class I FDA recall,the most serious type, on more than 157,000 hemorrhoidal circular staplers due to malfunction risks that could cause severe injury or death.

Carabin Law is investigating claims involving injuries caused by defective Ethicon surgical staplers, including misfires, incomplete staple formation, and internal damage.

Why the FDA Issued a Class I Recall

According to the FDA, the recalled Ethicon staplers were prone to difficulty firing or failing altogether during surgery. In some cases, surgeons were forced to abandon the device mid-procedure due to resistance or incomplete firing strokes.

Potential Complications from Stapler Malfunctions Include

  • Incomplete or malformed staple lines
  • Tissue tearing or internal perforation
  • Uncontrolled bleeding
  • Infection and sepsis
  • Organ damage
  • Death


Because these failures occur during surgery, patients are often unaware of the cause until severe complications arise post-operatively.

Reported Injuries Linked to Ethicon Stapler Failures

Malfunctioning surgical staplers can cause catastrophic internal injuries, particularly during colorectal and hemorrhoidal procedures.

Documented Injury Risks Include

  • Rectal wall tears or splitting
  • Occlusion of the rectal canal
  • Sphincter dysfunction
  • Severe and chronic pain
  • Excessive blood loss
  • Infection and sepsis
  • Emergency corrective surgery
  • Fatal outcomes

Many patients required additional surgeries, extended hospital stays, or long-term medical care due to these defects.

Reported Injuries Linked to Ethicon Stapler Failures

Malfunctioning surgical staplers can cause catastrophic internal injuries, particularly during colorectal and hemorrhoidal procedures.

Documented Injury Risks Include

  • Rectal wall tears or splitting
  • Occlusion of the rectal canal
  • Sphincter dysfunction
  • Severe and chronic pain
  • Excessive blood loss
  • Infection and sepsis
  • Emergency corrective surgery
  • Fatal outcomes

Many patients required additional surgeries, extended hospital stays, or long-term medical care due to these defects.

Ethicon Surgical Staplers Subject to Recall

Johnson & Johnson recalled multiple Ethicon stapler products, including:

PROXIMATE HCS Hemorrhoidal Circular Stapler & Accessories (33mm) Product Code: PPH01

PROXIMATE PPH Hemorrhoidal Circular Stapler & Accessories (33mm) Product Code: PPH03

TRANSTAR Circular Stapler Procedure Set Product Code: STR10


Manufactured:
April 16, 2011 – July 24, 2012

Distributed: April 18, 2011 – July 23, 2012

Johnson & Johnson later acknowledged that a manufacturing lubrication process change introduced in April 2011 contributed to the firing defects. The HCS stapler line was ultimately discontinued.

Injured? Contact Carabin Law

If you were harmed by a recalled or defective surgical stapler, Carabin Law is prepared to help.

Contact Carabin Law today for a FREE, confidential case review.
Our attorneys represent injured patients across Texas.