FDA Warning Letter
Prior to the voluntary recall by the manufacturer, the FDA sent a letter to health care providers in May 2019 about concerns connected to the stapler. According to the letter, between January 1, 2011 and March 31, 2018, the FDA received more than 41,000 adverse reaction reports for surgical staplers, including:
- 366 deaths
- Over 9,000 serious injuries
- Over 32,000 malfunctions
Per the letter, one of the most commonly reported problems was “opening of the staple line or malformation of the staples” which can cause:
- Bleeding
- Sepsis
- Fistula formation
- Tearing of internal tissues and organs
- Increased risk of cancer recurrence
- Death