FDA Issues Class I Recall For Ethicon’s Circular Surgical Staplers
KBA previously noted problems with surgical staplers. Once again, defective surgical staplers are in the news.
Today, following the FDA’s March 2019 warnings to surgeons about the risks of surgical staplers, which noted over 41,000 adverse event reports, J&J’s Ethicon, issued the most urgent type of recall with respect to its circular surgical stapler, which was manufactured in the last year. According to Ethicon, there was a “shift in the process” and staples may not hold, placing patients at significant risk of very serious injuries, including death.
The most typical issues involving surgical staplers include an opening of the staple line, malformation of staples, and misfired or misapplied staples. Injuries resulting from this defect can result in additional surgeries and prolonged surgical procedures, along with the spread of infection, bleeding, sepsis, organ damage, and death.
Here are the details of the recalled surgical staplers:
What devices were recalled?
- Endo-Surgery Curved Intraluminal Stapler w/ Adjustable Height Staples
- Endo-Surgery Endoscopic Curved Intraluminal Stapler w/ Adjustable Height Staples
What are the device codes?
What are the dates related to the recall?
- Manufacturing dates between March 6, 2018 and March 6, 2019
- Distribution dates between March 15, 2018 and March 8, 2019
How many devices were recalled in the U.S.?
The FDA plans to issue draft guidance and recommendations concerning the use of all surgical staplers later this year to determine whether these devices should be reclassified, thus requiring premarket approval. After that happens, lawsuits may not be able to be brought in the future because of a legal doctrine called preemption. Still, Ethicon issued a recall of its circular surgical stapler in April, prior to any additional FDA guidance.
Injured patients should speak with a Defective Medical Device Attorney
KBA is investigating cases involving the failure of these surgical staplers, manufactured by Ethicon and Covidien. If you or a loved one suffered injuries during surgery as a result of the failure of a surgical stapler, please contact Derek Braslow at KBA Attorneys in order to have your potential case evaluated.
The lawyers at KBA have handled defective medical device litigation against Ethicon and Covidien for many years, including transvaginal mesh and hernia mesh. KBA has decades of experience litigating defective medical device cases and is here to help. Contact KBA Attorneys today.
FDA. “Ethicon Recalls Circular Staplers for Insufficient Firing and Failure to Completely Form Staples”, U.S. Department of Health and Human Services, https://www.fda.gov/medical-devices/medical-device-recalls/ethicon-recalls-circular-staplers-insufficient-firing-and-failure-completely-form-staples?utm_campaign=FDA%20MedWatch~Circular%20Staplers%20by%20Ethicon%3A%20Class%20I%20Recall&utm_medium=email&utm_source=Eloqua. Accessed May 16, 2019.
FDA. “Safe Use of Surgical Staplers and Staples – Letter to Health Care Providers“, U.S. Department of Health and Human Services, https://www.fda.gov/MedicalDevices/Safety/LetterstoHealthCareProviders/ucm632938.htm. Accessed March 28, 2019.