The United States Food and Drug Administration (FDA) has recently issued a recall of surgical staplers manufactured by Ethicon—a division of Johnson & Johnson. The recall comes after the device manufacturer confirmed serious injuries to two patients who were treated with the recalled devices. An article on the recall is available here.
About Surgical Staplers
Surgical staplers are designed to cut and seal blood vessels and tissue in order to close wounds and minimize blood loss during a procedure. When these devices fail; patients can bleed, suffer serious injuries, or even die. The FDA indicates the use of defective surgical staplers can lead to “bleeding, sepsis, tearing of internal tissues and organs, increased risk of cancer recurrence, and death.”
These surgical staplers are regulated as Class I Medical Devices—and do not require a premarket submission to the FDA. Such devices are commonly used by surgeons during a number of common gastrointestinal operations and other procedures.
About the Recall
The FDA recall affects over 92,000 surgical staplers produced by Ethicon. The action has been labeled a Class One Recall by the FDA—the strictest form of recall. This is an action reserved for cases where the use of a defective medical device may cause serious injury to patients—or even result in death. Ethicon has currently confirmed serious injuries to two patients treated with the recalled devices.
The FDA is considering a move to reclassify these surgical staplers as Class II Medical Devices. This would subject surgical staplers to premarket notification—and allow the FDA to establish additional regulations on the use of such devices.
We Can Help
If you or someone you love has suffered serious injuries or harmful side effects following the use of a surgical stapler made by Ethicon, Medtronics, or others; call the experienced Pennsylvania Defective Surgical Stapler Attorneys at Freeburn Hamilton for your free consultation.
When you call, you’ll speak with a leading Harrisburg Defective Medical Device Attorney for FREE. Freeburn Hamilton will fight hard to seek the justice and the compensation you deserve after an accident. Just call the 7’s for help at 717-777-7777 or 570-777-7777. There is no attorney’s fee due up front—and we only get paid after you do.