FDA Designates ReFlow Medical Inc.’s Recall of its Wigman35 Crossing Catheters A Class I
The U.S. Food and Drug Administration (FDA) just announced that it has classified the ReFlow Medical Inc. voluntary recall of one of its catheters as a Class 1 recall, the agency’s most serious classification.
According to the agency, recalls are actions that are taken by a firm—the maker of a drug, the maker of a medical device, or the maker of a consumer product, which may be anything such as toys, baby products, clothing, automobiles, bicycles, home appliances, office items, and food items—to remove a drug, medical device, or product from the consumer market. The FDA points out that recalls may be conducted on a firm’s own initiative, by the FDA’s request, or by FDA order under statutory authority.
In this case, the medical device maker issued the recall and the agency classified the recall. Typically, firm’s issue recalls and the FDA classifies them as a Class I, Class II, or Class III recall. A Class I recall involves “a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.” In this case, the violative product involved in the Class I recall is the ReFlow Medical Inc.’s catheter.
Specifically, the recall involves ReFlow Medical Inc.’s Wingman35 Crossing catheters. A total of 2,327 devices have been recalled and were distributed between January 2015 and March 2016, according to the federal regulators. This defect may lead to the need for additional medical involvement to either recover the detached portion of the Wingman35 Crossing catheter or stem the blood flow to end organs, according to Helio.com
To date, ReFlow Medical Inc. has received a total of two complaints and reported two adverse events, the FDA announcement indicated, according to Helio.com.
ReFlow Medical Inc. issued recall notification letters to distributors and customers. The letter indicated that the Wingman35 Crossing catheters should not be used. Any supplies of the recalled devices should also be quarantined and returned to ReFlow Medical Inc., according to the FDA announcement, Helio.com reported.
MedScape.com noted that the ReFlow Medical Inc.’s Wingman35 Crossing catheters recall was lot specific and was related to the two resulting adverse events, according to a ReFlow Medical Inc. statement that was posted on the FDA’s website.
“Tip splitting has the potential to lead to loss of device function. Tip separation may require medical intervention to retrieve a separated segment or may occlude blood flow to end organs,” Re-Flow Medical Inc. wrote in its statement, according to MedScape. In this case, occlusion means a blockage or closing of a blood vessel.
MedScape pointed out that, when the Wingman35 crossing catheters are returned to ReFlow Medical, customers and distributers are supposed to receive a credit for the return.
Parker Waichman LLP has spent decades representing clients in drug and medical device injury lawsuits. The firm continues to offer free legal consultations to individuals with questions about filing a ReFlow Medical Inc.Wingman35 Crossing catheter injury lawsuit.
What Are Catheters?
Cardiovascular Business noted that the Wingman35 Crossing catheters are used in the peripheral vasculature. The peripheral vascular system consists of the body’s veins and arteries that are not located in the chest or abdomen and are located, for example, in the arms, hands, legs, and feet. The peripheral arteries supply oxygenated blood to the body, while the peripheral veins lead de-oxygenated blood from the capillaries that are in the body’s extremities and to the heart. Peripheral veins are the most commonly used access for intravenous delivery in hospitals and paramedic services for a peripheral intravenous (IV) line for intravenous therapies. Sometimes, when blockages occur in the peripheral arteries, these blockages may be treated with either catheterization or balloon dilation as opposed to having to undergo surgery.
Meanwhile, in October 2014, the agency granted 510(k) clearance to the filing of approval or clearance of ReFlow Medical Inc.’s Wingman35 Crossing catheters. The catheters are used with steerable guide wires to reach discrete regions of the peripheral vasculature and allow for lesion crossing, according to Cardiovascular Business.
The 510(k) clearing route 510(k) route has been highly criticized in recent years as it bypasses clinical testing. The 510(k) route is a loophole in FDA regulations and under this process, device makers have the ability to bypass clinical testing of their products if a device is found to be substantially similar to an already approved device. Those opposed to this process say that devices cleared in this manner often include devices that have high failure rates such as metal-on-metal hip implants and transvaginal mesh devices, to name just two.
In 2016, Reflow Medical Inc., announced that a new United States patent entitled, “Systems, Methods, and Devices for Ablation, Crossing, and Cutting of Occlusions” for its Wingman Crossing Catheter technology. This patent covers one key differentiating feature, which has been incorporated into ReFlow’s group of peripheral and coronary crossing catheters, which are designed with an exclusive extendable bevel tip that is used in conjunction with steerable guide wires that the physician chooses. The device is meant to allow rapid, routine, off-the-shelf lesion crossing.
At the same time, ReFlow Medical Inc. also announced an exclusive U.S. distribution agreement with Maquet Medical USA for the peripheral line of catheters. “This marks an important milestone for our company,” said Isa Rizk, president and CEO of ReFlow Medical, Inc. “This granted patent helps protect the intellectual property of the company and further supports the differentiation of our product lines.” The ReFlow Medical Inc.’s product portfolio was also expanded to include the Wingman18 Crossing catheter. The Wingman35 Crossing catheter also enables physicians to use their .035 guide wire of choice
Filing a ReFlow Medical Wingman35 Crossing Catheter Device Lawsuit
If you or someone you know is interested in filing a personal injury lawsuit over a defective ReFlow Medical Wingman35 Crossing, contact Parker Waichman today. Our firm offers free, no-obligation case evaluations. For more information, fill out our online form or call 1-800-YOURLAWYER (1-800-968-7529).