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Defective ReFlow Catheter Designated Class 1 Recall by FDA

May 8, 2017
Defective ReFlow Catheter Designated Class 1 Recall by FDA

The U.S. Food and Drug Administration (FDA) has announced the classification of a voluntary recall of ReFlow Medical's catheter as Class 1. This is the most serious kind of designation denoting "a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause adverse health consequences or death."

Affected Devices

According to the announcement from the FDA, the recall affects 2,327 devices that were distributed between January 2015 and March 2016. The Wingman35 Crossing Catheters by ReFlow Medical, have been found to have tip splitting or separation, which has allegedly resulted in two adverse events. ReFlow Medical said that in both cases, the problem was discovered before the devices were used in patients.

Tip splitting has the potential to lead to loss of device function. Tip separation may necessitate medical intervention to retrieve a separated segment or may block blood flow to organs, according to the FDA.

ReFlow Medical notified customers and distributors of the lot-specific voluntary recall and instructed them to quarantine and discontinue use of all affected units and return them to the company as soon as possible for credit.

Catheter Complications and Risks

A catheter is a flexible tube inserted into the body to allow the flow of fluid. The use of catheters include: administering medications, injecting contrast dye for angiogram procedures, removing small blood clots (thrombectomy) from arteries and veins, among other purposes.

However, there are some risk factors indicating defective catheters are causing serious injuries prompting approximately four million allegedly defective devices to be recalled from the market. Taking into consideration the number of reasonably common medical procedures for which catheters are routinely used, it is fair to assume catheter injury lawsuits will continue to emerge.

An initial problem of catheters appears to be the degradation and breakdown of materials that may lead to the fracture of catheter tips and separation of the catheter components. When pieces, or material of the catheter break away from the device and float freely in the bloodstream, serious injury or even death may occur. If this free-floating material migrates to the heart, lungs, or other vital organs, the results may prove fatal.

National law firm Parker Waichman LLP has extensive and successful experience in litigation regarding allegedly defective medical devices, including catheters. Attorneys at the firm are available to answer question for individuals seeking legal information concerning a potential lawsuit.

Other Class 1 Catheter Recalls

Other Class 1 Catheter Recalls

In the spring of 2016, Boston Scientific recalled all models of the Fetch 2 Aspiration Catheter which the FDA had designated as a Class 1 recall. The Fetch 2 Aspiration Catheter functioned by clearing blood clots from coronary arteries by the procedure known as thrombectomy. The long, flexible device pushes through the arteries and vacuums clots from blood vessels. This allows blood to flow more freely by removing any blockage or obstruction, according to Drugwatch.

The reason given for the recall was that the catheter shaft could break prior to or during the procedure, at various points along the device. If the breakage should occur while the device is in a patient, bits of the catheter may block blood supply to the heart or blood vessels, and would require surgical removal.

Another Class 1 recall issued December 9, 2016, involved the Centurion Convenience Kit containing Multi-Med Single Lumen Catheters. The recall was issued because there may have been an excess of materials at the tip of the catheter due to the manufacturing process. This could lead to serious complications if the excess material were to enter the patient's bloodstream.

"The catheters have a potential for excess material to remain at the tip of the catheter from the manufacturing process," the recall alert stated. "If this occurs, the excess material may separate from the catheter during use and could enter the patient's bloodstream. This can result in serious adverse health consequences such as the development of blood clots, embolism of the excess material to vital organs, or death."

In October 2016, recall of catheter products was triggered by an embolism risk. Medtronic voluntarily recalled four neurovascular products, according to the Wall Street Journal. The recall was issued because the coating on the devices allegedly could separate and enter the blood stream, causing blood clots.


Medical devices, including catheters, which leave fragments behind in the human body, create the potential of serious complications and problems for the patient. The presence of even tiny fragments has the potential of leading to overwhelming harm, including death, to a patient.

Legal Advice and Information Concerning Catheters

If you or someone you know has been injured by a medical device, including a catheter, you may have valuable legal rights. Parker Waichman LLP offers free, no-obligation case evaluations. We urge you to contact the personal injury lawyers at 1-800-YOURLAWYER (1-800-968-7529).

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