ReFlow Medical Recalls Some Wingman35 Crossing Catheters

Megan Brooks

Disclosures

May 04, 2017

SAN CLEMENTE, CA — ReFlow Medical has initiated a lot-specific voluntary recall of the Wingman35 crossing catheters due to the possibility that the catheter tip may split or separate.

ReFlow has received two complaints of catheter-tip splitting and/or separation in the recalled catheters, resulting in two adverse events, the company said in a statement posted on the US Food and Drug Administration website[1].

"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," the company said.

The FDA has classified this as a class 1 recall, the most serious type, meaning the patient is exposed to a reasonable likelihood of death or a serious injury.

A total of 2327 Wingman catheters are in distribution for use in the peripheral vasculature according to product information on the company's website. The Wingman crossing catheters in this recall were distributed between January 2015 and March 2016.

ReFlow Medical has sent recall notification letters to its customers and distributors. The letters request that all customers and distributors quarantine and discontinue use of all potentially affected units and return the affected product to the company as soon as possible for credit.

Questions regarding this recall may be directed to ReFlow Medical Customer Relations at 1-949-481-0399, Monday through Friday, between 8:00 am and 4:30 pm Pacific time or by email at info@reflowmedical.com.

Healthcare providers are encouraged to report adverse events related to the use of this product to MedWatch, the FDA's safety information and adverse-event reporting program, by telephone at 1-800-FDA-1088; by fax at 1-800-FDA-0178; online; with postage-paid FDA form 3500; or by mail to MedWatch, 5600 Fishers Lane, Rockville, MD 20852-9787.

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