#REFLOW MEDICAL DOWNLOAD#
Regular Mail or Fax: Download form or call 1- 80 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-80.Pacific time or by email at reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax. The letters requested 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.įDA and other regulatory agencies around the world have been notified of this action.Ĭonsumers with questions may contact ReFlow Medical Customer Relations at 1-94, Monday through Friday, between 8:00 a.m. ReFlow Medical has notified its customers and distributors by recall notification letters. The Wingman Crossing Catheters in this recall were distributed between March 2015 and March 2017. Tip separation may require medical intervention to retrieve a separated segment or may occlude blood flow to end organs. Tip splitting has the potential to lead to loss of device function. A total of 2327 Wingman catheters are in distribution. LOWELL, Mass., Anuncia Inc. ReFlow has received 2 complaints of catheter-tip splitting and/or separation. Anuncia’s breakthrough technology has received an honorable mention in the Health category of this year’s World Changing Ideas Awards.
The Wingman35 Crossing Catheters have been found to exhibit tip splitting or separation, which has resulted in two adverse events. The FDA is classifying this as a Class 1 recall, the most serious recall situation where the patient is exposed to a reasonable likelihood of death or a serious injury. On April 22, 2017, ReFlow Medical initiated a lot-specific voluntary recall of the Wingman35 Crossing Catheters.