Wingman35 Crossing Catheters by ReFlow Medical: Recall - Tip Splitting or Separation
Audience: Risk Manager, Cardiology
[Posted 05/03/2017]
ISSUE: ReFlow Medical initiated a lot-specific voluntary recall of the Wingman35 Crossing Catheters. The Wingman35 Crossing Catheters have been found to exhibit tip splitting or separation, which has resulted in two adverse events. 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.
BACKGROUND: The Wingman Crossing Catheters in this recall were distributed between January 2015 and March 2016.
RECOMMENDATION: ReFlow Medical has notified its customers and distributors by recall notification letters. 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.
Consumers with questions may contact ReFlow Medical Customer Relations at 1-949-481-0399, Monday through Friday, between 8:00 a.m. and 4:30 p.m. Pacific time or by email at info@reflowmedical.com.
Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:
- Complete and submit the report Online: www.accessdata.fda.gov/scripts/medwatch/index.cfm
- Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
[05/03/2017 - Press Release - ReFlow Medical]
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