Recall Z-1898-2017— ReFlow Medical

Name: FDA recall Z-1898-2017
Creator: U.S. Food and Drug Administration
Published: 2017-03-22

Class I · Terminated

Class I FDA medical device recall by ReFlow Medical, initiated 2017-03-22, terminated 2017-12-06. It names one FDA 510(k) clearance: K141547. Product: Wingman 35 Crossing Catheter, 65cm, Model Numbers: WGM35065US WGM35065CE WGM35090US WGM35090CE WGM35135US WGM35135CE. Reason: ReFlow Medical is recalling the Wingman 35 Crossing Catheter because it may be prone to tip detachment..

Recalling firm: ReFlow Medical
Classification: Class I
Status: Terminated
Initiated: 2017-03-22
Terminated: 2017-12-06
Firm location: San Clemente, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K141547 — WINGMAN EXTENDABLE TIP SUPPORT CATHETERReflow Medical·cleared 2014-09-30

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Wingman 35 Crossing Catheter, 65cm, Model Numbers: WGM35065US WGM35065CE WGM35090US WGM35090CE WGM35135US WGM35135CE

Reason for recall

ReFlow Medical is recalling the Wingman 35 Crossing Catheter because it may be prone to tip detachment.

Data sourced from openFDA. This site is unofficial and independent of the FDA.