Class I — ReFlow Medical
| Recalling firm | Reflow Medical |
|---|---|
| Registered facility | View this company's 2 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class I |
| Status | Terminated |
| Reason | ReFlow Medical is recalling the Wingman 35 Crossing Catheter because it may be prone to tip detachment. |
| Product | Wingman 35 Crossing Catheter, 65cm, Model Numbers: WGM35065US WGM35065CE WGM35090US WGM35090CE WGM35135US WGM35135CE |
| Quantity | 2,794 units |
| Distribution | Worldwide Distribution - US Nationwide in the states of : NJ, FL, CA, GA, MI, OH and countries of: Germany, Turkey, and AU. |
| Initiated | 2017-03-22 |
| Classified | 2017-05-12 |
| Terminated | 2017-12-06 |
| Recall number | Z-1898-2017 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class I recall — ReFlow Medical (Z-1898-2017).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/76821/
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