The Recall Desk
Agency classClass IOur severity:SevereFDA (Devices)·Z-1898-2017·Announced 2017-05-24

ReFlow Medical Recalls Wingman 35 Crossing Catheters Due to Tip Detachment Risk

ReFlow Medical is recalling Wingman 35 Crossing Catheters because they may be prone to tip detachment. The recall affects 2,794 units distributed in the US and internationally.

The agency’s classification

FDA (Devices): Class I

Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The agency classified this recall as Class I — a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death. On that classification alone this is scored Severe; a score of Critical is reserved for recalls where a death or serious injury was reported. The agency gives the reason as: "ReFlow Medical is recalling the Wingman 35 Crossing Catheter because it may be prone to tip detachment."

Plain-English summary

ReFlow Medical is voluntarily recalling the Wingman 35 Crossing Catheter, 65cm, because the device may be prone to tip detachment. The recall covers 2,794 units across various model numbers, including WGM35065US, WGM35090US, WGM35135US, and their CE counterparts.

The affected devices were distributed worldwide, including in the United States (specifically in New Jersey, Florida, California, Georgia, Michigan, and Ohio) and in Germany, Turkey, and Australia. Specific lot numbers for each model are listed in the official recall documentation.

Healthcare providers and consumers should stop using the affected catheters immediately. ReFlow Medical is the recalling firm and is responsible for managing the recall process.

The recalled product

Product
Wingman 35 Crossing Catheter, 65cm, Model Numbers: WGM35065US WGM35065CE WGM35090US WGM35090CE WGM35135US WGM35135CE
Manufacturer
ReFlow Medical
Category
Medical Device — Catheter
Hazard
Affected units
2,794

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

  • Lot Numbers Model number: WGM35065US 1508074
  • 1509154R
  • 1510204
  • 1510054R
  • 1602164
  • 1604194R
  • 1605133
  • 1606273R2
  • 1701244. Model number: WGM35090US 1502053
  • 1505144
  • 1508264R
  • 1508265
  • 1601044
  • 1603024
  • 1603214
  • 1605193
  • 1606304
  • 1610314. Model number: WGM35135US 1503094
  • 1505061
  • 1506104

Distribution

Distributed nationwide across the United States.

The notice also names 6 states specifically:

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