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.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class I, which indicates a reasonable probability that use of the product will cause serious adverse health consequences or death. The hazard of tip detachment in a medical device presents a significant risk of harm, fitting the 'High' severity criteria for risk-of-harm products.
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
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