Severity
Critical
CriticalClass ITerminated
FDA Devices recall · Reported May 24, 2017
Wingman 35 Crossing Catheter, 65cm, Model Numbers: WGM35065US WGM35065CE WGM35090US WGM35090CE WGM35135US WGM35135CE
ReFlow Medical is recalling the Wingman 35 Crossing Catheter because it may be prone to tip detachment.
ReFlow Medical recalled Wingman 35 Crossing Catheter, 65cm, Model Numbers: WGM35065US WGM35065CE WGM35090… - a critical-severity action.
Wingman 35 Crossing Catheter, 65cm, Model Numbers: WGM35065US WGM35065CE WGM35090… was recalled by ReFlow Medical in May 24, 2017. Reason: ReFlow Medical is recalling the Wingman 35 Crossing Catheter because it may be prone to tip detachment.. Check the official notice for the remedy. Verify recall #Z-1898-2017 with the FDA Devices before acting.
The recall
ReFlow Medical issued this critical-severity FDA Devices recall-ReFlow Medical is recalling the Wingman 35 Crossing Catheter because it may be prone to tip detachment..
- Critical
- severity level
- 3K units
- affected scope
- Class I
- classification
- May 24, 2017
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-1898-2017 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-1898-2017) was formally reported on May 24, 2017, with the manufacturer initiating the action on March 22, 2017. It is classified under Critical severity (Class I), with a current status of Terminated. ReFlow Medical is listed as the recalling firm, operating out of San Clemente, CA. Federal records list the affected scope as 2,794 units.
The documented reason for this recall is: ReFlow Medical is recalling the Wingman 35 Crossing Catheter because it may be prone to tip detachment. Distribution data in the federal record shows the product reached: Worldwide Distribution - US Nationwide in the states of : NJ, FL, CA, GA, MI, OH and countries of: Germany, Turkey, and AU.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified high severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
2,794 units
Related Recalls
6
3 from same agency
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.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Critical (Class I) |
| Status | Terminated |
| Recall number | Z-1898-2017 |
| Date reported | May 24, 2017 |
| Date initiated | March 22, 2017 |
| Recalling firm | ReFlow Medical |
| Firm location | San Clemente, CA |
| Affected scope | 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. |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-1898-2017) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- This is a Class I (high-risk) recall, stop using the product immediately and follow the disposal or return instructions. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
Wingman 35 Crossing Catheter, 65cm, Model Numbers: WGM35065US WGM35065CE WGM35090US WGM35090CE WGM35135US WGM35135CE. Recalled by ReFlow Medical. Units affected: 2,794 units.
Why was this product recalled? ▼
ReFlow Medical is recalling the Wingman 35 Crossing Catheter because it may be prone to tip detachment.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on May 24, 2017. Severity: Critical. Recall number: Z-1898-2017.
Where was the recalled product distributed? ▼
Distribution: Worldwide Distribution - US Nationwide in the states of : NJ, FL, CA, GA, MI, OH and countries of: Germany, Turkey, and AU..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-1898-2017) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported May 24, 2017. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.