Skip to content
Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 76821

1 recalled-product record grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
March 22, 2017
Product types
Device
Classifications
Class I
Statuses
Terminated
Recalling firm wording
ReFlow Medical

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 1

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

Z-1898-2017
Recall number
Z-1898-2017
Initiated
March 22, 2017
Classification
Class I
Status
Terminated
Recalling firm
ReFlow Medical
Quantity
2,794 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
ReFlow Medical is recalling the Wingman 35 Crossing Catheter because it may be prone to tip detachment.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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

Code information

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, 1508204R, 1508205, 1510074R, 1511304, 1512174,1512174R, 1602174, 1604213, 1604253, 1605113, 1606203, 1611034. Model No. WGM35065CE 1508074R, 150874R1, 1509154, 1510024, 1510024R, 1510054, 1602164R, 1604194, 1606273, 1606273R. Model No. WGM35090CE 1502053R, 1505144R, 1505144R1, 1505144R2, 1505144R3, 1508264, 1601044R, 1603024R, 1603024R2, 1603214R, 1603214R2, 1605194, 1605194R, 1605194R2. Model No. WGM35135CE 1503094R, 1503094R1, 1503094R2, 1505061R, 1505264, 1506104R, 1508204, 1508205R, 1510074, 1602174R, 1604213R, 1606203R, 1606203R2, 1606204, 1606204R, 1611114.

Distribution pattern

Worldwide Distribution - US Nationwide in the states of : NJ, FL, CA, GA, MI, OH and countries of: Germany, Turkey, and AU.