OlyCath Curved 0 Eye 4 French
Promepla · Model ROTH4000ST245 · UDI-DI 03700512967965
EYB
Prescription
1
510(k) clearances
354
Adverse events (3 deaths)
4
Recalls
44
Facilities
Description
Ureteral catheter, L. 80cm curved open, without eye, 04 CH/Fr
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-05-04 | Medline Industries, LP | During an internal review, Medline identified representative samples did not meet applicable performance specifications. Identified issues include irregularities in catheter surfac |
| 2026-05-04 | Medline Industries, LP | During an internal review, Medline identified representative samples did not meet applicable performance specifications. Identified issues include irregularities in catheter surfac |
| 2022-07-29 | Hobbs Medical, Inc. | Device label display an incorrect expiration date, extends the shelf life of the product. Affected product distributed in the United States from 3/25/2018 to 9/28/2020, expiration |
| 2008-06-25 | Gyrus ACMI Corporation | Particulate matter in the catheter |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.