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UroPass 61354BXRecalls & reported problems

Gyrus ACMI, LLC · UroPass Ureteral Access Sheath 13/15 Fr (4.3/5 mm) x 54 cm (5/PK) · Class 2

1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.

Adverse event reports
0
Deaths reported
0
Injuries reported
0
Recalls naming it
1

Summary

No MAUDE adverse event reports in our data reference this device identifier directly.

1 FDA recall record name this device's identifier, 1 still open.

1 other recall cover devices cleared under the same FDA submission (K051593); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

  1. Sep 11, 2024Open, Classified

    Exposure of the UroPass product to Ultraviolet ( UV ) Radiation can cause brittleness of the device dilator tip, which may lead to broken dilator tips in the package or in patients during surgical procedures.

    Z-0364-2025 · Root cause: Storage · FDA record ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K051593. One submission often covers many models, so check the product and lot details in each record.

  • Z-2401-2023 · May 19, 2023 · Open, Classified
    UroPass Ureteral Access Sheaths, 5 pieces/box

Other ACCESSORIES, CATHETER, G-U devices

All ACCESSORIES, CATHETER, G-U devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.