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Prostate Caddy Rectal Balloon

Myriad Medical, LLC · Model 9901 · UDI-DI 10860005263124

PCT Prescription
5
510(k) clearances
1
Adverse events
2
Recalls
7
Facilities

Description

Prostate Immobilization device. Rectal Balloon with inflation syringe, single use, non-sterile. Box of 25.

Recalls

DateFirmReason
2025-02-04Angiodynamics, Inc.Product is mislabeled with the incorrect fill volume.
2024-05-21Angiodynamics, Inc.A single batch of ISO-100 IsoLoc Gas-Release Endorectal Balloons is mislabeled. The affected ISO-100 balloon catheter has a nominal fill volume of 100cc/ml but the inner pouch iden

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Data 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.