Home › Myriad Medical, LLC › Prostate Caddy Rectal Balloon
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
| Date | Firm | Reason |
|---|---|---|
| 2025-02-04 | Angiodynamics, Inc. | Product is mislabeled with the incorrect fill volume. |
| 2024-05-21 | Angiodynamics, 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 |
Query this across every FDA database — by API.
Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.
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.
