Home › BOSTON SCIENTIFIC CORPORATION › Hydratome RX 44
Hydratome RX 44
BOSTON SCIENTIFIC CORPORATION · Model M00583050 · UDI-DI 08714729755203
KNS
Prescription
10
510(k) clearances
17,612
Adverse events (83 deaths)
125
Recalls
117
Facilities
Description
Sphincterotome
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-08-19 | Olympus Corporation of the Americas | Potential for detachment of ceramic tip due to manufacturing without the designated amount of adhesive. |
| 2026-08-19 | Olympus Corporation of the Americas | Potential for detachment of ceramic tip due to manufacturing without the designated amount of adhesive. |
| 2026-08-19 | Olympus Corporation of the Americas | Potential for detachment of ceramic tip due to manufacturing without the designated amount of adhesive. |
| 2026-08-19 | Olympus Corporation of the Americas | Potential for detachment of ceramic tip due to manufacturing without the designated amount of adhesive. |
| 2026-01-07 | Olympus Corporation of the Americas | Devices which did not undergo thermoforming could deform and lose performance. |
| 2026-01-07 | Olympus Corporation of the Americas | Devices which did not undergo thermoforming could deform and lose performance. |
| 2026-01-07 | Olympus Corporation of the Americas | Devices which did not undergo thermoforming could deform and lose performance. |
| 2026-01-07 | Olympus Corporation of the Americas | Devices which did not undergo thermoforming could deform and lose performance. |
| 2026-01-07 | Olympus Corporation of the Americas | Devices which did not undergo thermoforming could deform and lose performance. |
| 2026-01-07 | Olympus Corporation of the Americas | Devices which did not undergo thermoforming could deform and lose performance. |
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.