RX Cholangiogram Kit M00575360Recalls & reported problems
Boston Scientific Corporation · RX Cholangiogram Kit with Olympus Compatible Biopsy Cap · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
2 open recalls name this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 2
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 08714729750154), received between Jan 21, 2020 and Jan 21, 2020 — classified as 1 malfunction.
The most frequently reported specific device problem is “Break” (1 report).
2 FDA recall records name this device's identifier, 2 still open.
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
- Dec 22, 2021Open, Classified
Sterility of device is compromised due to a sterile barrier breach
Z-0781-2022 · Root cause: Packaging process control · FDA record ↗
- Dec 22, 2021Open, Classified
Sterility of device is compromised due to a sterile barrier breach
Z-0780-2022 · Root cause: Packaging process control · FDA record ↗
Most reported problems
Device problems
- Break1
Patient problems
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 21, 2020Break; Break
IT WAS REPORTED THAT RX CHOLANGIOGRAM WAS USED IN THE DUODENUM DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2019. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE CUTTING WIRE BROKE FROM DISTAL END OF CATHETER. REPORTEDLY, NO PART OF THE DEVICE WAS DETACHED INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE STABLE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9610260 ↗
Other Endoscopic Cholangiogram Kit devices
- RX Cholangiogram Kit M00575440Boston Scientific Corporation · Endoscopic Cholangiogram Kit2 recalls0 reports
- RX Cholangiogram Kit M00575480Boston Scientific Corporation · Endoscopic Cholangiogram Kit2 recalls0 reports
- RX Cholangiogram Kit M00575280Boston Scientific Corporation · Endoscopic Cholangiogram Kit2 recalls0 reports
- RX Cholangiogram Kit M00575400Boston Scientific Corporation · Endoscopic Cholangiogram Kit2 recalls0 reports
- RX Cholangiogram Kit M00575320Boston Scientific Corporation · Endoscopic Cholangiogram Kit2 recalls0 reports
- RX Cholangiogram Kit M00575380Boston Scientific Corporation · Endoscopic Cholangiogram Kit2 recalls0 reports
- RX Cholangiogram Kit M00575240Boston Scientific Corporation · Endoscopic Cholangiogram Kit2 recalls0 reports
- Cook G26908Cook Incorporated · Endoscopic Cholangiogram Kit1 report
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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