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RX Cholangiogram Kit M00575380Recalls & reported problems

Boston Scientific Corporation · RX Cholangiogram Kit with Olympus Compatible Biopsy Cap · Class 2

2 open recalls name 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
2

Summary

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

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

  1. 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 ↗

  2. 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 ↗

Other Endoscopic Cholangiogram Kit devices

All Endoscopic Cholangiogram Kit devices →

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