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Single Use Sphincterotome V KD-VC433Q-0730 (UDI 04953170371233)Recalls & reported problems

Olympus Medical Systems Corp. · Class 2

All models of Single Use Sphincterotome V (4)

Data updated Oct 18, 2026 from official FDA records · Editorial policy

1 open recall names 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
1

Summary

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

1 FDA recall record name this device's identifier, 1 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Recalls naming this device

  1. Jan 7, 2026Class IIOpen, Classified

    Devices which did not undergo thermoforming could deform and lose performance.

    Z-1284-2026 · Root cause: Process control · Recall details · FDA record ↗

Other Unit, electrosurgical, endoscopic (with or without accessories) devices

All Unit, electrosurgical, endoscopic (with or without accessories) devices →

Sources and updates

How reports and recalls are matched · Editorial policy · Report an error on this page