Skip to content

ORISE™ ProKnife M00519400Recalls & reported problems

Boston Scientific Corporation · ORISE 3.0 mm Electrode - Kitted Device · Class 2

All models of ORISE ProKnife (6)

Data updated Oct 16, 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 16, 2026.

Recalls naming this device

  1. Oct 10, 2022Open, Classified

    ***Update12/13/22***:Product removal due to higher incidence of adverse events of foreign body reactions*** Potential outcomes associated with foreign body reaction to remnant ORlSE Gel post procedure. Foreign body reaction which presented as mass formations from remnant ORlSE Gel post-procedure, prompting surgical intervention

    Z-0226-2023 · Root cause: Under Investigation by firm · 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