EndoRotor® Catheter 3.2mm x 1890mm ER 10-01-OPRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00854172008001), received between Nov 18, 2019 and Nov 18, 2019 — classified as 1 injury.

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.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryNov 18, 2019Adverse Event Without Identified Device or Use Problem

  THE PHYSICIAN WAS PERFORMING A RESECTION IN THE COLON OF A PREVIOUSLY RESECTED POLYP WITH SCAR TISSUE. AN INTERSCOPE REPRESENTATIVE WAS NOT PRESENT DURING THIS CASE. AT THE CONCLUSION OF THE PROCEDURE THE PHYSICIAN IDENTIFIED WHAT APPEARED TO BE A PARTIAL PERFORATION OF THE COLON. A FOLLOW ON CT SCAN CONFIRMED THE OBSERVATION THAT THE DEFECT WAS NOT A COMPLETE PERFORATION WITH PERITONEAL EXPOSURE. PATIENT WAS TREATED WITH THREE (3) ENDOSCOPIC CLIPS TO CLOSE THE DEFECT. PATIENT WAS PLACED ON ANTIBIOTICS AND KEPT IN HOSPITAL FOR OBSERVATION AND DISCHARGED THE FOLLOWING DAY. THERE WAS NO EVIDENCE OF A DEVICE MALFUNCTION AND THE DEVICE WAS NOT RETURNED FOR INVESTIGATION.

  Patient problems: Perforation

  MAUDE report 9337038 ↗