RUSCH IPN050938Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04026704318339), received between Mar 21, 2022 and Mar 21, 2022 — classified as 1 injury.

2 other recalls cover devices cleared under the same FDA submission (K000070); they may or may not involve this specific model.

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.

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.

• InjuryMar 21, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT STATED THEY USED ONE CATHETER AND THEY STARTED BLEEDING. NO OTHER DETAILS PROVIDED. ADDITIONAL INFORMATION: PATIENT ADVISED THAT THESE ARE CAUSING PAIN AND BLEEDING. NO INJURIES OR MEDICAL INTERVENTION WERE REPORTED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Pain

  MAUDE report 13839089 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K000070. One submission often covers many models, so check the product and lot details in each record.

• Z-2086-2019 · Jul 1, 2019 · Terminated
  Rusch EasyCath Kit
• Z-1732-2014 · May 21, 2014 · Terminated
  RUSCH Easy Cath Coude Kit, 10 FR, Rx Only, Sterile, Distributed by: Teleflex Medical, Research Triangle Park, NC 27708. A tubular device that is inserted through the urethera and