TELEFLEX IPN050883Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04026704331062), received between Aug 29, 2023 and Aug 29, 2023 — classified as 1 malfunction.

The most frequently reported specific device problem is “Use of Device Problem” (1 report).

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.

• MalfunctionAug 29, 2023Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT "PATIENT SAID THAT THESE ARE CAUSING BLEEDING. NO MEDICAL ATTENTION REPORTED". AT THE TIME OF THIS REPORT THE CUSTOMER HAS NOT RETURNED OUR REQUESTS FOR ADDITIONAL INFORMATION. IF ADDITIONAL INFORMATION IS RECEIVED, THE COMPLAINT FILE WILL BE UPDATED.

  Patient problems: Exsanguination; Insufficient Information

  MAUDE report 17642236 ↗

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