TELEFLEX IPN050861Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 04026704323876), received between Mar 30, 2022 and Mar 30, 2022 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Sharp Edges” (3 reports).

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryMar 30, 2022Sharp Edges; Sharp Edges

  PATIENT CALLED IN AND STATED THAT HE WAS SEVERELY INJURED BY THE CATHETER HE RECEIVED FROM US. HE WAS HOSPITALIZED DUE TO THE CATHETER HAVING A SHARP POINT AT THE END, IT PUNCTURED HIM AND CAUSED BLEEDING. HE STATED HE FOUND 2 CATHETERS IN THE SHIPMENT HE JUST RECEIVED WITH THE POINT ON THE END. LOT KME21B0115.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 13952419 ↗
• MalfunctionMar 30, 2022Sharp Edges; Sharp Edges

  PATIENT CALLED IN AND STATED THAT HE WAS SEVERELY INJURED BY THE CATHETER HE RECEIVED FROM US. HE WAS HOSPITALIZED DUE TO THE CATHETER HAVING A SHARP POINT AT THE END, IT PUNCTURED HIM AND CAUSED BLEEDING. HE STATED HE FOUND 2 CATHETERS IN THE SHIPMENT HE JUST RECEIVED WITH THE POINT ON THE END. LOT KME21B0115.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 13952349 ↗
• MalfunctionMar 30, 2022Sharp Edges; Sharp Edges

  PATIENT CALLED IN AND STATED THAT HE WAS SEVERELY INJURED BY THE CATHETER HE RECEIVED FROM US. HE WAS HOSPITALIZED DUE THE CATHETER HAVING A SHARP POINT AT THE END IT PUNCTURED HIM AND CAUSED BLEEDING. HE STATED HE FOUND 2 CATHETERS IN THE SHIPMENT HE JUST RECEIVED WITH THE POINT ON THE END.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 13952315 ↗

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