Flexima™ M001271800Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 08714729323310), received between Oct 26, 2018 and Jan 23, 2024 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Tear, Rip or Hole in Device Packaging” (5 reports).

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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 23, 2024Unsealed Device Packaging; Tear, Rip or Hole in Device Packaging; Unsealed Device Packaging; Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED THAT DEVICE PACKAGING SEAL WAS COMPROMISED. A 10.3 FLEXIMA DRAINAGE CATHETER WAS SELECTED FOR USE. HOWEVER, IT WAS NOTED THAT THERE WAS A HOLE IN THE PACKAGING, AND THE SEAL WAS COMPROMISED. THERE WAS NO PATIENT OR PROCEDURE INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18565438 ↗
• MalfunctionOct 25, 2022Contamination; Unsealed Device Packaging; Contamination; Unsealed Device Packaging

  IT WAS REPORTED THAT THE PACKAGE SEAL AND THE STERILITY OF THE DEVICE WERE COMPROMISED. A FLEXIMA DRAINAGE CATHETER WAS SELECTED FOR USE. DURING PREPARATION, THE CATHETER PACKAGE WAS RIPPED OPEN UPON TAKING OUT OF THE BOX. IT WAS NOTED THAT THE PACKAGE SEAL AND THE STERILITY OF THE DEVICE WERE COMPROMISED. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT CATHETER. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15670518 ↗
• MalfunctionOct 26, 2018Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED THAT THE DEVICE STERILITY WAS COMPROMISED. FOUR VTC/10.3 FLEXIMA DRAINAGE CATHETERS WERE DROP SHIP TO THE END USER. AFTER CHECKING THE ITEMS IN THE BOX, IT WAS NOTED THAT THE INSIDE OF THE PRODUCT, NOT THE BOX, WERE DAMAGED WITH TEARS IN THEM. THE PACKAGING OF THE ITEMS WERE TORN OPEN. THERE WAS NO PATIENT INVOLVEMENT REPORTED.

  Patient problems: No Patient Involvement

  MAUDE report 8010104 ↗
• MalfunctionOct 26, 2018Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED THAT THE DEVICE STERILITY WAS COMPROMISED. FOUR VTC/10.3 FLEXIMA DRAINAGE CATHETERS WERE DROP SHIP TO THE END USER. AFTER CHECKING THE ITEMS IN THE BOX, IT WAS NOTED THAT THE INSIDE OF THE PRODUCT, NOT THE BOX, WERE DAMAGED WITH TEARS IN THEM. THE PACKAGING OF THE ITEMS WERE TORN OPEN. THERE WAS NO PATIENT INVOLVEMENT REPORTED.

  Patient problems: No Patient Involvement

  MAUDE report 8010099 ↗
• MalfunctionOct 26, 2018Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED THAT THE DEVICE STERILITY WAS COMPROMISED. FOUR VTC/10.3 FLEXIMA DRAINAGE CATHETERS WERE DROP SHIP TO THE END USER. AFTER CHECKING THE ITEMS IN THE BOX, IT WAS NOTED THAT THE INSIDE OF THE PRODUCT, NOT THE BOX, WERE DAMAGED WITH TEARS IN THEM. THE PACKAGING OF THE ITEMS WERE TORN OPEN. THERE WAS NO PATIENT INVOLVEMENT REPORTED.

  Patient problems: No Patient Involvement

  MAUDE report 8010098 ↗
• MalfunctionOct 26, 2018Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED THAT THE DEVICE STERILITY WAS COMPROMISED. FOUR VTC/10.3 FLEXIMA DRAINAGE CATHETERS WERE DROP SHIP TO THE END USER. AFTER CHECKING THE ITEMS IN THE BOX, IT WAS NOTED THAT THE INSIDE OF THE PRODUCT, NOT THE BOX, WERE DAMAGED WITH TEARS IN THEM. THE PACKAGING OF THE ITEMS WERE TORN OPEN. THERE WAS NO PATIENT INVOLVEMENT REPORTED.

  Patient problems: No Patient Involvement

  MAUDE report 8010093 ↗