Provena Midline CK000917Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00801741187827), received between Mar 24, 2020 and May 6, 2026 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (6 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. 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 6, 2026Material Deformation

  IT WAS REPORTED THE SHEATH DOES NOT ENTER THE SKIN AS SMOOTHLY AS BEFORE AND TENDS TO CRUMPLE UP. NO INJURY TO PATIENT HAS BEEN REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25094544 ↗
• MalfunctionMay 6, 2026Material Deformation

  IT WAS REPORTED THE SHEATH DOES NOT ENTER THE SKIN AS SMOOTHLY AS BEFORE AND TENDS TO CRUMPLE UP. NO INJURY TO PATIENT HAS BEEN REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25094541 ↗
• MalfunctionJan 22, 2026Material Deformation; Difficult or Delayed Separation

  IT WAS REPORTED THAT THE DILATOR BROKE APART WHEN BEING USED IN THE PATIENT. NO PATIENT HARM WAS OBSERVED. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24147969 ↗
• MalfunctionDec 9, 2025Misassembled; Misassembled

  IT WAS REPORTED A NEEDLE OUTSIDE OF THE MIDLINE KIT. FORTUNATELY, NO ONE WAS POKED/INJURED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23758397 ↗
• MalfunctionDec 12, 2023Material Deformation; Material Deformation

  IT WAS REPORTED BY CUSTOMER THAT 3FR DILATORS ARE BUCKLING WHEN TRYING TO TRANSITION THROUGH SKIN. ADDITIONAL INFORMATION 6/19 IN INABILITY TO ADVANCE DILATOR AND SHEATH THROUGH SKIN REQUIRED ADDITIONAL SKIN NICK AND OBTAINING NEW 3 FR. DILATOR. NO URGENT/LIFE THREATING MEDICAL SITUATION. 12/08/2023 - TWO SAMPLES WERE RETURNED FOR INVESTIGATION. THE LEADING EDGE OF EACH MICROINTRODUCER WAS DAMAGED AND PLASTICALLY DEFORMED ON BOTH SAMPLES. THIS REPORT ADDRESSES THE SECOND SAMPLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18311960 ↗
• MalfunctionJun 30, 2023Material Deformation; Material Deformation

  IT WAS REPORTED BY CUSTOMER THAT 3FR DILATORS ARE BUCKLING WHEN TRYING TO TRANSITION THROUGH SKIN. ADDITIONAL INFORMATION 6/19, IN INABILITY TO ADVANCE DILATOR AND SHEATH THROUGH SKIN REQUIRED ADDITIONAL SKIN NICK AND OBTAINING NEW 3 FR. DILATOR. NO URGENT/LIFE THREATING MEDICAL SITUATION. ON 12/08/2023 - TWO SAMPLES WERE RETURNED FOR INVESTIGATION. THE LEADING EDGE OF EACH MICROINTRODUCER WAS DAMAGED AND PLASTICALLY DEFORMED ON BOTH SAMPLES. THIS REPORT ADDRESSES THE FIRST SAMPLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17239833 ↗
• MalfunctionMar 24, 2020Material Deformation; Material Deformation

  IT WAS REPORTED "DILATOR PEEL APART SHEATH, ISSUES CONTINUE, I WAS ABLE TO SALVAGE THIS 3 FR. MIDLINE IV DILATATOR, UNABLE TO USE THIS DILATOR DESPITE SKIN NICK. I AVOID SKIN NICKING." ADDITIONAL INFORMATION RECEIVED: 03/04/2020 - ATTEMPTING TO ADVANCE DILATOR AND SHEATH OVER WIRE, DEVICE WOULD NOT PENETRATE SKIN, BUCKLED AFTER MAKING SKIN NICK CONTINUED DIFFICULTY ADVANCING AFTER 3RD ATTEMPT TO ADVANCE SHEATH BECAME ACCORDION LIKE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9876077 ↗