Provena MidlineRecalls & reported problems across all models

We found 10 models of Provena Midline by Bard Access Systems, Inc. in the FDA's device registry (GUDID). Together they are named in 17 adverse event reports in the FDA's MAUDE database, received between Mar 24, 2020 and Sep 16, 2026 — classified as 2 injuries, 15 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (10 reports).

1 FDA recall record name at least one of these models by its device identifier, 1 still open.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Provena Midline recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

1. May 21, 2026Open, Classified

   Due to lidocaine ampoules being manufactured under deficient manufacturing practices by manufacturer, lidocaine ampoules are currently being recalled by supplier.

   Z-2667-2026 · Root cause: Nonconforming Material/Component · names 3 of these models · Recall details · FDA record ↗

Most reported Provena Midline problems

Provena Midline models

10 models, most reported first. Each model has its own page with its reports, recalls and device details.

• Provena Midline CK000880

  Midline catheter
  1 recall0 reports
• Provena Midline S4254108DCP

  Midline catheter
  1 recall0 reports
• Provena Midline S4153108DCP

  Midline catheter
  1 recall0 reports
• Provena Midline CK000917

  Midline catheter
  7 reports
• Provena Midline SP4254108DC

  Midline catheter
  3 reports
• Provena Midline CK000879

  Midline catheter
  2 reports
• Provena Midline CK000990A

  Midline catheter
  2 reports
• Provena Midline CK000970

  Midline catheter
  1 report
• Provena Midline CK000989

  Midline catheter
  1 report
• Provena Midline SP4153108DC

  Midline catheter
  1 report

Recent Provena Midline adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionSep 16, 2026Material Deformation

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50791400 ↗
• InjuryJun 15, 2026Material Frayed

  IT WAS REPORTED TIP OF THE WIRE BROKE OFF WITHIN THE PATIENT DURING REMOVAL. IT STILL REMAINS IN THE UPPER EXTREMITY RIGHT ARM, BASILIC VEIN. PATIENT EXPERIENCING NO SYMPTOMS. THERE ARE NO PLANS TO REMOVE WIRE. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 25511626 ↗
• 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 ↗
• MalfunctionFeb 2, 2026Contamination /Decontamination Problem

  IT WAS REPORTED BY CUSTOMER THAT HAD MIDLINE INSERTION KIT WITH HAIR FOUND IN THE STERILE FIELD. NO FURTHER DETAILS AVAILABLE OR PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24238163 ↗
• MalfunctionFeb 2, 2026Contamination /Decontamination Problem

  IT WAS REPORTED BY CUSTOMER THAT HAD MIDLINE INSERTION KIT WITH HAIR FOUND IN THE STERILE FIELD. NO FURTHER DETAILS AVAILABLE OR PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24238156 ↗
• 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 ↗
• InjurySep 17, 2025Failure to Infuse; Failure to Infuse

  THE CUSTOMER REPORTED USING A CATHETER THAT ENCOUNTERED "SIGNIFICANT ISSUES". ADDITIONAL INFORMATION RECEIVED 9/2/2025: CUSTOMER CONFIRMED THEY PLACED A PROVENA MIDLINE THAT WAS REMOVED AFTER A CONFIRMED DVT. THE PATIENT WAS HYPERCOAGULABLE AND HAD 2 SUBSEQUENT MIDLINE CATHETERS AND SEVERAL PERIPHERAL IVS OCCLUDE AFTER THE DOUBLE LUMEN PROVENA MIDLINE. THE OCCLUSIONS DID CAUSE DELAYS IN IV INFUSION THERAPY TREATMENT BUT "THEY WERE SEEMINGLY UNAVOIDABLE DUE TO THE PATIENT'S CONDITION". THE PATIENT WAS EVENTUALLY PLACED ON A HEPARIN DRIP; HOWEVER IT WAS DELAYED INITIALLY DUE TO A REPORT OF EXCESSIVE BLEEDING RISK WITH SUBCUTANEOUS ANTICOAGULATION. THERE WERE NO LONG-TERM EFFECT NOTED.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 23072502 ↗
• MalfunctionSep 4, 2025Improper or Incorrect Procedure or Method; Failure to Infuse; Improper or Incorrect Procedure or Method; Failure to Infuse

  IT WAS REPORTED THERE IS CONCERN FOR INTRAVASCULAR CRYSTALLIZATION WHEN INCOMPATIBLE MEDICATIONS ARE DELIVERED THROUGH SEPARATE LUMENS OF THE 2 LUMEN PROVENA MIDLINE CATHETERS. THIS ISSUE MAKES THE PRODUCT INAPPROPRIATE AS IT CONFUSES BEDSIDE RNS WHO ARE ACCUSTOMED TO 2 LUMEN PICC LINES WHICH ARE SIMILAR IN APPEARANCE, OCCUPY THE SAME UPPER ARM VASCULATURE, AND ARE CAPABLE OF INFUSING INCOMPATIBLE MEDS THROUGH SEPARATE LUMENS. THIS INCOMPATIBILITY ISSUE DID NOT ARISE FROM A CONFIRMED ADVERSE EVENT; HOWEVER, WE PLACED TWO DOUBLE LUMEN PROVENA MIDLINES BEFORE REMOVING THEM FROM DEVICE CIRCULATION DUE TO PERSISTENT REPORTS OF OCCLUSION AND SUBSEQUENT CONCERN FOR INFILTRATION SHORTLY AFTER INSERTION OF BOTH LINES. WE BELIEVE THESE LINES WERE POSSIBLY USED TO ADMINISTER INCOMPATIBLE MEDICATIONS WHICH LED TO DEVICE MALFUNCTION BEFORE THEIR REMOVAL. TWO PATIENTS EXPERIENCED SYMPTOMS OF INFILTRATION WITH PAIN AND SWELLING NEAR THE IPSILATERAL SHOULDERS, HOWEVER, VENOUS US WAS PERFORMED AND RESULTED IN NEGATIVE FINDINGS FOR MECHANICAL OCCLUSIONS. LINES WERE BOTH PULLED PRIOR TO VAT ASSESSMENT. ANTIDOTES FOR POSSIBLE INFILTRATION WERE NOT ADMINISTERED BUT WARM COMPRESSES WERE APPLIED TO EASE

  Patient problems: Pain; Swelling/ Edema

  MAUDE report 22967895 ↗
• MalfunctionApr 17, 2024Material Deformation; Material Deformation

  IT WAS REPORTED BY THE CUSTOMER THAT TRANSITION FROM THE PEEL AWAY SHEATH WILL ROLL UP ON TISSUE. IT SPLITS IT AND HAVE TO GET A NEW ONE. IT IS SOMETHING WITH THE TRANSITION THAT CATCHES. HAVE TO GO BACK IN AND KNICK A SECOND TIME TO TRY TO ADVANCE THE INTRODUCER. THERE WERE NO ADVERSE EVENTS TO THE PATIENT OR HEALTHCARE PROFESSIONAL. NO OTHER INFORMATION WAS PROVIDED. A SPECIFIC NUMBER OF AFFECTED DEVICES OR PATIENTS WAS NOT PROVIDED BY THE COMPLAINANT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19127841 ↗
• 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 ↗
• MalfunctionOct 26, 2023Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED BY CUSTOMER THAT TPA WAS GIVEN THROUGH A MIDLINE THEY WERE TOLD WAS A PICC BUT THE LETTERS ON SAID LINE WERE RUBBED OFF EXCEPT P AND HALF AN O. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18014093 ↗
• 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 ↗
• MalfunctionMay 4, 2023Material Deformation; Material Deformation

  IT WAS REPORTED BY THE CUSTOMER THAT "I DID A 3 FR AND COULDN'T ADVANCE THE INTRODUCER BECAUSE A LIP FORMED ON THE END AND WOULDN'T PENETRATE THE VEIN." NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16872967 ↗

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