Provena Midline SP4254108DCRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00801741233227), received between Sep 4, 2025 and Jun 15, 2026 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Failure to Infuse” (2 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• 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 ↗