ARROW IPN929381Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10801902219203), received between Nov 21, 2025 and Dec 11, 2025 — classified as 1 injury, 3 malfunctions.

The most frequently reported specific device problem is “Material Separation” (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. 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 11, 2025Material Separation; Material Separation

  IT WAS REPORTED AN INCIDENT IS REPORTED DUE TO A POSSIBLE STRUCTURAL FAILURE OF A MEDICAL DEVICE, WITH SPONTANEOUS DISCONNECTION OF THE VENOUS BRANCH OF A HAEMODIALYSIS CATHETER, WITHOUT ANY TYPE OF TRACTION HAVING OCCURRED. THE DEVICE IN QUESTION WAS A 15 CM TRIPLE LUMEN HAEMODIALYSIS CATHETER MANUFACTURED BY ARROW. THE INCIDENT WAS IDENTIFIED DURING ROUTINE DRESSING OF A PATIENT UNDERGOING CONTINUOUS DIALYSIS. BLOOD LOSS WAS OBSERVED AND PROMPTLY CONTROLLED. THE CATHETER WAS IMMEDIATELY REPLACED WITH A GUIDE WIRE, WITHOUT THE PATIENT SUFFERING ANY CLINICAL DAMAGE. DIALYSIS WAS TEMPORARILY SUSPENDED AND RESUMED AFTER THE SITUATION WAS RESOLVED. THE PATIENT DID NOT DEVELOP ANY SIGNS OR SYMPTOMS DUE TO THE EVENT. ESTIMATED BLOOD LOSS WAS MINIMAL AS THE PROCEDURE WAS STOPPED PROMPTLY. ASSOCIATED MDR NUMBER INCLUDES: 3006425876-2025-01140.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 23777765 ↗
• MalfunctionDec 11, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT "THERE WAS A PREVIOUS INCIDENT ON (B)(6), IN WHICH THE ARTERIAL LUMEN RUPTURED NEAR THE CANNULA OF A CATHETER OF THE SAME MODEL, PLACED IN THE LEFT JUGULAR VEIN OF ANOTHER PATIENT ON (B)(6). IN THAT CASE, THERE WAS ALSO NO ASSOCIATED TRACTION. THE SITUATION WAS NOT FORMALLY REPORTED AT THE TIME, AND MANIPULATION WAS CONSIDERED AS THE CAUSE, ALTHOUGH THIS WAS NOT CONFIRMED. AT THE TIME OF THIS INCIDENT, BATCH: 71F24H0598 WAS AVAILABLE IN THE SERVICE. THIS IS AN INTENSIVE CARE UNIT WITH EXTENSIVE EXPERIENCE IN PERFORMING CONTINUOUS DIALYSIS TECHNIQUES AND SUCH EVENTS ARE UNCOMMON. THE REPETITION OF OCCURRENCES WITH SIMILAR CHARACTERISTICS RAISED CONCERNS ABOUT THE POSSIBILITY OF A STRUCTURAL FAILURE ASSOCIATED WITH THE MODEL OF CATHETER USED." THERE WAS NO PATIENT'S HARM OR INJURY AS THE PATIENT WAS ALREADY IN CRITICAL CONDITION. THERE WAS A DELAY TO THERAPY DUE TO A NEW HEMODIALYSIS CATHETER NEEDING TO BE INSERTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23777640 ↗
• InjuryNov 21, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT " USER FOUND THAT THE ARTERIAL LINE OF THE CATHETER HAD BROKEN NEAR THE INSERTION HUB." ADDITIONAL INFORMATION RECEIVED STATES "THE ISSUE WAS IDENTIFIED TOO LATE, RESULTING IN THE PATIENT EXPERIENCING BLOOD LOSS THAT REQUIRED THE ADMINISTRATION OF ONE UNIT OF BLOOD." THE PATIENT WAS IN CRITICAL CONDITION PRIOR TO USING THE DEVICE. IT WAS REPORTED "THE PATIENT PASSED AWAY DUE TO THEIR OVERALL CLINICAL CONDITION, UNRELATED TO THE INCIDENT".

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 23617461 ↗
• MalfunctionNov 21, 2025Break; Break

  IT WAS REPORTED THAT "THE VENOUS LINE ALSO BROKE NEAR THE INSERTION HUB." THE CATHETER WAS REPLACED. THERE WERE NO CONSEQUENCES TO THE PATIENT. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "PASSED AWAY DUE TO THEIR OVERALL CLINICAL CONDITION, UNRELATED TO THE INCIDENT".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23617364 ↗