ARROW IPN924158Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 10801902208627), received between May 1, 2024 and Dec 30, 2025 — classified as 2 injuries, 10 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (4 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 16, 2026.

Most reported problems

Recent adverse event reports

The 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 30, 2025Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE CATHETER "APPEARS TO BE LEAKING FROM THE WHITE LUMEN, INSIDE THE WHITE HUB. IF THE WHITE HUB AND TUBING WERE PERFECTLY STRAIGHT, IT DID NOT LEAK. IF THE TUBING WAS BENT OR ANGLED, THEN THE FLUIDS WERE LEAKING. ORIGINAL CATHETER WAS INSERTED ON (B)(6) 2025. IT IS A DOUBLE LUMEN PICC TRIMMED TO 25CM AND PLACED AS A TUNNELED CENTRAL LINE. GUIDE WIRE EXCHANGE COMPLETED ON (B)(6) 2025 DUE TO THE LEAKING CATHETER". NO PATIENT HARM OR INJURY. THE PATIENT STATUS IS REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23927164 ↗
• MalfunctionDec 30, 2025Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE CATHETER "APPEARS TO BE LEAKING FROM THE WHITE LUMEN, INSIDE THE WHITE HUB. IF THE WHITE HUB AND TUBING WERE PERFECTLY STRAIGHT, IT DID NOT LEAK. IF THE TUBING WAS BENT OR ANGLED, THEN THE FLUIDS WERE LEAKING. ORIGINAL CATHETER WAS INSERTED ON (B)(6) 2025. IT IS A DOUBLE LUMEN PICC TRIMMED TO 25CM AND PLACED AS A TUNNELED CENTRAL LINE. GUIDE WIRE EXCHANGE COMPLETED ON (B)(6) 2025 DUE TO THE LEAKING CATHETER". NO PATIENT HARM OR INJURY. THE PATIENT STATUS IS REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23927138 ↗
• InjuryNov 19, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT "ON (B)(6) 2025, PATIENT (B)(6), A 40-YEAR-OLD FEMALE, PRESENTED TO THE CLINIC FOR SCHEDULED DEVICE REMOVAL. SUBSEQUENTLY, THE PATIENT DEVELOPED A CATHETER-RELATED BLOODSTREAM INFECTION (CRBSI), WHICH WAS ASSESSED AS SEVERE IN INTENSITY. DUE TO THE PRESENCE OF BACTEREMIA, THE PATIENT REQUIRED HOSPITAL READMISSION. THE PERIPHERALLY INSERTED CENTRAL CATHETER (PICC) LINE WAS REMOVED ON THE SAME DAY FOLLOWING POSITIVE BLOOD CULTURE RESULTS. THE CLINICAL AND MICROBIOLOGICAL FINDINGS CONFIRMED THE DIAGNOSIS OF CRBSI." ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER STATES "PATIENT WAS SEPTIC BUT IT IS UNCLEAR IF THE ETIOLOGY IS DUE TO THE CRBSI OR WORSENING OSTEOMYELITIS. PATIENT HAD ALSO MISSED A WEEKS' WORTH OF ANTIBIOTICS PRIOR TO BEING RE-ADMITTED SO THIS COULD ALSO HAVE BEEN A CONTRIBUTING FACTOR." AFTER THE REMOVAL OF THE PICC LINE, PATIENT REMAINED ON IV AND ORAL ANTIBIOTICS AND WAS HOSPITALIZED FOR AN ADDITIONAL 6 DAY, THOUGH NOT IN THE ICU. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "STILL STRUGLING WITH OSTEOMYELITS, SHE IS IN STABLE CONDITION."

  Patient problems: Bacterial Infection

  MAUDE report 23595070 ↗
• InjuryNov 19, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT "ON (B)(6) 2025, PATIENT (B)(6), A 51-YEAR-OLD FEMALE, PRESENTED TO THE CLINIC FOR SCHEDULED DEVICE PLACEMENT. SUBSEQUENTLY, ON (B)(6) 2025, THE PATIENT DEVELOPED DEEP VEIN THROMBOSIS, WHICH WAS ASSESSED AS SEVERE IN INTENSITY. THE PATIENT WAS HOSPITALIZED FOR FURTHER MANAGEMENT."

  Patient problems: Thrombosis/Thrombus

  MAUDE report 23594915 ↗
• MalfunctionOct 28, 2025Fluid/Blood Leak; Material Puncture/Hole; Fluid/Blood Leak; Material Puncture/Hole

  IT WAS REPORTED THAT "DOUBLE LUMEN PICC PLACED ON (B)(6) 2025, AS OF TODAY BEDSIDE NURSE HAD GOOD BLOOD RETURN FROM BOTH LUMENS, BUT WHEN FLUSHED, THE PINK LUMEN WAS LEAKING FROM A HOLE IN THE EXTENSION TUBE." THERE WAS NO PATIENT HARM OR INJURY. NO MEDICAL INTERVENTION REQUIRED. THE PATIENT'S CURRENT CONDITION IS REPORTED A S "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23404614 ↗
• MalfunctionSep 19, 2025Fluid/Blood Leak; Stretched; Fluid/Blood Leak; Stretched

  IT WAS REPORTED "THE PICC LINE WAS PLACED AND 18 HOURS LATER THE LINE WAS LEAKING FROM THE HUB SO THEY CHECKED ON IT AND WERE NOT ABLE TO ASPIRATE SO THEY REMOVED IT. WHEN THEY REMOVED IT THEY DISCOVERED A BUBBLE BY THE 35CM MARKING." A NEW PICC LINE WAS INSERTED. THERE WAS NO PATIENT HARM OR INJURY. NO MEDICAL INTERVENTION REQUIRED. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23094724 ↗
• MalfunctionJul 31, 2025Leak/Splash; Leak/Splash

  IT WAS REPORTED "ORIGINALLY INSERTED ON (B)(6) 2025 AND REMOVED (B)(6) 2025 DUE TO LEAKING PROXIMAL PORT. LEAKING NOTICED COMING FROM UNDER THE WHITE PROXIMAL PORT. CATHETER WAS TRIMMED TO 30CM AND INSERTED LEFT IF AND TUNNELED AT TIME OF INSERTION. OUTPATIENT PROCEDURE. GUIDEWIRE EXCHANGE FOR A NEW TUNNELED CATHETER. PLACED A 55CM PICC TRIMMED AT 30CM. PATIENT HAS SHORT GUT SYNDROME AND HAS CONTINUOUS MEDICATIONS RUNNING 24 HOURS A DAY. HE WAS NOT ABLE TO TAKE A BREAK ON INFUSIONS BECAUSE ALL MEDS HAD TO RUN THROUGH THE ONE WORKING DISTAL LINE. HE HAD TO ELIMINATE SOME OF HIS FLUIDS DUE TO NOT HAVING 2 WORKING LINES OVER THE WEEKEND." THERE WAS NO PATIENT HARM OR INJURY. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22674711 ↗
• MalfunctionJul 9, 2025Leak/Splash; Leak/Splash

  IT WAS REPORTED "CATHETER WAS LEAKING FROM THE DISTAL LUMEN AT THE PINK HUB. " AN OVER WIRE EXCHANGE WAS PERFORMED TO REPLACE THE LINE. THERE WAS NO PATIENT HARM OR INJURY. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22457729 ↗
• MalfunctionMay 7, 2025Incorrect Measurement; Incorrect Measurement

  IT WAS REPORTED "PICC NURSE WAS PLACING PICC LINE ON PATIENT USING VPS G4 WHEN A BLUE BULLSEYE SHOWED ON THE SCREEN BUT 20CM OF CATHETER WAS OUT OF THE PATIENT. AFTER AN X-RAY, THE PICC TIP OF SHOWN TO BE LOCATED AT THE SUBCLAVIAN VEIN. PICC NURSE CONFIRMED THAT THE LINE WAS NOT IN A ARTERY. PATIENT WAS UNHARMED DURING THE PROCEDURE." THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21976414 ↗
• MalfunctionAug 28, 2024Material Deformation; Material Deformation

  IT WAS REPORTED THAT: "UPON INSERTION OF THE GUIDEWIRE THE INSERTER WENT TO SLIDE THE GLIDE THRU SHEATH ON TO THE WIRE WHEN HE FELT A "NOTCH" ON THE SIDE OF THE PLASTIC SHEATH. AT THAT POINT HE HAD TO OPEN A STAND ALONE SHEATH TO USE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20083674 ↗
• MalfunctionJun 25, 2024Material Separation; Material Separation

  IT WAS REPORTED "HANDLE OF THE SHEATH BROKE OFF DURING INSERTION. THE BREAK OF THE HANDLES HAPPENED IMMEDIATELY AFTER CRACKING THE HANDLES." THERE WAS NO PATIENT HARM OR INJURY. NO MEDICAL INTERVENTION REQUIRED. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19606135 ↗
• MalfunctionMay 1, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED "LINE WAS LEAKING WHERE THE LUMEN MEETS THE PINK HUB. LINE WAS IN FOR 6 MONTHS." NO PATIENT HARM OR INJURY. NO MEDICAL INTERVENTION REQUIRED. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19220218 ↗