ARROW IPN033360Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10801902095371), received between Jul 14, 2023 and Jun 4, 2024 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Material Twisted/Bent” (2 reports).

4 other recalls cover devices cleared under the same FDA submission (K042126); they may or may not involve this specific model.

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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 4, 2024Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED "IN A SUBSEQUENT ATTEMPT, THE CATHETER PASSES WITHOUT DIFFICULTY. UPON CHECKING FOR RETURN, BUBBLING AND AIR LEAKAGE ARE OBSERVED IN THE CATHETER, SO IT IS RETRACTED A FEW CENTIMETERS AND IT IS OBSERVED THAT THE CATHETER IS BENT, HENCE IT IS DECIDED TO COMPLETELY REMOVE IT. THE CATHETER IS FOUND TO BE FRACTURED UPON INSPECTION. A NEW DEVICE IS REQUESTED, AND THE PROCEDURE IS REPEATED FOR THE INSERTION OF A 5FR DUAL-LUMEN PICC CATHETER INTO THE BASILIC VEIN OF THE LEFT UPPER LIMB." NO MEDICAL INTERVENTION REQUIRED. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19459771 ↗
• MalfunctionJun 2, 2024Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED "AFTER CATHETER INSERTION, ITS POSITION WAS VERIFIED BY X-RAYS, REVEALING CATHETER LOOPING IN THE SUBCLAVIAN VEIN. ATTEMPTS WERE MADE TWICE TO REPOSITION THE CATHETER WITHOUT SUCCESS. SUBSEQUENTLY, THE DECISION WAS MADE TO COMPLETELY REMOVE THE CATHETER AND REPEAT THE PROCEDURE WITH A NEW DEVICE. THIS TIME, THE PROCEDURE WAS PERFORMED WITHOUT COMPLICATIONS, RESULTING IN THE INSERTION OF A 5FR DOUBLE LUMEN PICC CATHETER IN THE BASILIC VEIN OF THE RIGHT UPPER LIMB." NO PATIENT HARM OR INJURY. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19444872 ↗
• MalfunctionMay 8, 2024Crack; Premature Separation; Crack; Premature Separation

  IT WAS REPORTED "THE PATIENT IS ADMITTED TO THE ICU TO PERFORM A PICC INSERTION PROCEDURE IN THE LEFT UPPER LIMB BASILIC VEIN, BY A TRAINED SENIOR NURSE. DURING THE PROCEDURE, AFTER INSERTING THE PEEL-AWAY, IT IS OBSERVED TO HAVE FISSURED DISTALLY, OBSTRUCTING CATHETER PASSAGE. THE UNIT IS IMMEDIATELY REMOVED, AND A NEW KIT IS REQUESTED FROM THE PHARMACIST." THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19271694 ↗
• MalfunctionAug 10, 2023Material Separation; Material Separation

  IT WAS REPORTED "CATHETER THAT AT THE MOMENT OF INSERTING AND PURGING AGAIN IT IS OBSERVED THAT IT IS BROKEN IN THE AND WHERE THE TWO LINES DIVIDE". A NEW CATHETER WAS INSERTED. THE PATIENT "HAD NO NEGATIVE CONSEQUENCES".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17504388 ↗
• MalfunctionJul 14, 2023Material Deformation; Material Deformation

  IT WAS REPORTED "THE PEELAWAY IS BROKEN" DURING USE WHILE TRYING TO PASS THE CATHETER AFTER DILATION. THE DEVICE WAS COMPLETELY REMOVED AND A NEW CATHETER AND SHEATH WERE USED. NO PATIENT HARM WAS REPORTED. THE PATIENT'S CONDITION IS REPORTED AS FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17324666 ↗
• MalfunctionJul 14, 2023Fluid/Blood Leak; Fluid/Blood Leak

  THE COMPLAINT IS REPORTED AS: "THE PATIENT PRESENTS A MEDICATION LEAKAGE AT THE INSERTION SITE OF THE PICC CATHETER. UPON REMOVAL, THE EXIT OF FLUID IS VERIFIED AND OBSERVED AT THE JUNCTION BETWEEN THE CATHETER AND THE BLUE SECURING PART. SUBSEQUENTLY, A SALINE SOLUTION TEST IS PERFORMED USING A SYRINGE, CONFIRMING THAT THE LIQUID LEAKAGE IS DUE TO A BREAKAGE IN THAT AREA. IT IS IMPORTANT TO NOTE THAT THE CATHETER HAD BEEN INSERTED APPROXIMATELY 24 HOURS AGO." IT WAS REPORTED A CRACK WAS OBSERVED. THE CATHETER WAS REMOVED AND A PERIPHERAL LINE WAS PLACED. THERE WAS NO HARM TO THE PATIENT. THE PATIENT'S CONDITION IS REPORTED AS FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17323707 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K042126. One submission often covers many models, so check the product and lot details in each record.

• Z-2378-2026 · Apr 21, 2026 · Open, Classified
  Description/REF: PI PICC: 3: 6FR x 55CM w CHG/ DLX-35563-HPKC; AGBA PICC: 2L 5.5 FR X 45 CM/ASK-44552-ABKB; AGBA PICC/DELTA KIT: 5.5 FR X 55 CM/ASK-45552-MHBV; AGBA PICC: 1L 4.5FR
• Z-2825-2015 · Aug 27, 2015 · Terminated
  Arrow Kits with Medtronic Covidien 0.9% Sodium Chloride Flush Syringes
• Z-2462-2015 · Jul 30, 2015 · Terminated
  PICC Kits with Peel-Away Sheath Component; catheter, intravascular, therapeutic, ultrasound Product Usage: catheter, intravascular, therapeutic, ultrasound
• Z-1503-2009 · Feb 11, 2009 · Terminated
  Arrow Peripherally Inserted Central Catheter