ARROW IPN924168Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 10801902208726), received between Feb 9, 2024 and Feb 10, 2026 — classified as 1 injury, 10 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 10, 2026Material Split, Cut or Torn

  IT WAS REPORTED THAT "INTRODUCER SHEATH SPLIT PREMATURELY AS IT WAS BEING ADVANCED OVER THE WIRE". THE INTRODUCER WAS NOT FULLY PLACED INTO THE PATIENT. IT STARTED SPLITTING AT THE SKIN AND WAS IMMEDIATELY DISCARDED AND REPLACED WITH A NEW SHEATH. THERE WAS NO PATIENT HARM OR INJURY. NO MEDICAL INTERVENTION REQUIRED. THE PATIENT'S CURRENT CONDITION IS UNKNOWN AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24304180 ↗
• MalfunctionMar 25, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT DURING THE PICC LINE INSERTION, THE GUIDE WIRE SHEARED, AND THE DLX DID NOT PICK UP THE STYLET. ADDITIONALLY, THE PICC DID NOT DROP AS EXPECTED. THE PATIENT WAS THEN TRANSFERRED TO THE INTERVENTIONAL RADIOLOGY (IR) TO COMPLETE THE PICC INSERTION. THE PATIENT HAD NO HARM OR INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21688932 ↗
• InjuryJan 30, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED "WE HAD A PATIENT THEY FEEL WENT INTO ANAPHYLAXIS WHILE THE PICC WAS INSERTED THE OTHER DAY". ADDITIONAL INFORMATION FROM THE HOSPITAL INDICATED THAT THE PATIENT EXPERIENCED DIAPHORESIS, ITCHING, DIFFICULTY BREATHING AND SEIZURE LIKE MOVEMENTS. THE PATIENT WAS TREATED WITH EPINEPHRINE AND STEROIDS AND WAS UNDER MONITORING. THE CONDITION OF THE PATIENT IS REPORTED AS 'STABLE' AND THE PATIENT RETURNED TO THE PREVIOUS HEMODYNAMICS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21274154 ↗
• MalfunctionJun 6, 2024Difficult to Advance; Material Deformation; Difficult to Advance; Material Deformation

  IT WAS REPORTED "SHEATH REPORTED AS LOOSE AND BECOMING DISCONNECTED FROM DILATOR WHILE ATTEMPTING TO ADVANCE. THIS IS HER 2ND TIME USING KITTING/PRODUCT. WHILE ATTEMPTING TO ADVANCE, SHE HAD NOTICED BURRING OF THE SHEATH. IT IS POSSIBLE THIS MAY HAVE BEEN USER RELATED AS HER TECHNIQUE WAS ALTERNATING BETWEEN CLOCKWISE TWISTING AND COUNTER-CLOCKWISE TWISTING WITH THE INTRODUCER WITHIN THE SKIN, BUT SHEATH REMAINING OUTSIDE TISSUE. SHEATH WAS REMOVED WITHOUT ISSUE FROM GUIDEWIRE, OBSERVED MUSHROOMING FROM SHEATH PEELING BACKWARD FROM FORCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19476235 ↗
• MalfunctionMay 6, 2024Unraveled Material; Unraveled Material

  IT WAS REPORTED "SPOKE WITH THE INSERTER WHO TOLD ME THAT DURING TROUBLE NEEDLING, THAT THE GUIDEWIRE UNRAVELED WHILE SHE PULLED IT BACK THROUGH THE NEEDLE. PT WAS TAKEN TO INTERVENTIONAL RADIOLOGY TO ENSURE SAFE REMOVAL OF THE ENTIRE WIRE." NO PATIENT HARM OR INJURY. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19248666 ↗
• MalfunctionMar 15, 2024Material Deformation; Material Deformation

  IT WAS REPORTED THAT: PEEL AWAY BUNCHED UP, THE REPORTED DEFECT WAS DETECTED DURING USE ON PATIENT. THE PATIENT CONDITION WAS REPORTED AS "FINE". NO PATIENT INJURY/CONSEQUENCE OR MEDICAL INTERVENTION REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18911706 ↗
• MalfunctionMar 8, 2024Material Deformation; Material Deformation

  IT WAS REPORTED "" DURING PICC INSERTION, INSERTER MET RESISTANCE AS CATHETER INSERTED. MANEUVERING TECHNIQUES WERE USED TO ADVANCE THE PICC UNSUCCESSFULLY. THE STYLET WIRE WAS ATTEMPTED TO BE REMOVED AND RESISTANCE MET. WIRE WAS FULLY RETRIEVED AND NOTED TO BE BENT. STYLET WIRE EXCHANGED WITH NEW ACCESSORY WIRE AND PICC UNABLE TOBE ADVANCED. INSERTER THEN TRIED TO REMOVE PICC AND WAS UNABLE REMOVE. PICC COULD NOT BE FLUSHED HOWEVER WIRE COULD BE REMOVED. AS THE PEEL AWAY SHEATH WAS BROKEN AND REMOVED THE PICC CATHETER FINALLY GAVE WAY AND COULD BE REMOVED." NO PATIENT HARM OR INJURY. NO MEDICAL INTERVENTION REQUIRED. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE". ASSOCIATED MDR NUMBER INCLUDE 9680794-2024-00092 AND 9680794-2024-00155.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18867887 ↗
• MalfunctionMar 6, 2024Fluid/Blood Leak; Material Split, Cut or Torn; Fluid/Blood Leak; Material Split, Cut or Torn

  IT WAS REPORTED THAT: PATIENT CAME TO ED WITH PICC IN PLACE WITH COMPLAINT OF LEAKING FROM EXTENSION LINE. TUBING NOTED TO BE POSSIBLY CUT OR SEPARATED? ADDITIONAL INFORMATION: THE LINE WAS BEING MANAGED AND ACCESSED BY HOME HEALTH WHO MAY HAVE ACCIDENTALLY CUT THE LINE WHILE CHANGING THE DRESSING. THE PATIENT WENT TO ED AND PART OF THE EXTENSION LINE WAS MISSING. THE LINE WAS REMOVED AND REPLACED IN ED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 18847157 ↗
• MalfunctionFeb 19, 2024Difficult to Advance; Material Deformation; Difficult to Advance; Material Deformation

  IT WAS REPORTED "SHEATH OVER DILATOR BUCKLED. INSERTER PLACED DILATOR/SHEATH OVER THE GUIDEWIRE TO PLACE INTO PATIENT. SHEATH PUSHED BACK (BUCKLED). THE PATIENT WAS REPORTED TO HAVE TOUGH SKIN. CLINICIAN ADVISED REMOVE SHEATH FROM DILATOR AND DILATE SKIN FIRST IN C CIRCUMSTANCES W/ TOUGH SKIN. CLINICIAN BELIEVES THIS COULD BE A FAULTY SHEATH." NO MEDICAL INTERVENTION REQUIRED. NO PATIENT INJURY OR CONSEQUENCE. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18730746 ↗
• MalfunctionFeb 15, 2024Material Twisted/Bent; Physical Resistance/Sticking; Material Twisted/Bent; Physical Resistance/Sticking

  IT WAS REPORTED THAT: DURING PICC INSERTION, INSERTER MET RESISTANCE AROUND 25 CM OF CATHETER INSERTED. MANOEUVRING TECHNIQUES WERE USED TO ADVANCE THE PICC UNSUCCESSFULLY. THE STYLET WIRE WAS ATTEMPTED TO BE REMOVED AND RESISTANCE MET. WIRE WAS FULLY RETRIEVED AND NOTED TO BE BENT AROUND 3 CM. STYLET WIRE EXCHANGED WITH NEW ACCESSORY WIRE AND PICC UNABLE TO BE ADVANCED. INSERTER THEN TRIED TO REMOVE PICC AND WAS UNABLE REMOVE. PICC COULD NOT BE FLUSHED HOWEVER WIRE COULD BE REMOVED. AS THE PEEL AWAY SHEATH WAS BROKEN AND REMOVED THE PICC CATHETER FINALLY GAVE WAY AND COULD BE REMOVED. CATHETER, STYLET, INTRODUCER ALL SAVED FOR REVIEW. THERE WAS A NOTICEABLE BEND IN THE CATHETER AROUND 8CM MARK. ASSOCIATED COMPLAINTS 9680794-2024-00092 AND 9680794-2024-00155.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18710058 ↗
• MalfunctionFeb 9, 2024Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED "DURING PICC INSERTION, INSERTER MET RESISTANCE 25 CM OF CATHETER INSERTED. THE STYLET WIRE WAS ATTEMPTED TO BE REMOVED AND RESISTANCE MET. WIRE WAS FULLY RETRIEVED AND NOTED TO BE BENT". THE WIRE WAS REMOVED AND NEW WIRE WAS USED. NO PATIENT HARM OR INJURY. NO MEDICAL INTERVENTION REQUIRED. PATIENT CONDITION REPORTED AS "FINE". ASSOCIATED MDR NUMBER 9680794-2024-00155.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18681315 ↗