ARROW IPN033358Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 00801902095367), received between Mar 29, 2024 and Jul 31, 2025 — classified as 17 malfunctions.

The most frequently reported specific device problem is “Material Twisted/Bent” (8 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 18, 2026.

Most reported problems

Recent adverse event reports

The 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 31, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED "AT 20:40 HOURS, FOLLOWING APPROPRIATE ASEPTIC TECHNIQUE, PICC CATHETER INSERTION WAS INITIATED. HOWEVER, AFTER ADVA NCING THE GUIDEWIRE AND ATTEMPTING TO ADVANCE THE PEEL-AWAY SHEATH, THE SHEATH RUPTURED AT ITS PROXIMAL THIRD, WHICH PREVENTED FURTHER ADVANCEMENT." A REPLACEMENT CATHETER WAS USED SUCCESSFULLY. 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 22674675 ↗
• MalfunctionJul 29, 2025Unraveled Material; Unraveled Material

  IT WAS REPORTED "DURING THE PICC PLACEMENT PROCEDURE, THE GUIDEWIRE SHOWED A LOSS OF ITS ORIGINAL STRUCTURAL INTEGRITY, THEREFORE ANOTHER CATHETER WAS REQUESTED TO COMPLETE THE PROCEDURE." 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 22645147 ↗
• MalfunctionJun 4, 2025Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED "DURING THE PASSAGE OF THE PICC CATHETER IN THE PATIENT THE PROCEDURE IS PERFORMED WITHOUT COMPLICATIONS, HOWEVER WHEN THE EQUIPMENT IS WASHED AND TO MAKE A NEW BLOOD RETURN." 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 22143930 ↗
• MalfunctionMar 12, 2025Adhesive Too Strong; Adhesive Too Strong

  IT WAS REPORTED THAT A PATIENT WITH AN INDICATION FOR PICC ARROW 4.0 FR CATHETER PLACEMENT FOR POTASSIUM ADMINISTRATION EXPERIENCED DIFFICULTY DURING CATHETER PASSAGE. ADHESIONS WERE OBSERVED ON THE PROXIMAL PART OF THE CATHETER, PREVENTING ADVANCEMENT THROUGH THE DILATOR FOR INSERTION. THE PATIENT HAD NO HARM OR INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21584938 ↗
• MalfunctionFeb 10, 2025Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT "IN THE PICC CATHETER PLACEMENT PROCEDURE FOR A PEDIATRIC PATIENT, A PEDIATRIC SURGEON, PROCEEDS TO OPEN THE PACKAGING OF THE STERILE DEVICE, THEN TAKES THE INTRODUCER NEEDLE TO PUNCTURE THE PATIENT'S UPPER EXTREMITY IN THE BASILIC VEIN. HOWEVER, IT PRESENTED PROBLEMS ON THE INTRODUCTION AND RESISTANCE IN ENTRY; 3 ATTEMPTS ARE MADE, AND WHEN OBSERVING THE BEVEL ON THE PROMINENT TIP, A DEVIATION (BENT) IS OBSERVED; WHICH CAN CAUSE RESISTANCE WHEN THE NEEDLE ENTERS THE VENOUS CAPITAL". ADDITIONAL INFORMATION REPORTED THAT THE PATIENT WAS FINE AND THE DEVICE WAS REPLACED TO RESOLVE THE ISSUE.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 21344253 ↗
• MalfunctionNov 13, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED "I ASSUME THAT AFTER 2 DAYS OF INSERTING THE CATHETER, LEAKAGE IS OBSERVED BY THE NURSING STAFF." 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 20673769 ↗
• MalfunctionOct 29, 2024Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED "AT THE TIME OF INSERTION OF THE HYDROPHILIC GUIDE, IT IS SHOWN TO BE BENT, MAKING IT IMPOSSIBLE TO INSERTION OF THE DILATOR. ANOTHER CATHETER IS REQUESTED." THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20556690 ↗
• MalfunctionSep 19, 2024Break; Break

  IT WAS REPORTED THAT: "THE DILATOR BREAKS TRANSVERSALLY. UNABLE TO COMPLETE THE PROCEDURE WITH THIS DEVICE. ANOTHER DEVICE IS USED SUCCESSFULLY. THERE WAS NO REPORTED PATIENT HARM OR CONSEQUENCE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20255137 ↗
• MalfunctionAug 12, 2024Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT: "DURING THE PREPARATION AND OPENING OF THE SUPPLIES THE METALLIC GUIDEWIRE INSIDE THE PROTECTOR WAS FOUND TO BE BENT. THE REPORTED DEFECT WAS DETECTED PRIOR TO USE (IN A CLINICAL SETTING). THERE WAS NO PATIENT INVOLVEMENT."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19958642 ↗
• MalfunctionJul 12, 2024Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED "AFTER HAVING PASSED AND ADVANCED THE CATHETER WITHOUT COMPLICATIONS, A RADIOLOGICAL CONTROL (CHEST X-RAY) WAS PERFORMED, WHICH REPORTED A LEFT PICC BENT IN THE TOPOGRAPHY OF THE LEFT BRACHIOCEPHALIC VEIN, WITH THE DISTAL END IN A LATERAL DIRECTION AND THE LEFT SUBCLAVIAN VEIN, WHICH MADE IT DIFFICULT TO REPOSITION. THEREFORE, IT WAS DECIDED TO COMPLETELY REMOVE THE PICC DEVICE. THE ONCOLOGIST REQUESTED A NEW PROCEDURE BY INTERVENTIONAL RADIOLOGY." THERE WAS NO PATIENT HARM OR INJURY. THE PAITENT'S CURRENT CONDITION IS REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19730804 ↗
• MalfunctionJul 12, 2024Difficult to Advance; Difficult to Advance

  IT WAS REPORTED "A 4FR BILUMEN PICC CATHETER INSERTION PROCEDURE IS PERFORMED THROUGH THE BASILIC VEIN IN THE LEFT UPPER LIMB BY THE HEAD NURSE IN THE INTENSIVE CARE UNIT AND UNDER ULTRASOUND GUIDANCE FOR VASCULAR ACCESS. AT THE TIME OF INSERTING THE CATHETER, IT IS DIFFICULT TO ADVANCE, AND AS THE CATHETER IS ADVANCED, IT BECOMES MORE FLEXIBLE, HOWEVER, IT CAN BE ACCOMMODATED IN A RETRY." 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 19730168 ↗
• MalfunctionJul 12, 2024Difficult to Advance; Material Twisted/Bent; Difficult to Advance; Material Twisted/Bent

  IT WAS REPORTED THAT: "THE PATIENT HAD A RIGHT SUBCLAVIAN IMPLANTABLE CATHETER, SO A 4FR BILUMEN PICC CATHETER WAS INSERTED THROUGH THE BASILIC VEIN IN THE LEFT UPPER LIMB BY THE HEAD NURSE IN THE INTENSIVE CARE UNIT AND UNDER ULTRASOUND GUIDANCE FOR VASCULAR ACCESS. DURING THE PASSAGE OF THE CATHETER, IT DID NOT ADVANCE MORE THAN 25 CM, WHICH CAUSED IT TO COLLIDE WITH THE IMPLANTABLE CATHETER. THREE ATTEMPTS WERE MADE TO REPOSITION THE CATHETER; HOWEVER, THIS WAS UNSUCCESSFUL AND IT WAS DECIDED TO COMPLETELY REMOVE THE DEVICE." ADDITIONAL INFORMATION: "THERE WAS NO KINK IN THE GUIDE WIRE, THE ISSUE WAS WITH THE CATHETER." THERE WAS NO REPORTED PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19728315 ↗
• MalfunctionJul 11, 2024Difficult to Advance; Material Twisted/Bent; Difficult to Advance; Material Twisted/Bent

  IT WAS REPORTED "A NEW 4.0 FR BI-LUMEN PICC CATHETER WAS INSERTED INTO THE BRACHIAL VEIN OF THE RIGHT UPPER LIMB. THE PROCESS WAS CARRIED OUT BY THE HEAD NURSE IN THE INTENSIVE CARE UNIT AND UNDER ULTRASOUND GUIDANCE FOR VASCULAR ACCESS. DURING THE PASSAGE OF THE CATHETER, THERE WAS DIFFICULTY IN ADVANCING THE COURSE OF THE VESSEL, WHICH AT THE TIME WAS SUSPECTED OF INTERFERENCE WITH THE IMPLANTABLE CATHETER, SO IT WAS REVIEWED WITH A CHEST X-RAY WHERE THE CATHETER WAS OBSERVED COILED AT THE RIGHT SUBCLAVIAN LEVEL, SO IT WAS DECIDED TO REMOVE THE CATHETER COMPLETELY. PICC INSERTION WAS THEN REQUESTED BY RADIOLOGY, SINCE THE LEFT LIMB WAS NOT ACCESSIBLE DUE TO SIGNS OF INFECTION." 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 19720455 ↗
• MalfunctionJul 11, 2024Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED "THE FIRST INSERTION IS MADE IN THE BASILIC VEIN OF THE UPPER LEFT LIMB. DURING THE PASSAGE OF THE CATHETER, IT IS OBSERVED THAT IT REMAINS ASCENDING, SO IT IS REPOSITIONED AND IN THIS ATTEMPT IT IS ROLLED UP AT THE LEVEL OF THE RIGHT SUBCLAVIAN, OBSERVED BY MEANS OF RADIOLOGICAL CONTROL TO DETERMINE POSITION, SO THE DEVICE IS COMPLETELY REMOVED. THE PICC INSERTION IS CARRIED OUT IN A SECOND ATTEMPTTHAT WAS SUCCESSFUL, WITH A NEW DEVICE." 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 19720242 ↗
• MalfunctionApr 8, 2024Material Too Rigid or Stiff; Material Twisted/Bent; Material Too Rigid or Stiff; Material Twisted/Bent

  IT WAS REPORTED, "DURING THE TECHNIQUE, THERE WAS DIFFICULTY DURING THE PROGRESS OF THE CATHETER TO ACCESS THE VENOUS ACCESS DUE TO ITS KINKING. NURSING AREA WITH EXPERIENCE AND IN CHARGE OF PICC CATHETER INSERTION INDICATES THAT THE MAIN DIFFICULTY IS ASSOCIATED WITH THE CALIBER OF THE CATHETER, SINCE IT IS NOT VERY RIGID AND THIS LEADS TO ITS KINKING". 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 19058697 ↗
• MalfunctionApr 1, 2024Difficult to Advance; Difficult to Advance

  IT WAS REPORTED "THE PICC CATHETER INSERTION PROCEDURE BEGAN THROUGH THE PERIPHERAL ROUTE UNDER ULTRASOUND GUIDANCE, HOWEVER, AFTER HAVING VENOUS ACCESS WITH THE CATHETER INTRODUCER , IT IS EVIDENT THAT THE BILUMEN CATHETER DOES NOT ADVANCE, DESPITE THE FACT THAT THE METAL GUIDE DOES PASS WITHOUT DIFFICULTY." A NEW CATHETER WAS USED. NO MEDICAL INTERVENTION REQUIRED. NO PATIENT HARM OR INJURY. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE"

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19015498 ↗
• MalfunctionMar 29, 2024Material Deformation; Material Deformation

  THE REPORT STATES THAT "THE HEAD OF NURSING REPORTS THAT WHEN INSERTING THE INTRODUCER AND PASSING THE GUIDE, IT DOES NOT REVEAL A HOLE IN THE DEVICE, FOR THIS REASON THE DEVICE IS NOT USED". NO PATIENT HARM OR INJURY. THE PATIENT STATUS IS REPORTED AS "FINE". AT THE TIME OF THIS REPORT, THE CUSTOMER HAS NOT RETURNED OUR REQUESTS FOR ADDITIONAL INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19005810 ↗

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