ARROW IPN033362 (REF PR-05052-HP)Recalls & reported problems

Summary

The FDA's MAUDE database contains 48 adverse event reports that list this exact device (DI 10801902095388), received between Jun 4, 2021 and Sep 30, 2026 — classified as 4 injuries, 44 malfunctions.

The most frequently reported specific device problem is “Obstruction of Flow” (13 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 48 reports, in the reporter's own words as published by the FDA.

• InjurySep 30, 2026Separation Failure

  Patient problems: Insufficient Information

  MAUDE report 50949892 ↗
• MalfunctionSep 23, 2026Deformation Due to Compressive Stress

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50871044 ↗
• MalfunctionSep 23, 2026Deformation Due to Compressive Stress

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50870933 ↗
• MalfunctionSep 17, 2026Material Rupture

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50809230 ↗
• MalfunctionSep 16, 2026Deformation Due to Compressive Stress; Physical Resistance/Sticking

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50782577 ↗
• MalfunctionSep 16, 2026Deformation Due to Compressive Stress; Physical Resistance/Sticking

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50782450 ↗
• MalfunctionSep 16, 2026Deformation Due to Compressive Stress; Physical Resistance/Sticking

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50782449 ↗
• MalfunctionAug 12, 2026Obstruction of Flow

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50227775 ↗
• MalfunctionMay 26, 2026Deformation Due to Compressive Stress

  IT WAS REPORTED THAT DURING INITIAL INSERTION OF A PERIPHERALLY INSERTED CENTRAL CATHETER (PICC), RESISTANCE WAS ENCOUNTERED WHILE ADVANCING THE DILATOR AND PEEL-AWAY SHEATH FOLLOWING SKIN DILATION. THE DILATOR AND PEEL-AWAY SHEATH WERE REMOVED, AND A DEFORMITY OF THE SHEATH WAS OBSERVED. THE PROCEDURE WAS SUBSEQUENTLY COMPLETED WITHOUT COMPLICATIONS. THERE WERE NO REPORTS OF PATIENT INJURY, HARM, OR ADVERSE HEALTH CONSEQUENCES ASSOCIATED WITH THIS EVENT. THE PATIENT'S CONDITION WAS REPORTED AS "FINE." NO ADDITIONAL MEDICAL INTERVENTION WAS REQUIRED BEYOND REMOVAL OF THE AFFECTED DEVICES. GOOD FAITH EFFORTS WERE MADE TO OBTAIN ADDITIONAL INFORMATION REGARDING THE REPORTED DEVICE ISSUE; HOWEVER, NO FURTHER DETAILS WERE RECEIVED FROM THE USER FACILITY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25279823 ↗
• InjuryMay 26, 2026Material Separation; Deformation Due to Compressive Stress

  IT WAS REPORTED THAT DURING INITIAL INSERTION OF A PERIPHERALLY INSERTED CENTRAL CATHETER (PICC), RESISTANCE WAS ENCOUNTERED WHILE ADVANCING THE DILATOR AND PEEL-AWAY SHEATH DESPITE A DERMOTOMY HAVING BEEN PERFORMED. THE DILATOR AND SHEATH WERE SUBSEQUENTLY REMOVED, AND A MICROFRACTURE AT THE DILATOR AND SHEATH TIPS WERE OBSERVED. THE DEVICE WAS REPLACED. NO MEDICAL INTERVENTION WAS REQUIRED AS A RESULT OF THIS EVENT. THERE WERE NO REPORTS OF PATIENT INJURY, HARM, OR ADVERSE HEALTH CONSEQUENCES DUE TO THIS EVENT. THE PATIENT'S CONDITION WAS REPORTED AS "FINE." ASSOCIATED MDRS INCLUDE 9680794-2026-00415 AND .

  Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

  MAUDE report 25279512 ↗
• MalfunctionMay 26, 2026Material Separation; Deformation Due to Compressive Stress

  IT WAS REPORTED THAT DURING INITIAL INSERTION OF A PERIPHERALLY INSERTED CENTRAL CATHETER (PICC), RESISTANCE WAS ENCOUNTERED WHILE ADVANCING THE DILATOR AND PEEL-AWAY SHEATH DESPITE A DERMOTOMY HAVING BEEN PERFORMED. THE DILATOR AND SHEATH WERE SUBSEQUENTLY REMOVED, AND A MICROFRACTURE AT THE DILATOR AND SHEATH TIPS WERE OBSERVED. THE DEVICE WAS REPLACED. NO MEDICAL INTERVENTION WAS REQUIRED AS A RESULT OF THIS EVENT. THERE WERE NO REPORTS OF PATIENT INJURY, HARM, OR ADVERSE HEALTH CONSEQUENCES DUE TO THIS EVENT. THE PATIENT'S CONDITION WAS REPORTED AS "FINE." ASSOCIATED MDRS INCLUDE 9680794-2026-00415 AND 9680794-2026-00416.

  Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

  MAUDE report 25279085 ↗
• MalfunctionMay 14, 2026Obstruction of Flow; Material Protrusion/Extrusion

  IT WAS REPORTED THAT ON (B)(6) 2026, THE INFUSION PUMP GENERATED AN OCCLUSION ALARM. UPON CLINICAL ASSESSMENT OF THE PATIENT, A LUMP-LIKE SWELLING WAS OBSERVED UNDER THE SKIN ALONG THE CATHETER TRACT. APPROXIMATELY 10 CM OF THE CATHETER WAS REMOVED, AT WHICH TIME DEFORMITIES WERE NOTED IN TWO AREAS OF THE CATHETER. THE PERIPHERALLY INSERTED CENTRAL CATHETER (PICC) HAD BEEN INSERTED THREE DAYS PRIOR TO THE EVENT. THERE WERE NO REPORTS OF PATIENT INJURY, HARM, OR ADVERSE HEALTH CONSEQUENCES ASSOCIATED WITH THIS EVENT. NO ADDITIONAL MEDICAL INTERVENTION WAS REQUIRED BEYOND REMOVAL OF THE AFFECTED DEVICE AND REPLACEMENT WITH ANOTHER DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25175761 ↗
• MalfunctionMay 4, 2026Deformation Due to Compressive Stress; Premature Separation

  IT WAS REPORTED, "DURING THE PICC INSERTION PROCEDURE GUIDED BY ULTRASOUND, FOLLOWING SUCCESSFUL PUNCTURE WITH A 21G NEEDLE AND ULTRASOUND VERIFICATION OF INTRAVASCULAR GUIDE PLACEMENT, THE DILATOR WAS ADVANCED AND THEN THE PEEL-AWAY INTRODUCER WAS INSERTED. AT THE MOMENT OF ITS ADVANCEMENT, BLOOD WAS OBSERVED EXITING THROUGH THE UPPER JUNCTION BETWEEN THE PEEL-AWAY AND THE INTRODUCER, ACCOMPANIED BY ABNORMAL RESISTANCE AND A SENSATION OF TISSUE TEARING. THE DEVICE WAS IMMEDIATELY REMOVED, REVEALING STRUCTURAL DEFORMITY OF THE PEEL-AWAY (ABNORMAL) BLOOMING/OPENING OF THE MATERIAL). THE KIT WAS REPLACED AND THE PROCEDURE CONTINUED; THE PEEL-AWAY ADVANCED WITHOUT COMPLICATIONS AND THE CATHETER WAS THEN INSERTED. THE FOLLOWING ACTIONS WERE TAKEN: IMMEDIATE SUSPENSION OF THE PROCEDURE UPON EVIDENCE OF FAILURE, REMOVAL OF THE DEFECTIVE DEVICE, REQUEST FOR A NEW STERILE KIT, AND CATHETER INSERTION ACCORDING TO PROTOCOL. NO SIGNIFICANT INJURY WAS OBSERVED IN THE PATIENT. DURING THE EVENT, ABNORMAL RESISTANCE AND A SENSATION OF TISSUE TEARING WERE PERCEIVED; HOWEVER, THERE WAS NO SUBSEQUENT CLINICAL EVIDENCE OF RELEVANT VASCULAR OR TISSUE DAMAGE." THE PATIENT'S CONDITION WAS REPORTED AS FI

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25069722 ↗
• MalfunctionApr 28, 2026Material Twisted/Bent

  IT WAS REPORTED THAT, "THE INCIDENT OCCURRED DURING THE PROCEDURE. THE DOCTOR OPENED THE KIT AND PROCEEDED TO PERFORM THE PUNCTURE WITH THE INTRODUCER NEEDLE, BUT WHEN HE WENT TO USE THE DILATOR, HE NOTICED THAT THE DETACHABLE DILATOR AND THE TIP OF THE SHEATH WERE BENT. THE PROCEDURE HAD TO BE PERFORMED AGAIN, WHICH REQUIRED A SECOND PUNCTURE OF THE PATIENT." THE PATIENT'S CONDITION WAS REPORTED AS "FINE". IT WAS REPORTED THAT THE SECOND ATTEMPT WAS SUCCESSFUL. ADDITIONAL QUESTIONS WERE REQUESTED REGARDING WHETHER THERE WERE ANY PATIENT HARM, INJURY OR CONSEQUENCES, HOWEVER, FURTHER DETAILS WERE NOT PROVIDED AT THIS TIME. ASSOCIATED MDRS: 9680794-2026-00327.

  Patient problems: Insufficient Information

  MAUDE report 25023856 ↗
• MalfunctionApr 28, 2026Material Twisted/Bent

  IT WAS REPORTED THAT, "THE INCIDENT OCCURRED DURING THE PROCEDURE. THE DOCTOR OPENED THE KIT AND PROCEEDED TO PERFORM THE PUNCTURE WITH THE INTRODUCER NEEDLE, BUT WHEN HE WENT TO USE THE DILATOR, HE NOTICED THAT THE DETACHABLE DILATOR AND THE TIP OF THE SHEATH WERE BENT. THE PROCEDURE HAD TO BE PERFORMED AGAIN, WHICH REQUIRED A SECOND PUNCTURE OF THE PATIENT." THE PATIENT'S CONDITION WAS REPORTED AS "FINE". IT WAS REPORTED THAT THE SECOND ATTEMPT WAS SUCCESSFUL. ADDITIONAL QUESTIONS WERE REQUESTED REGARDING WHETHER THERE WERE ANY PATIENT HARM, INJURY OR CONSEQUENCES, HOWEVER, FURTHER DETAILS WERE NOT PROVIDED AT THIS TIME. ASSOCIATED MDRS: 9680794-2026-00339.

  Patient problems: Insufficient Information

  MAUDE report 25023801 ↗
• MalfunctionApr 14, 2026Obstruction of Flow

  IT WAS REPORTED "PATIENT REQUIRING A VENOUS ACCESS CATHETER PERIPHERAL CENTRAL LINE FOR ADMINISTRATION OF VESICANT AND IRRITANT MEDICATIONS, THE SHIFT LEADER PERFORMS THE PROCEDURE, THE CATHETER DOES NOT ADVANCE TO THE IDEAL LOCATION, ONE LINE REMAINS WITHOUT FLOW AND THE OTHER WITH SLOW FLOW; BY THE SECOND DAY, NONE OF THE LINES HAD SUFFICIENT FLOW FOR LABORATORY SAMPLING AND NEEDED TO BE PUNCTURED; ALSO, ONE OF THE LINES DID NOT HAVE SUFFICIENT FLOW FOR HIGH-FLOW INFUSIONS." 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 24872180 ↗
• MalfunctionMar 30, 2026Material Twisted/Bent

  IT WAS REPORTED "THE GUIDE BENDS WHEN INSERTED". 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 24729501 ↗
• MalfunctionJan 29, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT "PATIENT WITH VASCULAR ACCESS VIA A DOUBLE-LUMEN PICC CATHETER INSERTED ON (B)(6) 2025, IN THE RIGHT UPPER LIMB, AND REMOVED ON (B)(6) 2025, DUE TO EXTERNAL LEAKAGE OF INTRAVENOUS FLUIDS ADMINISTERED, VISIBLE IN BOTH LUMENS." 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 24209142 ↗
• MalfunctionDec 23, 2025Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED THAT "THE WHITE LINE OF THE LINE WAS BLOCKED AT THE Y-JUNCTION, PREVENTING EVEN THE GUIDE WIRE FROM PASSING THROUGH. THIS SITUATION AROSE DURING THE PROCEDURE, NECESSITATING THE INSERTION OF ANOTHER LINE". THERE WAS NO PATIENT HARM OR INJURY. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "DISCHARGED FROM THE CLINIC".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23876564 ↗
• MalfunctionDec 9, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT "ONCE INSERTED, THE PICC CATHETER SHOWS LEAKAGE THROUGH THE DISTAL LUMEN, DESPITE BEING FLUSHED BEFORE INSERTION INTO THE PATIENT." THE DEVICE WAS REPLACED. THERE WAS NO PATIENT HARM OR INJURY. NO MEDICAL INTERVENTION REQUIRED. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "PROGESSING WELL AND BEING DISCHARGED".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23757170 ↗
• InjuryNov 21, 2025Patient-Device Incompatibility; Adverse Event Without Identified Device or Use Problem; Patient-Device Incompatibility; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT "THE PATIENT PRESENTED WITH HARDENING, WARMTH, AND REDNESS ALONG THE TRACT OF A PICC LINE IN THE SUPERIOR CEPHALIC VEIN OF THE RIGHT UPPER EXTREMITY. THE CATHETER WAS INSERTED ON (B)(6) 2025. THE DEVICE WAS REMOVED". THERE WAS NO MEDICAL INTERVENTION REQUIRED. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE".

  Patient problems: Skin Inflammation/ Irritation

  MAUDE report 23623903 ↗
• MalfunctionNov 14, 2025Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED "THE HEAD PERFORMS THE PUNCTURE AND INSERTS THE GUIDE, BUT OBSTRUCTION IS PRESENT DESPITE RAISING THE ARM AND REMOVING THE TOURNIQUET. THE GUIDE IS REMOVED AND FOUND TO BE BENT, THEREFORE, INSERTION IS PERFORMED IN THE ANTECUBITAL AREA OF THE MSD, THE PUNCTURE IS SUCCESSFUL, AN ACCESSORY GUIDE IS INSERTED, AND WHEN THE GUIDE IS RETURNED, NO OUTLET IS OBTAINED THROUGH THE PICC LUMEN, SO THE PICC IS RETURNED AND THE INTENSIVE CARE PHYSICIAN IS NOTIFIED FOR CVC. AN ADVERSE EVENT IS REPORTED." THERE WAS NO PATIENT HARM OR INJURY. NO MEDICAL INTERVENTION REQUIRED. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE". ASSOCIATED MDR NUMBERS INCLUDE: 9680794-2025-00936 AND 9680794-2025-00930

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23555839 ↗
• MalfunctionNov 14, 2025Obstruction of Flow; Material Twisted/Bent; Obstruction of Flow; Material Twisted/Bent

  IT WAS REPORTED THAT "THE HEAD PERFORMS THE PUNCTURE AND INSERTS THE GUIDE, BUT OBSTRUCTION IS PRESENT DESPITE RAISING THE ARM AND REMOVING THE TOURNIQUET. THE GUIDE IS REMOVED AND FOUND TO BE BENT, THEREFORE, INSERTION IS PERFORMED IN THE ANTECUBITAL AREA OF THE MSD, THE PUNCTURE IS SUCCESSFUL, AN ACCESSORY GUIDE IS INSERTED, AND WHEN THE GUIDE IS RETURNED, NO OUTLET IS OBTAINED THROUGH THE PICC LUMEN, SO THE PICC IS RETURNED AND THE INTENSIVE CARE PHYSICIAN IS NOTIFIED FOR CVC." THERE WAS NO PATIENT HARM OR INJURY. NO MEDICAL INTERVENTION REQUIRED. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE". ASSOCIATED MDR NUMBERS INCLUDE: 9680794-2025-00936 AND 9680794-2025-00930.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23555011 ↗
• MalfunctionNov 4, 2025Obstruction of Flow; Material Deformation; Obstruction of Flow; Material Deformation

  IT WAS REPORTED THAT "THE CATHETER IS EXAMINED, AND A SMALL NOTCH IS OBSERVED, SO A TEST WITH SALINE SOLUTION IS PERFORMED, WITH ADEQUATE FLOW THROUGH BOTH LUMENS. ACCORDING TO PR-CME-20, A SINGLE PUNCTURE IS MADE IN THE LEFT CEPHALIC VEIN USING THE DIRECT PUNCTURE TECHNIQUE, ADVANCING WITH LITTLE DIFFICULTY THROUGH THE DILATOR. AFTER ADVANCING THE DILATOR, THERE IS NO PROBLEM, AND ONCE INSIDE THE VESSEL, IT ADVANCES 40 CM. AN ATTEMPT TO FLUSH THE LUMENS IS UNSUCCESSFUL, SO IT IS WITHDRAWN FROM THE VESSEL WITH SOME TURBULENCE. A NEW CATHETER IS REQUESTED, THROUGH THE SAME VEIN USING THE DILATOR, AND THE NEW CATHETER IS ADVANCED THE FULL 50 CM OF THE TOTAL LENGTH OF A DOUBLE-LUMEN CATHETER. IT IS PLACED TO DETERMINE THE POSITION OF THE TIP, OBTAINING GOOD VENOUS RETURN THROUGH THE LUMENS AND EASY FLOW OF FLUIDS." THERE WAS NO PATIENT CONSEQUENCES. NO MEDICAL INTERVENTION REQUIRED. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23466910 ↗
• MalfunctionAug 18, 2025Material Perforation; Material Perforation

  IT WAS REPORTED THAT "UPON REVIEWING THE PICC CATHETER AFTER IMPLANTATION, A PERFORATION WAS OBSERVED IN ONE OF ITS LUMENS, WITH THE GUIDEWIRE EXITING INTO THE MUSCLE TISSUE. FOR THIS REASON, THE CATHETER REQUIRES EMERGENCY REMOVAL AND THE IMPLANTATION OF A NEW DEVICE. NO IMMEDIATE COMPLICATIONS WERE REPORTED". 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 22826715 ↗

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