ARROW IPN033424Recalls & reported problems

Summary

The FDA's MAUDE database contains 70 adverse event reports that list this exact device (DI 00801902101099), received between Aug 31, 2023 and Feb 24, 2026 — classified as 70 malfunctions.

The most frequently reported specific device problem is “Break” (23 reports).

6 other recalls cover devices cleared under the same FDA submission (K113277); 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 70 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 24, 2026Material Puncture/Hole

  IT WAS REPORTED "PICC INSERTED ON (B)(6) 2025. WHILST STILL IN PATIENT IT WAS DISCOVERED THAT THERE WAS A HOLE/ FRACTURE NEAR THE HUB." THE DEVICE WAS REMOVED AND REPLACED WITH A NEW ONE. 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 24428640 ↗
• MalfunctionFeb 9, 2026Material Split, Cut or Torn

  IT WAS REPORTED THAT "OPERATING ROOM REPORTED A DAMAGED/TORN RUBBER TIP, FAILED TO INSERT DURING USE." 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 24293355 ↗
• MalfunctionDec 11, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED "PICC LUMEN SPLIT INTERNALLY IN PATIENT". THE PATIENT HAD EXTRAVASATION IN THEIR UPPER ARM. THERE WAS NO MEDICAL INTERVENTION REQUIRED. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE".

  Patient problems: Extravasation

  MAUDE report 23777124 ↗
• MalfunctionDec 2, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT "PICC LINE RUPTURED AFTER 14 DAYS OF INSERTION. ONLY USED FOR INFUSING DRUGS FOR THESE DAYS AND NOT USED FOR PRESSURE INJECTABLES." THE RUPTURED CATHETER WAS CAUTIOUSLY AND THOROUGHLY REMOVED FROM THE PATIENT'S BODY, ENSURING THAT NO PORTION REMAINED INSIDE. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "CRITICAL".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23693030 ↗
• MalfunctionNov 3, 2025Break; Break

  IT WAS REPORTED THAT "THE LUER-HUB (WHITE) BROKEN." THE DEVICE WAS REMOVED AND REPLACED. 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 23452116 ↗
• MalfunctionOct 20, 2025Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED "SWG KINKING". THE USER CHANGED TO A NEW SET TO RESOLVE THE ISSUE. THERE WAS NO MEDICAL INTERVENTION REQUIRED. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23336989 ↗
• MalfunctionOct 20, 2025Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED "SWG KINKING". THE USER CHANGED TO A NEW SET TO RESOLVE THE ISSUE. THERE WAS NO MEDICAL INTERVENITON REQUIRED. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23334989 ↗
• MalfunctionOct 8, 2025Improper Flow or Infusion; Improper Flow or Infusion

  IT WAS REPORTED "RN NOTICED BLOOD REFLUXING INTO WHITE (PROXIMAL) LUMEN WHEN ASPIRATING AND FLUSHING PINK (DISTAL) LUMEN. CALLED INFUSION THERAPY FOR REVIEW. WE FOUND THE SAME WHEN ASPIRATING AND FLUSHING SUSPECTED SEPTUM RUPTURE SO INITIATED PICC REMOVAL." THE PATIENT'S CURRENT CONDITION IS REPORTED AS "DECEASED". THE DEVICE WAS NOT CONTRIBUTORY TO THE PATIENT'S CAUSE OF DEATH.

  Patient problems: Insufficient Information

  MAUDE report 23245122 ↗
• MalfunctionSep 16, 2025Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT "GUILD WIRED KINKING". THE DEVICE WAS REMOVED AND REPLACED. 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 23062799 ↗
• MalfunctionSep 16, 2025Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT "GUILD WIRED KINKING". THE DEVICE WAS REMOVED AND REPLACED. 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 23062764 ↗
• MalfunctionSep 10, 2025Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT "THE HCP IDENTIFIED THAT WIRE GOT KINKED DURING THE PROCEDURE AND DOCTOR USED ANOTHER NEW ARROW PICC AND ITS WORKS FINE COMPLETED THE CASE 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 23017790 ↗
• MalfunctionAug 18, 2025Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED "PICC INSERTED IN ICU ON (B)(6) 2025 FOR IV ANTIBIOTICS. BLOCKED AND UNBLOCKED BY INTENSIVIST ON (B)(6). BLOCKED AND REMOVED ON (B)(6) 2025.". 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 22827067 ↗
• MalfunctionAug 18, 2025Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED "PICC INSERTED IN ICU ON (B)(6) 2025 FOR IV INOTROPES. BLOCKED AND REMOVED ON (B)(6) 2025." 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 22827026 ↗
• MalfunctionAug 18, 2025Complete Blockage; Complete Blockage

  IT WAS REPORTED "PICC INSERTED IN ICU ON (B)(6) 2025 FOR IV ANTIBIOTICS. BLOCKED ON (B)(6) 2025. " ADDITIONALLY, "THE SITE AS A WHOLE HAS NOTICED AN INCREASE IN BLOCKED PICCS OVER THE LAST FEW MONTHS." THERE WAS NO PATIENT HARM OR INJURY. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE". ASSOCIATED MDR NUMBERS INCLUDE: 9680794-2025-00691 AND 9680794-2025-00690.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22826798 ↗
• MalfunctionAug 6, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED "SPLIT IN LINE CAUSING LEAKING, POTENTIALLY FROM WEAR FROM SLIDE CLAMP CAUSING CUT." THERE WAS NO MEDICAL INTERVENTION REQUIRED. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "DECEASED". IT WAS REPORTED "MEDICAL STAFF ADVISED PICC LEAKING DID NOT CONTRIBUTE TO DEATH."

  Patient problems: Insufficient Information

  MAUDE report 22727895 ↗
• MalfunctionJul 9, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED "SHEATH SPLIT IN TWO AND BROKE ON INSERTION. PATIENT NOT AFFECTED. USER STATES THAT THIS HAS HAPPENED BEFORE." THE DEVICE WAS REPLACED. 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 22457270 ↗
• MalfunctionJun 17, 2025Material Separation; Material Separation

  IT WAS REPORTED "DURING A PICC PROCEDURE IN THE CENTRAL OPERATING ROOM, IT WAS FOUND THAT THE INSERTION PART OF THE PEEL-AWAY INTRODUCER WAS SEPARATED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING A NEW PRODUCT." THERE WAS NO MEDICAL INTERVENTION REQUIRED. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22236344 ↗
• MalfunctionMay 28, 2025Entrapment of Device; Entrapment of Device

  IT WAS REPORTED "PICC INSERTION BY PICC NURSE IN THEATRE. WIRE BECAME STUCK IN PATIENT VESSEL AND WAS NOT ABLE TO REMOVE. THEY CONTACTED VASCULAR TEAM WHO REMOVED THE WIRE. VASCULAR TEAM FELT THAT THE WIRE WAS STUCK DUE TO PRODUCT FAULT NOT TO DO WITH PATIENT VESSELS ETC. CUSTOMER FEELS THAT THERE IS SOMETHING WRONG WITH THE WIRE EXPLAINED IT FELT ROUGH." ADDITIONAL INFORMATION RECEIVED REPORTS " THE VASCULAR REG HAD THE WIRE ON ULTRASOUND IMAGE, IDENTIFIED THE POSITION OF THE TIP, THEN USED A FLICKING TECHNIQUE AND PULLED OUT THE REMAINING WIRE, AS PER THE VASCULAR REG A TECHNIQUE THEY USE TO DISLODGE A WIRE." THERE WAS NO PATIENT SIGNS OR SYMPTOMS. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "STABLE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22095256 ↗
• MalfunctionMay 15, 2025Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED "DOCTOR AND STAFF HAVE NOTICED FREQUENT PICC BLOCKAGES OVER A 4-6-MONTH PERIOD. THIS IS THE FIRST OFFICIAL REPORT WE HAVE RECEIVED. IT HAS BEEN NOTICED BY STAFF MEMBERS AT THE CRITICAL CARE UNIT." THERE WAS NO PATIENT HARM OR INJURY. THE PATIENT'S CURRENT CONDITION IS REPORTED AS STABLE. ASSOCIATED MDR NUMBERS INCLUDE: 9680794-2025-00418, 9680794-2025-00422, 9680794-2025-00456, 9680794-2025-00457, 9680794-2025-00458, 9680794-2025-00459, 9680794-2025-00460, 9680794-2025-00461, 9680794-2025-00462.

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

  MAUDE report 22029341 ↗
• MalfunctionMay 14, 2025Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED "WHEN THE PRODUCT WAS OPENED FOR THE PICC PROCEDURE IN THE ANGIOGRAPHY ROOM, IT WAS FOUND THAT THE WIRE IS BENT. IT WAS REPLACED WITH THE NEW PRODUCT." THIS WAS FOUND PRIOR TO USE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22018596 ↗
• MalfunctionMay 9, 2025Break; Break

  IT WAS REPORTED "THE PEEL-AWAY SHEATH BROKE OFF INSIDE THE PATIENT (HAS BEEN REMOVED). THE PATIENT IS SAFE." THE USER CHANGED TO A NEW SET. THERE WAS NO PATIENT HARM OR INJURY. NO MEDICAL INTERVENTION REQUIRED. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE".

  Patient problems: Foreign Body In Patient

  MAUDE report 21993920 ↗
• MalfunctionFeb 5, 2025Difficult or Delayed Separation; Difficult or Delayed Separation

  IT WAS REPORTED THAT A RADIOLOGIST STRUGGLED TO USE THE PEEL AWAY SHEATH AND HAD TO PULL HARD TO GET IT OUT OF PATIENT. THE DEVICE WAS REMOVED IN ITS ENTIRETY. THE PATIENT WAS FINE AND HAD NO HARM OR INJURY. THE SAME PICC WAS LATER PLACED SUCCESSFULLY. THE ASSOCIATED EMDR REPORT NUMBERS ARE 9680794-2025-00009 AND 9680794-2025-00099.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21314063 ↗
• MalfunctionJan 3, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT "WHEN THE RADIOLOGIST ATTEMPTED TO PEEL THE PEEL-AWAY SHEATH, THE PLASTIC MATERIAL TORE, LEAVING A PORTION OF IT INSIDE THE PATIENT. THE RADIOLOGIST WAS ABLE TO RETRIEVE THE REMAINING PIECE USING FORCEPS IMMEDIATELY". AFTER THE SHEATH WAS REMOVED WITH FORCEPS, THE PICC LINE WAS PLACED SUCCESSFULLY. THE PATIENT HAD NO HARM OR HEALTH CONSEQUENCES FROM THIS INCIDENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21067499 ↗
• MalfunctionDec 10, 2024Material Too Rigid or Stiff; No Flow; Material Too Rigid or Stiff; No Flow

  IT WAS REPORTED THAT "THE PRODUCT WAS OPENED AND USED FOR A PATIENT. AFTER APPROXIMATELY ONE WEEK OF USE, THE CATHETER TIP BECAME RIGID (RED TIP) NEAR THE CENTRAL VENOUS END, AND THE CATHETER WALL DID NOT REBOUND AS EXPECTED. THIS CAUSED AN INABILITY TO ADMINISTER MEDICATIONS THROUGH THE CATHETER. THE CATHETER COULD ONLY BE USED AGAIN AFTER A WAITING PERIOD, ONCE THE REBOUND OCCURRED". THE USER CHANGED TO A NEW CATHETER. 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 20894398 ↗
• MalfunctionNov 25, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT "ONE WING BROKE OFF, WITH ALL BUT APPROX 1 CM REMAINING IN PATIENT'S ARM. THE NURSE REQUIRED 2 ARTERY FORCEPS TO GRIP REMAINING SHEATH TO SLOWLY RETRACT FROM PATIENTS ARM, THEN SLIDE UP PICC TO HUB WHERE IT STARTED TO SEPARATE AND REMOVE FROM PICC LINE." THE SHEATH WAS COMPLETELY REMOVED. THERE WAS NO PATIENT HARM OR INJURY. NO MEDICAL INTERVENTION REQUIRED. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE".

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

  MAUDE report 20771588 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K113277. 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-1254-2020 · Dec 20, 2019 · Terminated
  PICC Set- PR-35052-HPHNM
• Z-2023-2018 · Apr 11, 2018 · Terminated
  ARROW PICC Set; Product codes: PR-34052-HPHNM, PR-34063-HPHNM, PR-35041-HPHNM, PR-35052-HPHNM, PR-35541-HPHNL, PR-35541-HPHNM, PR-35552-HPHNL, PR-35552-HPHNM
• Z-0602-2018 · Jul 25, 2017 · Terminated
  ArrowADVANTAGE 5 Pressure Injectable Peripherally Inserted Central Catheter (PICC). Product Codes: PR-35041-HPHNM and CDA-35041-HPK1A.
• Z-0182-2018 · Jun 1, 2017 · Terminated
  ArrowADVANTAGE5" Pressure Injectable Peripherally Inserted Central Catheter (PICC) The Pressure Injectable PICC is indicated for short or long term peripheral access to the central
• Z-0207-2016 · Oct 16, 2015 · Terminated
  ARROW PICC Kit featuring Chlorag+ard Technology Midline Catheterization Kit ARROW Advantage5 Pressure Injectable PICC Kit Arrow Pressure Injectable Arrow PICC powered by Arrow VPS