ARROW IPN033412Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 00801902101051), received between Aug 31, 2023 and Mar 19, 2026 — classified as 15 malfunctions.

The most frequently reported specific device problem is “Material Twisted/Bent” (4 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. 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 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 19, 2026Material Twisted/Bent

  IT WAS REPORTED "DIFFICULT PICC INSERTION. INSERTION CEASED DUE TO INABILITY TO ADVANCE CATHETETER. ATTEMPTED REMOVAL UNSUCCESSFUL AS CATHETER 'LODGED' INSITU. XRAY ORDERED AND PICC VISUALISED AS BEING KNOTTED. PATIENT REFERRED FOR SURGICAL REVIEW. SURGICAL TEAM ALLEGEDLY PULLED ON THE CATHETER IN ATTEMPT TO REMOVE IT HOWEVER WERE UNSUCCESSFUL AND IN THE PROCESS SNAPPING THE CATHETER LEAVING SOME CATHETER INSITU. PATIENT WILL NOW BE TRANSPORTED TO TERTIARY HOSPITAL FOR VASCULAR INTERVENTION. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE". ASSOCIATE MDR NUMBERS INCLUDE: 9680794-2026-00204 AND 9680794-2026-00221.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24639263 ↗
• MalfunctionFeb 26, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED "WITHIN 5 DAYS PT PRESENTED WITH ARM SWELLING. CONFIRMATION VIA ULTRASOUND THAT PT DEVELOPED DVT. INSERTED BY RADIOLOGIST ON LEFT SIDE, UNKNOWN VESSEL. CAJ TIP PLACEMENT. 4 CM EXTERNAL LENGTH. FLUCLOXACILLIN INFUSED. PT STILL HAS LINE INSERTED." THE HEMATOLOGY DOCTOR WAS CALLED TO ADVISE FOR TREATMENT. THERE WAS NO PATIENT HARM OR INJURY. NO MEDICAL INTERVENTION REQUIRED. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE".

  Patient problems: Swelling/ Edema; Thrombosis/Thrombus

  MAUDE report 24454708 ↗
• MalfunctionFeb 26, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED "WITHIN 5 DAYS PT PRESENTED WITH ARM SWELLING . CONFIRMATION VIA ULTRASOUND THAT PT DEVELOPED DVT. INSERTED BY NURSE , LEFT BASILIC. 4.2MM VESSEL. UPPER SVC TIP PLACEMENT CONFIRMED VIA XRAY.2 CM EXTERNAL LENGTH. ONCOLOGY OUTPATIENT. NORMAL CHEMO DRUGS INFUSED. PT STILL HAS LINE INSERTED." THE HEMATOLOGY THROMBUS DOCTOR WAS CALLED TO ADVISE FOR TREATMENT. THERE WAS NO PATIENT HARM OR INJURY. NO MEDICAL INTERVENTION REQUIRED. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE".

  Patient problems: Thrombosis/Thrombus

  MAUDE report 24454654 ↗
• MalfunctionFeb 26, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED "WITHIN 5 DAYS PT PRESENTED WITH ARM SWELLING . CONFIRMATION VIA ULTRASOUND THAT PATIENT DEVELOPED DVT. INSERTED BY NURSE , LEFT BASILIC. 5.1MM VESSEL. LOWER SVC TIP PLACEMENT CONFIRMED VIA XRAY. 0 CM EXTERNAL LENGTH. PATIENT HAD PREVIOUS THROMBUS, BUT WAS ANTICOAGULATED WHEN PICC WAS INSERTED. MEROPENEM AND DAPTOMYCIN INFUSED. PT HAD OTHER DEVICE INSERTED ON 30/1/26." HEMATOLOGY THROMBUS TEAM WAS CALLED TO ADVISE FOR TREATMENT. THERE WAS NO PATIENT HARM OR INJURY. NO MEDICAL INTERVENTION REQUIRED. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE".

  Patient problems: Swelling/ Edema; Thrombosis/Thrombus

  MAUDE report 24454620 ↗
• MalfunctionDec 22, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED "THE PICC WAS ONLY INSERTED ON THE (B)(6) 2025 AND THE SPLIT WAS NOTED ON (B)(6) 2025 ON REMOVAL AS THE PATIENT WAS COMPLAINING OF PAIN ON FLUSHING WITH ALL OTHER CAUSES RULED OUT." THERE WAS NO PATIENT HARM OR INJURY. NO MEDICAL INTERVENTION REQUIRED. THE PATIENT'S CURRENT CONDITION IS UNKNOWN AT THIS TIME.

  Patient problems: Pain

  MAUDE report 23864669 ↗
• MalfunctionSep 24, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT "THE DILATOR TIP HAS SPLIT." 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 23132243 ↗
• MalfunctionJul 14, 2025Material Deformation; Material Deformation

  IT WAS REPORTED "OPENED PICC KIT READY FOR INSERTION STARTED PASSING GLIDE THRU PEEL AWAY SHEATH AND FOUND IT WAS NOT SMOOTH, IT WAS UNABLE TO BE USED. SO REMOVED OFF WIRE AND KEPT." ANOTHER DEVICE WAS USED. 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 22496563 ↗
• MalfunctionJul 10, 2025Difficult to Advance; Difficult to Advance

  IT WAS REPORTED THAT "THE INTERVENTIONAL RADIOLOGIST FACING THE CATHETER WAS NOT INSERTED IN VEIN PROPERLY ,EVEN 2ND TIME ALSO HE FACED THE SAME ISSUE. THEN HE CALLED ME TO REPLACE THAT." 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 22469038 ↗
• MalfunctionJul 2, 2025Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT "CATHETER KINKING AND BREAKAGE ISSUE REPORTED FROM CVAD DEPARTMENT. THE DEPARTMENT HAVE SHARED IMAGES OF 6-MONTH-OLD CATHETER WITH THE MENTIONED COMPLAINT. ANATOMICAL INSERTION SITE OF DEVICE: PERIPHERALLY UPPER ARM CATHETER FLOW GOT STUCK, TECHNICIANS HAVE TAKEN BACK THE BROKEN CATHETER FROM BODY. THERE WAS A DELAY IN THE PROCEDURE." 3 DEVICES WERE REPORTED. ASSOCIATED MDRS: 9680794-2025-00542, 9680794-2025-00540 AND 9680794-2025-00541.

  Patient problems: Insufficient Information

  MAUDE report 22390787 ↗
• MalfunctionJul 2, 2025Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT "CATHETER KINKING AND BREAKAGE ISSUE REPORTED FROM CVAD DEPARTMENT. THE DEPARTMENT HAVE SHARED IMAGES OF 6-MONTH-OLD CATHETER WITH THE MENTIONED COMPLAINT. ANATOMICAL INSERTION SITE OF DEVICE: PERIPHERALLY UPPER ARM CATHETER FLOW GOT STUCK, TECHNICIANS HAVE TAKEN BACK THE BROKEN CATHETER FROM BODY. THERE WAS A DELAY IN THE PROCEDURE." 3 DEVICES WERE REPORTED. ASSOCIATED MDRS: 9680794-2025-00542 AND 9680794-2025-00540.

  Patient problems: Insufficient Information

  MAUDE report 22390764 ↗
• MalfunctionJul 2, 2025Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT "CATHETER KINKING AND BREAKAGE ISSUE REPORTED FROM CVAD DEPARTMENT. THE DEPARTMENT HAVE SHARED IMAGES OF 6 MONTH OLD CATHETER WITH THE MENTIONED COMPLAINT. ANATOMICAL INSERTION SITE OF DEVICE: PERIPHERALLY UPPER ARM CATHETER FLOW GOT STUCK, TECHNICIANS HAVE TAKEN BACK THE BROKEN CATHETER FROM BODY. THERE WAS A DELAY IN THE PROCEDURE." 3 DEVICES WERE REPORTED. ASSOCIATED MDRS: 9680794-2025-00542, 9680794-2025-00540 AND 9680794-2025-00541.

  Patient problems: Insufficient Information

  MAUDE report 22390561 ↗
• MalfunctionSep 27, 2024Difficult to Advance; Material Too Soft/Flexible; Difficult to Advance; Material Too Soft/Flexible

  IT WAS REPORTED "THE PEEL-AWAY SHEATH COULD NOT BE INSERTED INTO THE BLOOD VESSEL." ADDITIONAL INFORMATION REPORTS, "IT IS TOO SOFT TO BE INSERTED SMOOTHLY." 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: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20321385 ↗
• MalfunctionJun 6, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED "LEAKED FROM THE JUNCTION OF THE HUB AND THE CATHETER DURING USE, AND THE PATIENT HAD NO SAFETY CONCERNS." THE DEVICE WAS REMOVED AND REPLACED. NO PATIENT HARM OR INJURY. THE PATIENT'S CURRENT CONDITION REPORTED "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19477345 ↗
• MalfunctionOct 12, 2023Difficult to Flush; Difficult to Flush

  IT WAS REPORTED THAT: THERE WAS DIFFICULTIES FLUSHING THE PICC LINE. ADDITIONAL INFORMATION: ACCESS WAS IN THE BASILIC VEIN. THERE WAS NO VISIBLE DAMAGE TO THE CATHETER REPORTED. THEY REMOVED THE ENTIRE CATHETER AND REPLACED WITH ANOTHER DEVICE. THERE WAS A DELAY TO TREATMENT BUT NO OTHER HARM OR CONSEQUENCE TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17918238 ↗
• MalfunctionAug 31, 2023Component Misassembled; Wrong Label; Component Misassembled; Wrong Label

  CUSTOMER REPORTED " WE OPENED A PICC LINE TODAY WHICH WAS LABELLED AS A DUAL LUMEN 5FR PICC ON THE PAPERWORK INSIDE THE PLASTIC BAG, BUT UPON OPENING THE BAG, THE STERILE PLASTIC TRAY CONTAINED A SINGLE LUMEN 4FR PICC PACKED INSIDE. LOT NO. 13F22M0077." NO PATIENT INVOLVEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17664781 ↗

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