ARROW IPN924163Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10801902208672), received between Sep 7, 2023 and Jul 9, 2025 — classified as 8 malfunctions.

The most frequently reported specific device problem is “Material Twisted/Bent” (3 reports).

1 FDA recall record name this device's identifier, 1 still open.

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.

Recalls naming this device

1. Apr 21, 2026Open, Classified

   Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and sets. The supplier was found to have quality issues and limited reports of drug ineffectiveness, and if sterility of a water-based injectable product is compromised this could lead to serious or life-threatening injuries.

   Z-2394-2026 · Root cause: Nonconforming Material/Component · FDA record ↗

Most reported problems

Recent adverse event reports

The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 9, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED "PICC WAS INSERTED IN MARCH FOR CHEMO. THE PATIENT WAS HAVING CHEMO ON (B)(6) 2025 AND BLOOD STARTED DRIPPING OUT OF THE EXTENSION LINE OF THE WHITE PORT." 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 22457224 ↗
• MalfunctionJul 3, 2025Obstruction of Flow; Material Twisted/Bent; Obstruction of Flow; Material Twisted/Bent

  IT WAS REPORTED "PICC WAS PLACED ON (B)(6) 2025. THE NURSES WEREN'T ABLE TO ASPIRATE OR FLUSH ON (B)(6) 2025 SO THEY HAD TO REMOVE THE LINE AND SAW HOW THE CATHETER WAS KINKED IN 2 PLACES, WHICH IS THE LOCATION OF WHERE THE KINK WOULD HAVE BEEN IN THE ARMPIT ACCORDING TO INSERTER." 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 22396509 ↗
• MalfunctionJun 20, 2025Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED "PICC WAS INSERTED ON (B)(6) 2025 AS AN OUTPATIENT. HOME HEALTH SAID FROM THE BEGINNING THE PICC WAS SLUGGISH. THEY GAVE THE PATIENT TPA MULTIPLE TIMES AND IT WOULD HELP THEN THIS PAST WEEK IT WOULDN'T HELP AT ALL SO PATIENT CAME TO ED TO GET IT REPLACED. WHEN THEY PULLED THE PICC OUT THEY SAW THE PICC WAS KINKED IN MULTIPLE PLACES." 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 22298416 ↗
• MalfunctionAug 30, 2024Material Too Soft/Flexible; Material Too Soft/Flexible

  IT WAS REPORTED THAT: "PICC'S ARE TOO SOFT AND WE ARE SEEING MORE KINKING. THERE WAS NO REPORTED PATIENT HARM OR CONSEQUENCE." ASSOCIATED COMPLAINTS (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20106607 ↗
• MalfunctionAug 28, 2024Product Quality Problem; Material Twisted/Bent; Product Quality Problem; Material Twisted/Bent

  IT WAS REPORTED THAT: "PICC WAS PLACED AND 2 DAYS LATER IT WAS KINKED IN MULTIPLE PLACES. A NEW PICC WAS NEEDED TO BE PLACED. THE THERAPY WAS DELAYED, INTERRUPTED. THE ACCOUNT IS SAYING THE PICC IS TOO SOFT." THERE WAS NO REPORTED PATIENT HARM OR CONSEQUENCE. ASSOCIATED COMPLAINTS 9680794-2024-00911 AND 9680794-2024-00811.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20083746 ↗
• MalfunctionJul 15, 2024Material Separation; Material Separation

  IT WAS REPORTED "PATIENT FELL AND PICC HUB BROKE OFF". 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 19742986 ↗
• MalfunctionSep 13, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT: RIGHT HUB BROKE OFF DURING REMOVAL OF SHEATH OUTSIDE PATIENT. THE DEFECT WAS DETECTED DURING USE ON PATIENT. THE PATIENT CONDITION WAS REPORTED AS "FINE". NO PATIENT INJURY/CONSEQUENCE OR MEDICAL INTERVENTION REPORTED. ADDITIONAL INFORMATION: THE ENTIRE SHEATH WAS REMOVED. NONE LEFT IN PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17735759 ↗
• MalfunctionSep 7, 2023Break; Break

  IT WAS REPORTED THE SHEATH "BROKE AT THE RIGHT SIDE OF THE HUB OF SHEATH INTRODUCER, APART FROM THE CATHETER". THE INSERTION SITE WAS THE UPPER ARM. THE SHEATH WAS REMOVED IN ITS ENTIRETY, NOTHING WAS LEFT BEHIND. NO PATIENT HARM OR INJURY OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17703101 ↗

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