ARROW IPN033558Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00801902095824), received between Nov 16, 2023 and Nov 14, 2025 — classified as 1 injury, 3 malfunctions.

The most frequently reported specific device problem is “Material Puncture/Hole” (2 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryNov 14, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED "THE CATHETER WAS REMOVED DUE TO A SUSPECTED INFECTION." THE CUSTOMER STATED THEY SUSPECT A RELATIONSHIP BETWEEN THE CATHETER AND THE INFECTION. ANTIBIOTIC TREATMENT WAS PROVIDED. THERE WAS NO PATIENT HARM OR INJURY. NO MEDICAL INTERVENTION REQUIRED. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE". ASSOCIATED MDR NUMBERS INCLUDE: 9680794-2025-00928 AND 9680794-2025-00792.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23554261 ↗
• MalfunctionSep 24, 2025Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT "THE PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER (PICC) WAS REMOVED FROM THE PATIENT PER THE TREATING PHYSICIAN'S ORDER. UPON REMOVAL, THE CATHETER WAS OBSERVED TO BE FRACTURED AT ITS DISTAL AND MID SEGMENTS." 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 23133086 ↗
• MalfunctionJun 9, 2025Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED "AN OBSTRUCTION IN THE DRUM DEVICE WAS EVIDENCED DURING THE RETURN VERIFICATION, WHICH PREVENTED THE ADVANCE OF THE SALINE SOLUTION. IT WAS INITIALLY THOUGHT THAT THE OBSTRUCTION WAS FROM THE PATIENT;HOWEVER, AFTER A NEW VERIFICATION, IT WAS CONFIRMED THAT THE OCCLUSION WAS LOCATED IN A PROXIMAL AREA OF THE MEDICAL DEVICE CONNECTORS. A DRUM DEVICE WAS INSERTED. ONCE INSERTED, A RETURN FLOW TEST WAS PERFORMED. THIS REVEALED A DRUM OBSTRUCTION. INITIALLY, IT WAS THOUGHT TO BE THE PATIENT'S. THE RETURN FLOW WAS VERIFIED AGAIN BY SWEEPING WITH 0.9% SSN. AN OCCLUSION OF THE DEVICE WAS OBSERVED IN AN AREA CLOSE TO THE CONNECTORS, WHICH PREVENTED THE DEVICE FROM PROGRESSING." 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 22166497 ↗
• MalfunctionNov 16, 2023Material Puncture/Hole; Deformation Due to Compressive Stress; Material Puncture/Hole; Deformation Due to Compressive Stress

  IT WAS REPORTED THAT: THE CATHETER WAS NOTED TO HAVE DEFORMITIES AND BENDS ON IT. THE ISSUE WAS IDENTIFIED PRIOR TO INSERTING INTO PATIENT. THERE WAS NO PATIENT HARM OR CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18149084 ↗

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