ARROW IPN032608Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10801902094220), received between May 27, 2021 and Jul 25, 2024 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Physical Resistance/Sticking” (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 16, 2026.

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 25, 2024Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED "THE CATHETER GOT TORN WHEN THE USER REMOVED THE FIXING TAPE DURING PLACEMENT. THEREFORE, IT WAS REMOVED AND REPLACED WITH A NEW KIT. NO HARM TO THE PATIENT OCCURRED." NO MEDICAL INTERVENTION REQUIRED. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19826194 ↗
• MalfunctionJun 2, 2024Crack; Fluid/Blood Leak; Crack; Fluid/Blood Leak

  IT WAS REPORTED "LEAK WAS FOUND FROM THE EXTENSION LINE DURING USE. THEREFORE, THE CATHETER WAS REMOVED AND REPLACED WITH A NEW ONE, BY WHICH THE PROCEDURE WAS COMPLETED WITHOUT PROBLEM. NO INJURY TO THE PATIENT OCCURRED." ADDITIONAL INFORMATION REPORTS "THERE WAS A CRACK IN THE EXTENSION LINE FROM WHICH A LEAK OCCURED". NO MEDICAL INTERVENTION REQUIRED. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19444840 ↗
• MalfunctionMar 21, 2024Material Twisted/Bent; Physical Resistance/Sticking; Material Twisted/Bent; Physical Resistance/Sticking

  IT WAS REPORTED THAT: "THE USER WAS UNABLE TO INSERT THE SWG THROUGH THE CATHETER BECAUSE OF RESISTANCE. THERE WAS NO REPORTED PATIENT HARM."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18947988 ↗
• MalfunctionOct 24, 2023Deformation Due to Compressive Stress; Difficult to Advance; Physical Resistance/Sticking; Deformation Due to Compressive Stress; Difficult to Advance; Physical Resistance/Sticking

  IT WAS REPORTED THAT THE USER FELT A RESISTANCE WHEN INSERTING THE SWG THROUGH THE CATHETER. THEREFORE, THE CATHETER AND THE SWG WERE REMOVED AND REPLACED WITH A NEW KIT. NO HARM TO THE PATIENT OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17994777 ↗
• MalfunctionJul 3, 2023Material Separation; Material Separation

  THE COMPLAINT IS REPORTED AS: "THE USER FOUND OUT THE CATHETER WAS INSERTED TOO DEEP THROUGH IMAGING AFTER INSERTING THE CVC INTO THE PATIENT, AND THEN, WHEN ADJUSTING THE POSITION AND DETACHING THE TAPE THE CATHETER WAS CUT OFF. POSITION ADJUSTMENT WAS PERFORMED BY A NURSE UNDER THE DIRECTION OF THE DOCTOR. A NEW KIT WAS USED AFTER THE EVENT OCCURRED." THE PATIENT'S CONDITION IS REPORTED AS FINE. ADDITIONAL INFORMATION WAS REQUESTED BUT WAS NOT AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17250896 ↗
• MalfunctionMay 27, 2021Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE STOPCOCK WAS CRACKED DURING USE, WHICH CAUSED A LEAK. THE DEVICE WAS REPLACED. NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11896770 ↗

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