ARROW IPN037308 (REF CDC-44052-VPS2)Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 50801902120705), received between Jul 21, 2021 and Jun 20, 2025 — classified as 10 malfunctions.

The most frequently reported specific device problem is “Material Separation” (5 reports).

8 other recalls cover devices cleared under the same FDA submission (K153487); 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 20, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED "PICC WAS INSERTED ON (B)(6) 2023 AS AN OUTPATIENT. PATIENT HAS BEEN GETTING CHEMO SINCE THEN. THEN ON (B)(6) 2025 WHEN THE PATIENT CAME IN FROM CHEMO, THEY SAW THE PINK PORT WAS LEAKING. THEY WILL HAVE TO EXCHANGE THE PICC OUT." 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 22298805 ↗
• MalfunctionMay 7, 2025Leak/Splash; Leak/Splash

  IT WAS REPORTED "ORIGINALLY INSERTED ON (B)(6) 2025 AND REMOVED (B)(6) 2025 DUE TO LEAKING EXTENSION LINE. CATHETER WAS TUNNELED AT TIME OF INSERTION. GUIDEWIRE EXCHANGE FOR A NEW TUNNELED CATHETER. THERE WAS A DELAY IN THERAPY BECAUSE ISSUE WAS NOTICED ON A SUNDAY AND LINE EXCHANGE WAS NOT POSSIBLE UNTIL TUESDAY (B)(6). PATIENT HAS SHORT GUT SYNDROME AND HAS CONTINUOUS MEDICATIONS RUNNING 24 HOURS A DAY. HE WAS NOT ABLE TO TAKE A BREAK ON INFUSIONS BECAUSE ALL MEDS HAD TO RUN THROUGH THE ONE WORKING LINE. THE LEAK WAS NOTICED ON THE DISTAL LUMEN WHERE THE CLEAR EXTENSION LINE MEETS THE PINK END HUB." 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 21977261 ↗
• MalfunctionOct 14, 2024Unraveled Material; Unraveled Material

  IT WAS REPORTED "THE DISTAL FLOPPY TIP OF THE ACCESS WIRE, BROKE AND UNCOILED, OUTSIDE THE VASCULATURE, WHEN IT WAS BEING WIPED POST REMOVAL/AFTER SUCCESS INSERTION/USE WAS COMPLETED. SAME DISTAL FLOPPY WIRE TIP WAS VERIFIED AS FULLY INTACT PRE AND POST INSERTION, AND THERE WAS NO PATIENT ISSUE." 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 20440515 ↗
• MalfunctionApr 8, 2024Difficult to Remove; Material Separation; Difficult to Remove; Material Separation

  IT WAS REPORTED "BOTH TABS BROKE OFF WHEN ATTEMPTING TO PEEL INTRODUCER SHEATH AWAY AT END OF CASE". 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 19059969 ↗
• MalfunctionApr 8, 2024Material Separation; Material Separation

  IT WAS REPORTED "ONE OF THE TABS BROKE OFF WHEN ATTEMPTING TO PEEL INTRODUCER SHEATH AWAY AT END OF CASE". 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 19059183 ↗
• MalfunctionDec 18, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT: HANDLE OF SHEATH BROKE OFF DURING INSERTION. THE REPORTED DEFECT WAS DETECTED DURING USE ON PATIENT. THE PATIENT CONDITION WAS REPORTED AS "FINE". NO PATIENT INJURY/CONSEQUENCE OR MEDICAL INTERVENTION REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18347355 ↗
• MalfunctionDec 15, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT: THE HANDLES OF THE SHEATH BROKE OFF. THE REPORTED DEFECT WAS DETECTED DURING USE ON PATIENT. THE PATIENT CONDITION WAS REPORTED AS "FINE". NO PATIENT INJURY/CONSEQUENCE OR MEDICAL INTERVENTION REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18333802 ↗
• MalfunctionAug 4, 2021Material Separation; Material Separation

  THE COMPLAINT IS REPORTED AS: HUB SEPARATION FROM EXTENSION LINE. PICC INSERTED ON (B)(6) 2021. NO PATIENT INJURY OR COMPLICATION REPORTED. THE PATIENT'S CONDITION IS REPORTED AS FINE. IT WAS REPORTED THERE WAS A DELAY IN THERAPY WITHOUT HARM TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12276867 ↗
• MalfunctionJul 29, 2021Fluid/Blood Leak; Fluid/Blood Leak

  PICC PLACED ON (B)(6) 2021. PATIENT CAME INTO INFUSION CENTER AND WHEN THEY WENT TO FLUSH THE PICC THEY NOTICED THE PICC WAS LEAKING ON THE EXTENSION LINE AT THE HUB ON THE DISTAL PORT. NO PATIENT HARM REPORTED. THE PATIENT'S CONDITION IS REPORTED AS FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12248956 ↗
• MalfunctionJul 21, 2021Fluid/Blood Leak; Fluid/Blood Leak

  THE COMPLAINT IS REPORTED AS: PICC IS LEAKING AT HUB. NO PATIENT HARM REPORTED. IT WAS REPORTED THERAPY WAS DEALYED/INTERRUPTED WITHOUT CONSEQUENCE FOR THE PATIENT. THE PATIENT'S CONDITION IS REPORTED AS FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12206001 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K153487. One submission often covers many models, so check the product and lot details in each record.

• Z-0001-2024 · Aug 10, 2023 · Open, Classified
  Arrow ErgoPack, Pressure Injectable Arrowg+ard Blue Advance Two-Lumen PICC pre-loaded with Arrow VPS Precision Stylet, REF CDC-45552-VPS2; Catheter: Percutaneous Implanted Long-Ter
• Z-1810-2019 · Apr 23, 2019 · Terminated
  Arrowg+ard Blue Advance PICC pre loaded with Arrow VPS" Precision Stylet Product Code: CDC 45063 VPS2
• Z-1807-2019 · Apr 23, 2019 · Terminated
  Arrowg+ard Blue Advance PICC pre loaded with Arrow VPS" Precision Stylet Product Code: CDC 44063 VPS2
• Z-1808-2019 · Apr 23, 2019 · Terminated
  Arrowg+ard Blue Advance" PICC pre loaded with Arrow VPS" Precision Stylet Product Code: CDC 45041 VPS2
• Z-1365-2019 · Dec 13, 2018 · Terminated
  Arrow PICC powered by Arrow VPS Precision Stylet Product Code:CDC-45052-VPS2 Product Usage: The Arrow Pressure Injectable PICC is indicated for short-term or longterm peripheral a
• Z-1366-2019 · Dec 13, 2018 · Terminated
  Arrow PICC powered by Arrow VPS Precision Stylet Product Code:CDC-44052-VPS2 Product Usage: The Arrow Pressure Injectable PICC is indicated for short-term or longterm peripheral a
• Z-3200-2018 · Jul 17, 2018 · Terminated
  5.5 Fr x 40 cm double-lumen PICC Kit, Product Code CDC-44052-VPS2
• Z-3199-2018 · Jul 17, 2018 · Terminated
  4.5 Fr x 40 cm single-lumen PICC Kit, Product Code CDC-44041-VPS2, 5.5 Fr double-lumen PICC Kit, Product Code CDC-44052-VPS2