ARROW IPN055871Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10801902159967), received between Jul 8, 2021 and Feb 23, 2026 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (2 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 23, 2026Fluid/Blood Leak; Material Puncture/Hole

  IT WAS REPORTED THAT "INSERTED (B)(6) 2025, DISCOVERED PINK HUB LEAKING ON (B)(6) 2025. CATHETER REMOVED. THEY SAW A PINHOLE. CATHETER WAS REPLACED WITH ANOTHER PICC". THERE WAS NO PATIENT HARM OR INJURY. THE PATIENT'S CURRENT CONDITION IS UNKNOWN AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24414297 ↗
• MalfunctionDec 2, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT "FLUID LEAKING FROM THE EXTERNAL CLEAR PORTION OF THE WHITE LUMEN, A FEW MM FROM THE HUB." ADDITIONAL INFORMATION PROVIDED INCLUDES "I ORIGINALLY ATTEMPTED TO EXCHANGE OVER WIRE TO MINIMIZE PROCEDURE TIME BUT COULD NOT GET THE LAST 4-6CM OF THE NEW PICC TO ADVANCE. WHEN HE BECAME UNABLE TO TOLERATE MY TROUBLESHOOTING, I ABORTED THE EXCHANGE ATTEMPT OUT OF CONCERN FOR MAINTAINING MY STERILE FIELD. MD ASKED ME TO TRY ON THE LEFT, AND THAT PROCEDURE WENT SMOOTHLY." 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 23693221 ↗
• MalfunctionNov 3, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT "PINK HUB DETACHED WHEN ROLLING/REPOSITIONING PATIENT. PATIENT SELF DISCONTINUED PICC THE DAY BEFORE - HARD TO CONFIRM IF DAMAGE DUE TO PATIENT OR STAFF OR BOTH." 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 23452309 ↗
• MalfunctionFeb 23, 2024Separation Problem; Separation Problem

  IT WAS REPORTED " AS THE NURSE WAS TEARING THE SHEATH, IT TORE OFF IN HER HAND. SHE SAID IT HAD FELT FLIMSY." NO MEDICAL INTERVENTION REQUIRED. NO PATIENT HARM OR INJURY. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18770300 ↗
• MalfunctionAug 22, 2023Obstruction of Flow; Obstruction of Flow

  THE COMPLAINT IS REPORTED AS: PICC INSERTED WITHOUT INCIDENT ON (B)(6) 2023 AT 1105. THE WHITE LUMEN WAS FOUND NOT FLUSHING/ASPIRATING AT 1328 ON THE SAME DAY. NURSE CHECKED DRESSING AND FOUND NO MECHANICAL ISSUES. PICC WAS SUCCESSFULLY EXCHANGED. THE PATIENT'S CONDITION IS REPORTED AS FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17597238 ↗
• MalfunctionMay 2, 2023Deformation Due to Compressive Stress; Deformation Due to Compressive Stress

  IT WAS REPORTED THE GUIDEWIRE DOES NOT FULLY ADVANCE, BUT THE SHEATH, PICC, AND BUDDY WIRE ALL ADVANCE AND THE CATHETER WAS PLACED. RESISTANCE WAS NOTED WHEN INSERTING THE WIRE. NO PATIENT HARM REPORTED. THE PATIENT'S CONDITION IS REPORTED AS FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16853317 ↗
• MalfunctionJul 8, 2021Material Separation; Material Separation

  THE COMPLAINT IS REPORTED AS: "NURSES CAME ACROSS PICC WITH PINK HUB OFF." NO PATIENT HARM REPORTED. THE PATIENT'S CONDITION IS REPORTED AS FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12134204 ↗

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-1807-2019 · Apr 23, 2019 · Terminated
  Arrowg+ard Blue Advance PICC pre loaded with Arrow VPS" Precision Stylet Product Code: CDC 44063 VPS2
• 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-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