ARROW IPN038494Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10801902140781), received between Jul 20, 2021 and Oct 1, 2023 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Break” (1 report).

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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 1, 2023Break; Break

  IT WAS REPORTED WHILE ATTEMPTING TO PEEL THE PEEL-AWAY SHEATH, ONE SIDE OF THE WHITE SHEATH HUB BROKE OFF. CLINICIAN USED THE LEVERAGE OF THE PICC AND ONE WHITE WING TO CONTINUE TO PEEL THE SHEATH EVEN THOUGH THE OTHER WHITE HUB BROKE OFF. PROCEDURE COMPLETED WITHOUT NEEDING TO DROP AN ADDITIONAL SHEATH. THE PATIENT'S CONDITION IS REPORTED AS FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17849438 ↗
• MalfunctionFeb 16, 2023Material Separation; Material Separation

  AFTER PHYSICAL THERAPY, NURSE ASSESSED THE LINE AND NOTED THAT IT WAS "BROKEN". RN IMMEDIATELY CALLED THE VASCULAR ACCESS TEAM WHO ASSESSED THE LINE AND REMOVED IT. PATIENT REMAINED VITALLY STABLE WITH NO BLOOD NOTED IN TUBING. PATIENT DENIED ANY DIFFICULTY BREATHING. OCCLUSIVE DRESSING APPLIED TO SITE AND NEW PICC INSERTED TO RIGHT CEPHALIC VEIN. IT WAS REPORTED THE PATIENT IS A FULL ASSIST WHEN DOING PHYSICAL THERAPY AND THE PATIENT IS UNSURE OF WHAT MAY HAVE HAPPENED DURING THERAPY. NO PATIENT HARM WAS REPORTED. THE PATIENT WAS REPORTED TO BE "STABLE, PENDING DISCHARGE" AT THE TIME OF THIS REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16386671 ↗
• MalfunctionDec 21, 2021Material Puncture/Hole; Material Puncture/Hole

  CLINICIAN NOTICED A PIN HOLE IN LUMEN EXTENSION TUBING, APPROXIMATELY WHERE IT MEETS THE EXTENSION SET LUMEN HUB. NO PATIENT HARM REPORTED. THE PATIENT'S CONDITION IS REPORTED AS FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13055540 ↗
• MalfunctionJul 20, 2021Physical Resistance/Sticking; Physical Resistance/Sticking

  PICC WAS BEING THREADED THROUGH SHEATH, UNABLE TO THREAD LAST 5CM'S OF PICC, WAS UNABLE TO PULL PICC BACK EITHER, PICC AND SHEATH REMOVED. NO PATIENT HARM REPORTED. NO MEDICAL INTERVENTION REQUIRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12198140 ↗

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-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-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-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
• Z-3200-2018 · Jul 17, 2018 · Terminated
  5.5 Fr x 40 cm double-lumen PICC Kit, Product Code CDC-44052-VPS2