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ARROW IPN927048Recalls & reported problems

Teleflex Incorporated · Pressure Injectable Arrowg+ard Blue Advance(R) One-Lumen PICC Kit pre-loaded with Arrow(R) VPS Precision(TM) Stylet · Class 2

All models of ARROW (1494)

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Adverse event reports
4
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10801902213102), received between Sep 25, 2023 and Sep 29, 2023 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Break” (4 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 18, 2026.

Most reported problems

Device problems

  • Break4
  • Difficult or Delayed Separation3

Patient problems

  • No Clinical Signs, Symptoms or Conditions4

Recent adverse event reports

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

  • MalfunctionSep 29, 2023Break; Break

    IT WAS REPORTED THE WHITE HANDLE ON THE PEELAWAY SHEATH BROKE OFF ON ONE SIDE JUST ABOVE WHERE THE BODY OF THE SHEATH ATTACHES TO THE HANDLES. THE CLINICIAN WAS ABLE TO USE A HEMOSTAT AND PEEL AWAY ONE SIDE OF THE SHEATH TO GET IT OFF THE INDWELLING LINE. THE PICC WAS INSERTED WITHOUT INCIDENT AFTER REMOVING THE BROKEN PEELAWAY. NO PATIENT HARM REPORTED. THE PATIENT'S CONDITION IS REPORTED AS FINE.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 17844065 ↗
  • MalfunctionSep 25, 2023Break; Difficult or Delayed Separation; Break; Difficult or Delayed Separation

    IT WAS REPORTED THE PEEL-AWAY SHEATH DID NOT PEEL CORRECTLY. THE SHEATH PEELED PART WAY AND THEN THE WHITE HANDLES BROKE AWAY FROM THE REST OF THE SHEATH THAT WAS AROUND THE PICC. THE CLINICIAN WAS ABLE TO USE A HEMOSTAT AND PEEL-AWAY ONE SIDE OF THE SHEATH TO GET IT OFF OF THE INDWELLING LINE. THE PICC WAS COMPLETED WITHOUT INCIDENT AFTER REMOVING THE BROKEN PEEL-AWAY. NO PATIENT HARM REPORTED. THE PATIENT'S CONDITION IS REPORTED AS FINE.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 17808705 ↗
  • MalfunctionSep 25, 2023Break; Difficult or Delayed Separation; Break; Difficult or Delayed Separation

    IT WAS REPORTED THE PEEL-AWAY SHEATH DID NOT PEEL CORRECTLY. THE SHEATH PEELED PART WAY AND THEN THE WHITE HANDLES BROKE AWAY FROM THE REST OF THE SHEATH THAT WAS AROUND THE PICC. THE CLINICIAN WAS ABLE TO USE A HEMOSTAT AND PEEL-AWAY ONE SIDE OF THE SHEATH TO GET IT OFF OF THE INDWELLING LINE. THE PICC WAS COMPLETED WITHOUT INCIDENT AFTER REMOVING THE BROKEN PEEL-AWAY. NO PATIENT HARM REPORTED. THE PATIENT'S CONDITION IS REPORTED AS FINE.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 17808416 ↗
  • MalfunctionSep 25, 2023Break; Difficult or Delayed Separation; Break; Difficult or Delayed Separation

    IT WAS REPORTED THE PEEL-AWAY SHEATH DID NOT PEEL CORRECTLY. THE SHEATH PEELED PART WAY AND THEN THE WHITE HANDLES BROKE AWAY FROM THE REST OF THE SHEATH THAT WAS AROUND THE PICC. THE CLINICIAN WAS ABLE TO USE A HEMOSTAT AND PEEL-AWAY ONE SIDE OF THE SHEATH TO GET IT OFF OF THE INDWELLING LINE. THE PICC WAS COMPLETED WITHOUT INCIDENT AFTER REMOVING THE BROKEN PEEL-AWAY. NO PATIENT HARM REPORTED. THE PATIENT'S CONDITION IS REPORTED AS FINE.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 17808208 ↗

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-1808-2019 · Apr 23, 2019 · Terminated
    Arrowg+ard Blue Advance" PICC pre loaded with Arrow VPS" Precision Stylet Product Code: CDC 45041 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-1810-2019 · Apr 23, 2019 · Terminated
    Arrowg+ard Blue Advance PICC pre loaded with Arrow VPS" Precision Stylet Product Code: CDC 45063 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 peripher
  • 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 peripher
  • 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

Other Catheter, intravascular, therapeutic, long-term greater than 30 days devices

All Catheter, intravascular, therapeutic, long-term greater than 30 days devices →

Sources and updates

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