Skip to content

ARROW IPN037302Recalls & reported problems

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

Data updated Oct 13, 2026 from official FDA records · Editorial policy

1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.

Adverse event reports
4
Deaths reported
0
Injuries reported
0
Recalls naming it
1

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 50801902120699), received between Oct 11, 2021 and Sep 8, 2023 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Break” (2 reports).

1 FDA recall record name this device's identifier, 1 still open.

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. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

  1. Apr 21, 2026Open, Classified

    Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and sets. The supplier was found to have quality issues and limited reports of drug ineffectiveness, and if sterility of a water-based injectable product is compromised this could lead to serious or life-threatening injuries.

    Z-2394-2026 · Root cause: Nonconforming Material/Component · FDA record ↗

Most reported problems

Device problems

  • Break2
  • Fluid/Blood Leak1
  • Material Separation1

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 8, 2023Material Separation; Material Separation

    IT WAS REPORTED THAT: THE TAB OF THE PEEL AWAY SHEATH SNAPPED OFF WHILE ATTEMPTING TO PEAL IT APART. IT HAPPENED DURING USE ON PATIENT BUT THERE WAS NO REPORTED PATIENT HARM OR CONSEQUENCE.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 17709746 ↗
  • MalfunctionSep 6, 2023Break; Break

    IT WAS REPORTED "WHILE ATTEMPTING TO PEEL THE PEEL AWAY SHEATH, ONE SIDE OF THE WHITE SHEATH HUB BROKE OFF". THE PATIENT'S CONDITION IS REPORTED AS FINE.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 17692735 ↗
  • MalfunctionAug 23, 2023Break; Break

    IT WAS REPORTED WHILE ATTEMPTING TO PEEL THE PEEL-AWAY SHEATH, ONE SIDE OF THE WHITE SHEATH TAB BROKE OFF. THE USER USED THE WHITE PORTION OF THE SHEATH THAT WAS STILL INTACT AND PULLED THE CATHETER TO THE OPPOSITE SIDE TO BREAK THE SHEATH. THE SHEATH WAS REMOVED. NO PATIENT HARM REPORTED. THE PATIENT'S CONDITION IS REPORTED AS FINE.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 17607301 ↗
  • MalfunctionOct 11, 2021Fluid/Blood Leak; Fluid/Blood Leak

    IT WAS REPORTED THE LINE WAS LEAKING NEAR THE CAP. THE PICC WAS REMOVED AND A NEW ONE INSERTED. NO PATIENT HARM REPORTED. THE PATIENT'S CONDITION IS REPORTED AS FINE.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 12609807 ↗

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-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-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

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

How reports and recalls are matched · Editorial policy · Report an error on this page