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ARROW IPN056676Recalls & reported problems

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

All models of ARROW (1494)

Data updated Oct 16, 2026 from official FDA records · Editorial policy

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

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10801902167658), received between Mar 22, 2021 and Mar 22, 2021 — classified as 1 malfunction.

The most frequently reported specific device problem is “Material Deformation” (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

Device problems

  • Material Deformation1

Patient problems

  • No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • MalfunctionMar 22, 2021Material Deformation; Material Deformation

    THE COMPLAINT IS REPORTED AS: THE SHEATH BENT BACK SLIGHTLY AND MUSHROOMED AT THE DISTAL END OF THE SHEATH WHEN THE USER INITIALLY ATTEMPTED TO PLACE IT. A 4F TELEFLEX SHEATH/DILATOR WAS USED TO CONTINUE PLACEMENT BUT ULTIMATELY REPLACED WITH A 5F BARD SHEATH/DILATOR IN ORDER TO INSERT THE PICC. NO PATIENT INJURY OR HARM REPORTED. THE PATIENT'S CONDITION IS REPORTED AS FINE.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 11544207 ↗

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