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ARROW IPN919527Recalls & reported problems

Teleflex Incorporated · Pressure Injectable Arrowg+ard Blue Advance(R) Two-Lumen PICC pre-loaded with Arrow(R) VPS Precision(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 10801902188219), received between Apr 7, 2023 and Apr 7, 2023 — classified as 1 malfunction.

The most frequently reported specific device problem is “Premature Separation” (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

  • Premature Separation1

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.

  • MalfunctionApr 7, 2023Premature Separation; Premature Separation

    IT WAS REPORTED "THE SHEATH SPLIT INSIDE PATIENT WHILE TRYING TO THREAD PICC INTO PATIENT." ADDITIONAL INFORMATION RECEIVED STATED THAT ALL PIECES OF THE SHEATH WERE RETRIEVED FROM THE PATIENT WITHOUT MEDICAL OR SURGICAL INTERVENTION. FURTHERMORE, THE CATHETER WAS ABLE TO BE PLACED. PATIENT CONDITION REPORTED AS "FINE".

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 16700405 ↗

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-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