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ARROW IPN920209Recalls & reported problems

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

All models of ARROW (1494)

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

Adverse event reports
8
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10801902192568), received between Feb 22, 2022 and Feb 28, 2022 — classified as 8 malfunctions.

The most frequently reported specific device problem is “Difficult to Advance” (8 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 16, 2026.

Most reported problems

Device problems

  • Difficult to Advance8
  • Physical Resistance/Sticking8

Patient problems

  • No Clinical Signs, Symptoms or Conditions8

Recent adverse event reports

The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

  • MalfunctionFeb 28, 2022Difficult to Advance; Physical Resistance/Sticking; Difficult to Advance; Physical Resistance/Sticking

    IT WAS REPORTED THE CATHETER WOULD NOT PASS THROUGH THE PEEL-AWAY SHEATH. A NEW KIT WAS OPENED TO COMPLETE THE PROCEDURE. NO PATIENT HARM REPORTED. THE PATIENT'S CONDITION IS REPORTED AS FINE.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 13624873 ↗
  • MalfunctionFeb 28, 2022Difficult to Advance; Physical Resistance/Sticking; Difficult to Advance; Physical Resistance/Sticking

    IT WAS REPORTED THE CATHETER WOULD NOT PASS THROUGH THE PEEL-AWAY SHEATH. A NEW KIT WAS OPENED TO COMPLETE THE PROCEDURE. NO PATIENT HARM REPORTED. THE PATIENT'S CONDITION IS REPORTED AS FINE.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 13624794 ↗
  • MalfunctionFeb 28, 2022Difficult to Advance; Physical Resistance/Sticking; Difficult to Advance; Physical Resistance/Sticking

    IT WAS REPORTED THE CATHETER WOULD NOT PASS THROUGH THE PEEL-AWAY SHEATH. A NEW KIT WAS OPENED TO COMPLETE THE PROCEDURE. NO PATIENT HARM REPORTED. THE PATIENT'S CONDITION IS REPORTED AS FINE.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 13624761 ↗
  • MalfunctionFeb 28, 2022Difficult to Advance; Physical Resistance/Sticking; Difficult to Advance; Physical Resistance/Sticking

    IT WAS REPORTED THE CATHETER WOULD NOT PASS THROUGH THE PEEL-AWAY SHEATH. A NEW KIT WAS OPENED TO COMPLETE THE PROCEDURE. NO PATIENT HARM REPORTED. THE PATIENT'S CONDITION IS REPORTED AS FINE.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 13624690 ↗
  • MalfunctionFeb 22, 2022Difficult to Advance; Physical Resistance/Sticking; Difficult to Advance; Physical Resistance/Sticking

    CUSTOMER REPORTED PICC LINE WOULD NOT ADVANCE INTO THE PEEL-AWAY SHEATH. THE DISTAL END OF THE CATHETER ADVANCED BUT THEY WERE UNABLE TO ADVANCE THE ENTIRE PICC. THEY WERE FINALLY ABLE TO "FORCE" THE CATHETER THROUGH THE SHEATH AND COMPLETE THE PROCEDURE. NO PATIENT HARM REPORTED. THE PATIENT'S CONDITION IS REPORTED AS FINE.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 13578193 ↗
  • MalfunctionFeb 22, 2022Difficult to Advance; Physical Resistance/Sticking; Difficult to Advance; Physical Resistance/Sticking

    CUSTOMER REPORTED PICC LINE WOULD NOT ADVANCE INTO THE PEEL-AWAY SHEATH. THE DISTAL END OF THE CATHETER ADVANCED BUT THEY WERE UNABLE TO ADVANCE THE ENTIRE PICC. THEY WERE FINALLY ABLE TO "FORCE" THE CATHETER THROUGH THE SHEATH AND COMPLETE THE PROCEDURE. NO PATIENT HARM REPORTED. THE PATIENT'S CONDITION IS REPORTED AS FINE.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 13578139 ↗
  • MalfunctionFeb 22, 2022Difficult to Advance; Physical Resistance/Sticking; Difficult to Advance; Physical Resistance/Sticking

    CUSTOMER REPORTED PICC LINE WOULD NOT ADVANCE INTO THE PEEL-AWAY SHEATH. THE DISTAL END OF THE CATHETER ADVANCED BUT THEY WERE UNABLE TO ADVANCE THE ENTIRE PICC. THEY WERE FINALLY ABLE TO "FORCE" THE CATHETER THROUGH THE SHEATH AND COMPLETE THE PROCEDURE. NO PATIENT HARM REPORTED. THE PATIENT'S CONDITION IS REPORTED AS FINE.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 13577906 ↗
  • MalfunctionFeb 22, 2022Difficult to Advance; Physical Resistance/Sticking; Difficult to Advance; Physical Resistance/Sticking

    CUSTOMER REPORTED PICC LINE WOULD NOT ADVANCE INTO THE PEEL-AWAY SHEATH. THE DISTAL END OF THE CATHETER ADVANCED BUT THEY WERE UNABLE TO ADVANCE THE ENTIRE PICC. THEY WERE FINALLY ABLE TO "FORCE" THE CATHETER THROUGH THE SHEATH AND COMPLETE THE PROCEDURE. NO PATIENT HARM REPORTED. THE PATIENT'S CONDITION IS REPORTED AS FINE.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 13577849 ↗

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 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

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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