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ARROW IPN037877Recalls & reported problems

Teleflex Incorporated · Pressure Injectable Arrowg+ard Blue Advance(R) Two-Lumen PICC 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
2
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 60801902132873), received between Aug 12, 2021 and Feb 1, 2022 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Deformation Due to Compressive Stress” (1 report).

7 other recalls cover devices cleared under the same FDA submission (K160925); 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

  • Deformation Due to Compressive Stress1
  • Material Deformation1

Patient problems

  • No Clinical Signs, Symptoms or Conditions2

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

  • MalfunctionFeb 1, 2022Deformation Due to Compressive Stress; Deformation Due to Compressive Stress

    CUSTOMER INDICATED WHEN THEY WENT TO OPEN THE KIT THE STYLET OUTSIDE OF THE PICC NOTED TO BE BENT AT 45 DEGREE ANGLE IN TRAY. THEY GRABBED ANOTHER STYLET AND USED IT WITH THE CATHETER THAT WAS IN THE KIT. NO PATIENT HARM REPORTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 13419132 ↗
  • MalfunctionAug 12, 2021Material Deformation; Material Deformation

    CUSTOMER REPORTS "AFTER PICC PLACED VERY DIFFICULT TO REMOVE WIRE. PICC LINE WAS RETRACTED UNTIL WIRE COULD BE REMOVED. RN NOTED WIRE WAS JAGGED AND ROUGH WHEN RAN FINGER ALONG THE LINE." NO PATIENT INJURY OR CONSEQUENCE REPORTED. THE PATIENT'S CONDITION IS REPORTED AS FINE.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 12312299 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K160925. One submission often covers many models, so check the product and lot details in each record.

  • Z-0004-2024 · Aug 10, 2023 · Open, Classified
    Arrow ErgoPack Pressure Injectable Arrowg+ard Blue Advance Three-Lumen PICC pre-loaded with Arrow VPS TipTracker Stylet, REF CDC-45563-TTS; catheter, intravascular, therapeutic, lo
  • Z-2383-2018 · May 17, 2018 · Terminated
    VPS Rhythm ECG Accessory Pack, REF RHY-100-ECGO Product Usage: To provide real time tip location information of a central venous catheter by utilization of ECG to observe P-wave c
  • Z-2384-2018 · May 17, 2018 · Terminated
    VPS TipTracker Stylet Accessory, REF RHY-177-TTSAP Product Usage: To provide real time tip location information of a central venous catheter by utilization of ECG to observe P-wav
  • Z-2382-2018 · May 17, 2018 · Terminated
    VPS Rhythm ECG Accessory Pack with Johans Adapter, REF RHY-100-ECGJ Product Usage: To provide real time tip location information of a central venous catheter by utilization of ECG
  • Z-2026-2018 · Apr 11, 2018 · Terminated
    VPS Rhythm ECG Accessory Pack with Johans Adapter; Product codes: RHY-100-ECGJ
  • Z-2027-2018 · Apr 11, 2018 · Terminated
    VPS Rhythm ECG Accessory Pack ; Product codes: RHY-100-ECGO
  • Z-2028-2018 · Apr 11, 2018 · Terminated
    VPS TipTracker Stylet Accessory; Product codes: RHY-177-TTSAP

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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