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ARROW IPN920600Recalls & reported problems

Teleflex Incorporated · VPS TipTracker(TM) Stylet Accessory · Class 2

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 10801902195903), received between Mar 3, 2023 and Mar 3, 2023 — classified as 1 malfunction.

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

  • Material Separation1

Patient problems

  • Insufficient Information1

Recent adverse event reports

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

  • MalfunctionMar 3, 2023Material Separation; Material Separation

    IT WAS REPORTED THAT: "DURING INSERTION OF AN IMPLANTABLE PORT CATHETER, THE METAL STYLET OF THE VPS BROKE (WHEN REMOVING THE DEVICE FROM THE CATHETER) WITHOUT FORCING. THE ENTIRE STYLET WAS RECOVERED. A CONTROL X-RAY SHOWED NO METALLIC RESIDUE IN THE CATHETER OR WITHOUT THE PATIENT'S THORACIC VESSELS."

    Patient problems: Insufficient Information

    MAUDE report 16481727 ↗

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-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-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-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-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

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