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ARROW IPN037371Recalls & reported problems

Teleflex Incorporated · VPS Rhythm(TM) Monitor Bundle · Class 2

All models of ARROW (1494)

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

Adverse event reports
3
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10801902114652), received between May 5, 2021 and Feb 4, 2022 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Smoking” (2 reports).

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

  • Smoking2
  • Positioning Failure1

Patient problems

  • No Clinical Signs, Symptoms or Conditions3

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

  • MalfunctionFeb 4, 2022Smoking; Smoking

    CUSTOMER REPORTED DURING BOOT UP THE SYSTEM GOT AN ERROR MESSAGE "POWER SUPPLY FAILURE". MACHINE POWERED DOWN AND REBOOTED AT WHICH SMOKE AND A BURNING SMELL WAS EMITTED FROM THE UNIT. CUSTOMER CONFIRMED ALL CONNECTIONS WERE GOOD. NO PATIENT HARM REPORTED. THE PATIENT'S CONDITION IS REPORTED AS FINE. T-PIECE ASSOCIATED WITH DEVICE IS CAPTURED IN MDR REPORT # 3011137372-2022-00019 (RHY-100-TP).

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 13458300 ↗
  • MalfunctionDec 1, 2021Positioning Failure; Positioning Failure

    CUSTOMER REPORTS TIP PLACEMENTS CHECKED BY CHEST X-RAY ARE INCONSISTENT WITH READINGS PROVIDED BY THE VPS RHYTHM. NO PATIENT HARM REPORTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 12912562 ↗
  • MalfunctionMay 5, 2021Smoking; Smoking

    CUSTOMER INDICATED THEIR MONITOR STARTED SMOKING AND IS NO LONGER WORKING. NO PATIENT INVOLVEMENT REPORTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 11776706 ↗

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-2028-2018 · Apr 11, 2018 · Terminated
    VPS TipTracker Stylet Accessory; Product codes: RHY-177-TTSAP
  • Z-2027-2018 · Apr 11, 2018 · Terminated
    VPS Rhythm ECG Accessory Pack ; Product codes: RHY-100-ECGO

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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