ARROW IPN037512Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10801902127881), received between Dec 1, 2021 and Jan 8, 2024 — 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

Recent adverse event reports

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

• MalfunctionJan 8, 2024Smoking; Smoking

  CUSTOMER REPORTED UPON BOOT UP THE MONITOR STARTED TO SMOKE. THEY SHUT DOWN AND DISCONTINUED USING THE DEVICE. THEY HAD ANOTHER DEVICE SO THEY COULD PROCEED WITH THE NEXT CASE. THE REPORTED DEFECT WAS DETECTED PRIOR TO USE (IN A CLINICAL SETTING). THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18462299 ↗
• MalfunctionMay 20, 2022Smoking; Smoking

  CUSTOMER REPORTED THEIR MONITOR SHORTED OUT AND STARTED SMOKING. IT WILL NOT TURN BACK ON. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14457360 ↗
• 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 12912858 ↗

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-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-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