ARROW IPN037447Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 40801902125536), received between May 8, 2024 and May 8, 2024 — classified as 1 injury.

The most frequently reported specific device problem is “Malposition of Device” (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 18, 2026.

Most reported problems

Recent adverse event reports

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

• InjuryMay 8, 2024Malposition of Device; Migration; Malposition of Device; Migration

  IT WAS REPORTED THAT: " PATIENT HAD A PICC LINE FOR BLOODS AND IV ANTIBIOTICS, AND IT WAS NOTICED THAT THE PICC LUMEN WAS NOT IN PLACE ONLY THE DRESSING, PATIENT HAD A SPIKE OF TEMPERATURE AROUND THE TIME AND AS PART OF SEPTIC SCREEN CHEST X-RAY WAS PERFORMED AND PART OF THE HUMERUS WAS X-RAYED, WHICH REVEALED PICC LUMEN AND THE CLIP INSIDE PATIENT SKIN. PATIENT WAS THEN TAKEN TO THEATRE TO HAVE IT REMOVED UNDER LOCAL ANESTHETIC".

  Patient problems: Fever; Foreign Body In Patient

  MAUDE report 19273514 ↗

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-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-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
• Z-2026-2018 · Apr 11, 2018 · Terminated
  VPS Rhythm ECG Accessory Pack with Johans Adapter; Product codes: RHY-100-ECGJ