ARROW IPN036759Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 50801902123782), received between Aug 22, 2023 and Aug 22, 2023 — classified as 1 malfunction.

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

Recent adverse event reports

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

• MalfunctionAug 22, 2023Deformation Due to Compressive Stress; Deformation Due to Compressive Stress

  IT WAS REPORTED DURING INSERTION, THE CLINICIAN WAS ABLE TO INSERT THE CATHETER 27CM INTO THE VASCULATURE, WITH 25CM EXTERNAL. CLINICIAN HAD GREAT BLOOD RETURN, BUT COULD NOT FLUSH THE CATHETER. SHE COULD INSERT THE CATHETER FURTHER, BUT COULD NOT RETRACT IT. CLINICIAN TRIED OTHER TECHNIQUES TO REMOVE THE CATHETER, BUT ULTIMATELY CALLED AN IR PHYSICIAN TO THE BEDSIDE, WHO WAS ABLE REMOVE THE INTRODUCER SHEATH AND THE CATHETER TOGETHER. WHEN THE CATHETER WAS REMOVED, CLINICIAN OBSERVED A KINK IN IT AT AROUND THE 15CM MARK. THE PATIENT'S CONDITION IS REPORTED AS FINE. ADDITIONAL INFORMATION RECEIVED REPORTED THE PATIENT HAD A DEEP VEIN THROMBOSIS (DVT) IN THE RIGHT CEPHALIC VEIN NEAR THE SHOULDER, WHERE IT MEETS THE AXILLARY VEIN. THE RIGHT CEPHALIC VEIN WAS THE VEIN INVOLVED WITH THE INITIAL PICC INSERTION THAT WAS UNSUCCESSFUL. AN ULTRASOUND OF THE UPPER RIGHT ARM WAS INITIATED AFTER SWELLING WAS OBSERVED, POST UNSUCCESSFUL PICC PLACEMENT/REMOVAL. PATIENT HAD BEEN ON ANTICOAGULATION THERAPY PRIOR TO PICC PLACEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17597481 ↗

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