ARROW IPN037428Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 30801902125386), received between Nov 15, 2023 and Nov 28, 2023 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Difficult to Remove” (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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 28, 2023Separation Problem; Separation Problem

  IT WAS REPORTED THAT: WHEN REMOVING PEEL AWAY SHEATH DURING PICC INSERTION, THE TAB BROKE OFF ONE SIDE OF THE SHEATH. THE REPORTED DEFECT WAS DETECTED DURING USE ON PATIENT. THE PATIENT CONDITION WAS REPORTED AS "FINE". NO PATIENT INJURY/CONSEQUENCE OR MEDICAL INTERVENTION REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18215126 ↗
• MalfunctionNov 20, 2023Difficult to Remove; Material Twisted/Bent; Difficult to Remove; Material Twisted/Bent

  IT WAS REPORTED THAT "RIGHT BASILIC VEIN EASILY ACCESSED, GUIDEWIRE WITH NO NOTED DEFECTS, THREADED WITHOUT DIFFICULTY THROUGH ACCESS NEEDLE. AFTER PLACING PEEL AWAY SHEATH, UNABLE TO REMOVE GUIDEWIRE. AFTER MANIPULATION AND PULLING BACK OF THE INTRODUCER AND REMOVING INNER CANNULA WAS ABLE TO REMOVE GUIDEWIRE AND NOTED LOOPING REMAINED IN THE WIRE". AS A RESULT, THE CATHETER WAS REMOVED AND A 2ND CATHETER WAS INSERTED IN THE SAME INSERTION SITE. NO PATIENT HARM OR INJURY. THE PATIENT STATUS IS REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18175733 ↗
• MalfunctionNov 15, 2023Material Separation; Material Deformation; Material Separation; Material Deformation

  IT WAS REPORTED THAT: THE TIP TRACKER STYLET SEPARATED FROM THE STEREOJACK CONNECTOR FOLLOWING UNSUCCESSFUL PICC PLACEMENT. WIRE IS NOTED TO HAVE A DEFORMITY AND WAS VERY DIFFICULT TO REMOVE FROM THE PICC PRIOR TO SEPARATION. ADDITIONAL INFORMATION: THE ISSUE WAS IDENTIFIED DURING USE. NO MEDICAL INTERVENTION WAS NEEDED AND THE PATIENT DID NOT EXPERIENCE ANY SIGNS OR SYMPTOMS

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18140412 ↗

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