ARROW IPN037427Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 30801902125379), received between Oct 10, 2023 and Dec 22, 2023 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Break” (3 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 22, 2023Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT: AFTER THE PEEL AWAY SHEATH WAS PLACED, THE RN WAS UNABLE TO REMOVE THE PEEL AWAY SHEATH WITHOUT RETRACING THE SHEATH A BIT. ONCE RETRACTED , THE GUIDEWIRE WAS REMOVED AND NOTED TO BE BENT. 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 18381936 ↗
• MalfunctionDec 19, 2023Fluid/Blood Leak; Material Puncture/Hole; Fluid/Blood Leak; Material Puncture/Hole

  IT WAS REPORTED THAT: WE HAD A PATIENT COME INTO THE ER WITH A LEAKING PICC AND AFTER ASSESSMENT IT WAS NOTED TO HAVE A PIN HOLE IN THE EXTENSION BETWEEN THE HUB OF THE STABILIZATION PART OF THE PICC WHERE THE CLAMP IS. WE HAD TO SCHEDULE THE PATIENT TO HAVE THE LINE REPLACED FOR CONTINUED TREATMENT. 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 18357975 ↗
• MalfunctionOct 10, 2023Break; Break

  IT WAS REPORTED THE GLIDE-THRU SHEATH WAS DIFFICULT TO REMOVE FROM THE PATIENT. THE PEEL TABS WOULD NOT PEEL APART, AND ONE TAB ENDED UP BREAKING OFF. THERE WAS NO HARM TO THE PATIENT. THE PATIENT'S CONDITION IS REPORTED AS FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17905322 ↗
• MalfunctionOct 10, 2023Break; Difficult or Delayed Separation; Break; Difficult or Delayed Separation

  IT WAS REPORTED THE CLINICIAN HAD DIFFICULTY PEELING THE SHEATH APART. ONE TAB BROKE OFF AFTER PULLING SO HARD. NO PATIENT HARM WAS REPORTED AND THE PICC WAS SUCCESSFULLY PLACED. THE SHEATH WAS REMOVED FROM THE PATIENT IN ITS ENTIRETY. THE PATIENT'S CONDITION IS REPORTED AS FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17904628 ↗
• MalfunctionOct 10, 2023Break; Material Separation; Difficult or Delayed Separation; Break; Material Separation; Difficult or Delayed Separation

  IT WAS REPORTED THE CLINICIAN HAD DIFFICULTY PEELING THE SHEATH APART. ONE TAB BROKE OFF AFTER PULLING SO HARD. NO PATIENT HARM WAS REPORTED AND THE PICC WAS SUCCESSFULLY PLACED. THE SHEATH WAS REMOVED FROM THE PATIENT IN ITS ENTIRETY. THE PATIENT'S CONDITION IS REPORTED AS FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17904579 ↗

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-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