ARROW IPN036755Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 80801902123745), received between Jul 9, 2020 and Nov 2, 2023 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Difficult to Flush” (1 report).

10 other recalls cover devices cleared under the same FDA submission (K121941); 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 2, 2023Difficult to Flush; Obstruction of Flow; Difficult to Flush; Obstruction of Flow

  IT WAS REPORTED THAT: THE PICC STOPPED DRAWING BLOOD AND STOPPED FLUSHING. THE ISSUE WAS IDENTIFIED DURING USE ON PATIENT. THERE WAS NO REPORTED PATIENT HARM OR CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18056680 ↗
• MalfunctionJul 9, 2020Entrapment of Device; Failure to Advance

  BEFORE A PICC INSERTION, THE NURSE TRIMMED THE CATHETER TO A MEASUREMENT OF 43 CM. DURING THE PROCESS, THE NURSE PULLED THE SENSOR BACK A LITTLE TO PREVENT DAMAGING THE FORMER ONE DURING THE SETUP OF THE CATHETER. AFTER THE CATHETER WAS TRIMMED, THE NURSE HAD TROUBLE ADVANCING THE SENSOR GETTING STUCK INSIDE THE CATHETER. THE NURSE DECIDED TO USE ANOTHER PICC KIT AND RESTART THE PROCESS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10249978 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K121941. One submission often covers many models, so check the product and lot details in each record.

• Z-2591-2023 · Aug 10, 2023 · Open, Classified
  Arrow ErgoPack, Pressure Injectable Two-Lumen PICC pre-loaded with Arrow VPS Stylet, REF CDC-35552-VPS; Catheter: Percutaneous, implanted, long-term intravascular catheter
• Z-0690-2018 · Oct 17, 2017 · Terminated
  ARROW PICC powered by ARROW VPS Stylet
• Z-0601-2018 · Jul 25, 2017 · Terminated
  ARROW PICC powered by ARROW VPS Stylet, Product Codes: CDC-35052-VPS and CDC-35041-VPS. Peripherally Inserted Central Catheter
• Z-0180-2018 · Jun 1, 2017 · Terminated
  ARROW PICC powered by ARROW VPS Stylet The Pressure Injectable PICC is indicated for short or long term peripheral access to the central venous system for intravenous therapy, bloo
• Z-0181-2018 · Jun 1, 2017 · Terminated
  ARROW PICC powered by ARROW VPS Stylet The Pressure Injectable PICC is indicated for short or long term peripheral access to the central venous system for intravenous therapy, bloo
• Z-0207-2016 · Oct 16, 2015 · Terminated
  ARROW PICC Kit featuring Chlorag+ard Technology Midline Catheterization Kit ARROW Advantage5 Pressure Injectable PICC Kit Arrow Pressure Injectable Arrow PICC powered by Arrow VPS
• Z-2462-2015 · Jul 30, 2015 · Terminated
  PICC Kits with Peel-Away Sheath Component; catheter, intravascular, therapeutic, ultrasound Product Usage: catheter, intravascular, therapeutic, ultrasound
• Z-2489-2015 · Jul 30, 2015 · Terminated
  Arrow International, Inc. PICC Kits and VPS Access Kits with Touhy Borst Component Catheter, Intravascular, Therapeutic, Ultrasound, Long Term Greater than 30 Days
• Z-1030-2015 · Jan 9, 2015 · Terminated
  Arrow Select Kits (ASK), Maximal Barrier Precautions Kits (CDC) and Arterial Catheterization Kit (NA) with Biopatch Dressing
• Z-1494-2014 · Mar 24, 2014 · Terminated
  Arrow Pressure Injectable PICC Powered by Arrow VPS Stylet Catalogue number CDC-35052-VPS, peripherally inserted central catheter.