ARROW IPN036730Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 30801902123801), received between Mar 22, 2024 and Mar 22, 2024 — classified as 1 malfunction.

The most frequently reported specific device problem is “Physical Resistance/Sticking” (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 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.

• MalfunctionMar 22, 2024Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED "THE CLINICIAN WAS ABLE TO BREAK APART, PEEL-AWAY, & REMOVE THE SHEATH FROM THE INSERTION SITE, AFTER THE PICC WAS FULLY PLACED WITHOUT ISSUE, BUT EXPERIENCED A LITTLE RESISTANCE, REQUIRING MORE EFFORT TO BREAK IT APART" NO MEDICAL INTERVENTION REQUIRED. NO PATIENT HARM OR INJURY. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18962823 ↗

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-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-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-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.