ARROW IPN911881Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10801902134988), received between Feb 25, 2021 and Jul 3, 2023 — classified as 1 injury, 6 malfunctions.

The most frequently reported specific device problem is “Component Misassembled” (3 reports).

8 other recalls cover devices cleared under the same FDA submission (K153487); 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 3, 2023Component Misassembled; Component Misassembled

  THE COMPLAINT IS REPORTED AS: "DURING THE PROCEDURE, THE NURSE ACCESSED THE VEIN AND INSERTED THE 4.5 FRENCH GLIDE THRU PEEL-AWAY SHEATH. WHEN SHE PICKED UP THE CATHETER TO INSERT IT THROUGH THE SHEATH, SHE FOUND A DOUBLE LUMEN 5.5 FRENCH PICC INCLUDED INSTEAD OF A SINGLE LUMEN PICC." A NEW KIT WAS OPENED TO COMPLETE THE PROCEDURE. NO PATIENT HARM REPORTED. THE PATIENT'S CONDITION IS REPORTED AS FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17249723 ↗
• MalfunctionJun 26, 2023Wrong Label; Wrong Label

  THE COMPLAINT IS REPORTED AS: "DURING THE PROCEDURE, THE NURSE ACCESSED THE VEIN WITH THE NEEDLE AND WAS PREPARING TO INSERT THE GLIDE THRU PEEL-AWAY SHEATH THEN THE PICC. WHEN SHE PICKED UP THE SHEATH, IT WAS THE INCORRECT SIZE (5.5 FRENCH.) THE CATHETER WAS ALSO INCORRECT: THERE WAS A 5.5 FRENCH DOUBLE LUMEN INSTEAD OF A 4.5 FRENCH SINGLE LUMEN CATHETER. THE PROCEDURE WAS DELAYED AS A NEW KIT HAD TO BE OPENED." NO PATIENT HARM WAS REPORTED. THE PATIENT'S CONDITION IS REPORTED AS FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17197949 ↗
• MalfunctionJun 26, 2023Component Misassembled; Component Misassembled

  THE COMPLAINT IS REPORTED AS: "DURING THE PROCEDURE, THE NURSE ACCESSED THE VEIN AND INSERTED THE 4.5 FRENCH GLIDE THRU PEEL-AWAY SHEATH. WHEN SHE PICKED UP THE CATHETER TO INSERT IT THROUGH THE SHEATH, SHE FOUND A DOUBLE LUMEN 5.5 FRENCH PICC INCLUDED INSTEAD OF A SINGLE LUMEN PICC. SHE DID NOT HAVE ANOTHER KIT ON HER CART. SHE HAD TO STAY WITH HER PATIENT FOR OVER 30 MINUTES WITH THE PROCEDURE 1/2 WAY DONE AND WAIT FOR ANOTHER NURSE TO GET A CATHETER TO HER." NO PATIENT HARM WAS REPORTED. THE PATIENT'S CONDITION IS REPORTED AS FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17197848 ↗
• MalfunctionJun 12, 2023Component Misassembled; Component Misassembled

  IT WAS REPORTED THAT: UPON OPENING THE KIT, THE NURSE FOUND A DOUBLE LUMEN PICC INCLUDED INSTEAD OF A SINGLE LUMEN PICC. ANOTHER KIT HAD TO BE OPENED. THE ISSUE WAS FOUND PRIOR TO USE ON PATIENT. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17107668 ↗
• MalfunctionFeb 22, 2022Deformation Due to Compressive Stress; Deformation Due to Compressive Stress

  CUSTOMER REPORTED THE SPRING WIRE GUIDE UNRAVELED. NO PATIENT HARM REPORTED. THE PATIENT'S CONDITION IS REPORTED AS FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13580634 ↗
• InjuryJul 8, 2021Material Separation; Material Separation

  THE COMPLAINT IS REPORTED AS: CUSTOMER REPORTED PICC BROKE/SEPARATED FROM HUB. PATIENT CAME IN TO GET THE CATHETER REMOVED VIA SURGERY AND HAD ANOTHER LINE PLACED. THE PATIENT'S CONDITION IS REPORTED AS FINE.

  Patient problems: Foreign Body In Patient

  MAUDE report 12135302 ↗
• MalfunctionFeb 25, 2021Break; Break

  DURING A PICC INSERTION, THE NURSE BEGAN TO PEEL AWAY THE GLIDETHRU SHEATH AND HALF OF THE TOP PORTION OF THE SHEATH BROKE OFF PREMATURELY. THE REST OF THE SHEATH REMAINED IN PLACE. NO PATIENT INJURY OR COMPLICATION REPORTED. THE PATIENT'S CONDITION IS REPORTED AS FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11382113 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K153487. One submission often covers many models, so check the product and lot details in each record.

• Z-0001-2024 · Aug 10, 2023 · Open, Classified
  Arrow ErgoPack, Pressure Injectable Arrowg+ard Blue Advance Two-Lumen PICC pre-loaded with Arrow VPS Precision Stylet, REF CDC-45552-VPS2; Catheter: Percutaneous Implanted Long-Ter
• Z-1807-2019 · Apr 23, 2019 · Terminated
  Arrowg+ard Blue Advance PICC pre loaded with Arrow VPS" Precision Stylet Product Code: CDC 44063 VPS2
• Z-1810-2019 · Apr 23, 2019 · Terminated
  Arrowg+ard Blue Advance PICC pre loaded with Arrow VPS" Precision Stylet Product Code: CDC 45063 VPS2
• Z-1808-2019 · Apr 23, 2019 · Terminated
  Arrowg+ard Blue Advance" PICC pre loaded with Arrow VPS" Precision Stylet Product Code: CDC 45041 VPS2
• Z-1365-2019 · Dec 13, 2018 · Terminated
  Arrow PICC powered by Arrow VPS Precision Stylet Product Code:CDC-45052-VPS2 Product Usage: The Arrow Pressure Injectable PICC is indicated for short-term or longterm peripheral a
• Z-1366-2019 · Dec 13, 2018 · Terminated
  Arrow PICC powered by Arrow VPS Precision Stylet Product Code:CDC-44052-VPS2 Product Usage: The Arrow Pressure Injectable PICC is indicated for short-term or longterm peripheral a
• Z-3199-2018 · Jul 17, 2018 · Terminated
  4.5 Fr x 40 cm single-lumen PICC Kit, Product Code CDC-44041-VPS2, 5.5 Fr double-lumen PICC Kit, Product Code CDC-44052-VPS2
• Z-3200-2018 · Jul 17, 2018 · Terminated
  5.5 Fr x 40 cm double-lumen PICC Kit, Product Code CDC-44052-VPS2