ARROW IPN928814Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10801902217230), received between Jan 17, 2025 and Dec 22, 2025 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Component Missing” (2 reports).

11 other recalls cover devices cleared under the same FDA submission (K112896); 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 22, 2025Migration; Migration

  IT WAS REPORTED THAT "I JUST PLACED A DOUBLE LUMEN PICC LINE IN A PATIENT WITH 1 ARM TO USE. RN FLUSHED THE WHITE LUMEN PRIOR TO PULLING IT BACK, AND IT FELT "STICKY TO PULL BACK" BUT WAS ABLE TO PULL BACK, TRIM AND READVANCE. PICC WAS PLACED WITHOUT ISSUE, GOT A BULLSEYE. REMOVED THE DOPPLER WIRE IN THE PINK LUMEN AND FLUSHED WITH MICROCLAVE. TRIED TO REMOVE "BUDDY" WIRE THAT COMES IN THE PICC AND COULD NOT REMOVE IT. PULLED AGAIN ON THE BUDDY WIRE AND THE END OF THE PICC BETWEEN THE "0" MARK AND THE HUB FOLDED LIKE AN ACCORDION. PULLED THE WHITE LUMEN STRAIGHT. I GOT OUT A STIFF WIRE AND INSERTED IT IN THE WHITE LUMEN WHICH MOVED FREELY IN AND OUT OF THE CATHETER AND THEN I WAS ABLE TO REMOVE THE "BUDDY WIRE". IT SEEMED THAT IT WAS "STICKING" BETWEEN THE HUB AND THE "0" MARK. I HAD ALREADY BROKE AWAY WITH MY SHEATH AND THREW AWAY MY DOPPLER WIRE SO I HAD TO GET OUT A PIZZA BOX MEASURE THAT DOPPLER WIRE NEXT TO A STIFF WIRE AND TRY AND REINSERT THIS PIZZA BOX WIRE TO SEE IF I COULD GET ANOTHER BULLSEYE AFTER MANIPULATING THE PICC LINE. I COULD NOT GET THE PIZZA BOX WIRE TO THREAD ALL THE WAY, SO I ENDED UP REMOVING ALL WIRES AND GETTING AN CXR TO CONFIRM PLACEMENT. I HAD A BULLSEY

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23863733 ↗
• MalfunctionJan 17, 2025Component Missing; Component Missing

  IT WAS REPORTED THAT VENOUS ACCESS STAFF IDENTIFIED MULTIPLE DUAL LUMEN PICC KITS CONTAINING SINGLE LUMEN CATHETERS. THE ASSOCIATED EMDR REPORT NUMBERS ARE 9680794-2025-00013, 9680794-2025-00017 AND 9680794-2025-00016.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21179761 ↗
• MalfunctionJan 17, 2025Component Missing; Component Missing

  IT WAS REPORTED THAT VENOUS ACCESS STAFF IDENTIFIED MULTIPLE DUAL LUMEN PICC KITS CONTAINING SINGLE LUMEN CATHETERS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21179706 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K112896. One submission often covers many models, so check the product and lot details in each record.

• Z-2378-2026 · Apr 21, 2026 · Open, Classified
  Description/REF: PI PICC: 3: 6FR x 55CM w CHG/ DLX-35563-HPKC; AGBA PICC: 2L 5.5 FR X 45 CM/ASK-44552-ABKB; AGBA PICC/DELTA KIT: 5.5 FR X 55 CM/ASK-45552-MHBV; AGBA PICC: 1L 4.5FR
• Z-1822-2019 · Apr 23, 2019 · Terminated
  Arrow PICC with Chlorag+ard Technology Product Code:PR 45552 HPHNM
• Z-1820-2019 · Apr 23, 2019 · Terminated
  Arrow PICC with Chlorag+ard Technology Product Code:PR 45541 HPHNM
• Z-1819-2019 · Apr 23, 2019 · Terminated
  Arrow PICC with Chlorag+ard Technology Product Code: PR 45541 HPHNL
• Z-1811-2019 · Apr 23, 2019 · Terminated
  Arrowg+ard Blue Advance PICC Product Code: CDC45541HPK1A
• Z-1327-2018 · Dec 22, 2017 · Terminated
  Pressure Injectable ARROW(R) PICC Kit with Chlorag+ard Technology, Part Numbers: (1) ASK-45541-RWJ4; (2) ASK-45552-RWJ4
• Z-0996-2018 · Nov 27, 2017 · Terminated
  Pressure Injectable Multi- Lumen Central Venous Pressure Injectable ARROW(R) PICC Kit with Chlorag+ard(R) Technology Product Usage: The Arrow CVC is indicated to provide short-ter
• Z-2698-2017 · Jun 12, 2017 · Terminated
  Arrow EVOLUTION Pressure Injectable PICC with Chlorag+ard Antimicrobial and Antithrombogenic Technology
• Z-2331-2017 · May 9, 2017 · Terminated
  1) Pressure Injectable ARROW(R) PICC Kit with Chlorag+ard(R) Technology The Pressure Injectable PICC with Chlorag+ard Antimicrobial and Antithrombogenic Technology is indicated for
• Z-1705-2017 · Mar 3, 2017 · Terminated
  The CG+ Arrow PIC Catheters permit venous access to the central circulation through a peripheral vein.
• 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