ARROW IPN033083Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 30801929122979), received between Aug 6, 2021 and Dec 18, 2024 — classified as 1 injury, 3 malfunctions.

The most frequently reported specific device problem is “Material Twisted/Bent” (3 reports).

24 other recalls cover devices cleared under the same FDA submission (K862056); 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryDec 18, 2024Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT "DURING CVC INSERTION IN RIGHT FEMORAL ON 1 YEAR OLD BABY, IT WAS OBSERVED THAT THE SWG KINKED 90 DEGREES WHEN THE INTRODUCING THE DILATOR. THE SWG WAS ALREADY IN PLACE AND CONFIRMED VIA ECHOGRAPHY. THIS HAPPENED TWICE WITH THIS PATIENT ON THE SAME DAY WITH THE SAME LOT NUMBER. IT WAS NOT POSSIBLE TO REINSERT NEW CVC IN THE SAME INSERTION SITE AS HEMATOMA APPEARED. A NEW CVC WAS INSERTED IN THE LEFT FEMORAL. AS A RESULT, IT PROLONGED THE SEDATION TIME WITH HEMORRHAGIC AND INFECTION RISK FOR THE BABY".

  Patient problems: Hematoma

  MAUDE report 20964994 ↗
• MalfunctionDec 18, 2024Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT "DURING CVC INSERTION IN RIGHT FEMORAL ON 1 YEAR OLD BABY, IT WAS OBSERVED THAT THE SWG KINKED 90 DEGREES WHEN THE INTRODUCING THE DILATOR. THE SWG WAS ALREADY IN PLACE AND CONFIRMED VIA ECHOGRAPHY. THIS HAPPENED TWICE WITH THIS PATIENT ON THE SAME DAY WITH THE SAME LOT NUMBER. IT WAS NOT POSSIBLE TO REINSERT NEW CVC IN THE SAME INSERTION SITE AS HEMATOMA APPEARED. A NEW CVC WAS INSERTED IN THE LEFT FEMORAL. AS A RESULT, IT PROLONGED THE SEDATION TIME WITH HEMORRHAGIC AND INFECTION RISK FOR THE BABY".

  Patient problems: Hematoma

  MAUDE report 20964920 ↗
• MalfunctionMar 5, 2024Material Twisted/Bent; Physical Resistance/Sticking; Material Twisted/Bent; Physical Resistance/Sticking

  IT WAS REPORTED " A PEDIATRIC CVC WAS DFFICULT TO INSERTED INTO THE NEEDLE. THE GUIDE APPEARED TO STALL AND UNRAVELLED WHEN REMOVED. THE NEEDLE ASSOCIATED WITH THE GUIDE HAD TO BE REMOVED." A NEW GUIDE WAS INSERTED. NO MEDICAL INTERVENTION REQUIRED. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "STABLE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18838343 ↗
• MalfunctionAug 6, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  THE COMPLAINT IS REPORTED AS: THE ISSUE WITH THE PRODUCT WAS THAT ONE OF THE CATHETER LUMENS DISCONNECTED COMPLETELY FROM THE CENTRAL HUB OF THE CATHETER WHILE IN USE ON A PATIENT AND HAD TO BE REPLACED. THE LINE WAS INSERTED IN THE RIGHT FEMORAL ON (B)(6) 2021. THERE WERE TWO INOTROPES BEING INFUSED VIA THAT LUMEN AT THE TIME OF THE INCIDENT AND THERE WAS SEDATION RUNNING VIA THE OTHER LUMEN, ALL LUMENS WERE IN USE. THERAPY WAS DELAYED AS A RESULT OF THE INCIDENT WITHOUT HARM TO THE PATIENT. THERE WERE NO PATIENT COMPLICATIONS AS A NEW LINE WAS INSERTED BY THE PICU CONSULTANT. IT WAS REPORTED THE PATIENT HAD BEEN DISCHARGED FROM THE PICU TO THE WARD AT THE TIME OF THIS REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12291353 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K862056. One submission often covers many models, so check the product and lot details in each record.

• Z-2377-2026 · Apr 21, 2026 · Open, Classified
  Description/REF: ARTERIAL LINE KIT: SL 20 GA X 5 IN/ASK-04510-MM6 RA CATH KIT: 20 GA X 1-3/4IN/NA-04020-X1ASP ACCESS TRAY/ASK-04001-MS RA CATH KIT: 20 GA X 8 CM/ASK-00820-UM1 VESSE
• Z-1119-2019 · Jan 10, 2019 · Terminated
  Arrow Two-Lumen Central Venous Catheterization Set with Blue FlexTip Catheter Product Code: CD-10802 GTN: 00801902015396
• Z-1118-2019 · Jan 10, 2019 · Terminated
  Arrow Two-Lumen Central Venous Catheterization Kit with Blue FlexTip Catheter Product Code: AH-11802 (OUS) GTN: 00801902026132
• Z-0723-2019 · Nov 14, 2018 · Terminated
  Arrow CVC 2 Lumen, Pediatric Two-Lumen Central Venous Cauterization Set with Blue FlexTip Catheter, 4 Fr 2 Lumen 5cm, Reference # CS-12402 The Arrow CVC is intended to provide sho
• Z-2818-2018 · Jul 10, 2018 · Terminated
  HANDS-OFF Multi-Lumen Central Venous Catheter with Blue FlexTip for use only with Arrow One-Piece Percutaneous Sheath Introducer System, Material HO-14702 The central venous cathe
• Z-2819-2018 · Jul 10, 2018 · Terminated
  HANDS-OFF Multi-Lumen Central Venous Catheter with Blue FlexTip for use only with Arrow One-Piece Percutaneous Sheath Introducer System, Material HO-14703 The central venous cath
• Z-2336-2018 · May 11, 2018 · Terminated
  Multi-Lumen Central Venous Catheterization Set with Blue FlexTip Catheter, CS-15853-E Product CVCs are intended to permit venous access to the central circulation through a single
• Z-1982-2018 · Apr 11, 2018 · Terminated
  ARROWg+ard Blue(R) MAC(TM) Two-Lumen Central Venous Access Kit for use with 7-7.5 Fr. Catheters; Product Code: ASK-21142-WHC2
• Z-1978-2018 · Apr 11, 2018 · Terminated
  Two-Lumen Central Venous Catheterization Kit with Blue FlexTip(R) Catheter and Sharps Safety Features; Product Code: ASK-15402-HOP
• Z-1967-2018 · Apr 11, 2018 · Terminated
  Maximal Barrier Drape; Product Code: ASK-04000-HMC
• Z-1332-2018 · Dec 22, 2017 · Terminated
  (1) Access Tray, Part Number (PN): ASK-04001-MS; Arrow Multi-Lumen CVC Kit (2) PN: CDC-12703-1A; (3) PN: CDC-15703-1A; (4) PN: CDC-15703-B1A; Arrow Two-Lumen CVC Kit (5) PN: CDC-12
• Z-0654-2018 · Oct 17, 2017 · Terminated
  Arrow Multi Lumen CVC Kit (Central venous catheter); Product Code: CDC-15703-1A; Exp. Dates Feb 2018 - Nov 2018
• Z-0648-2018 · Oct 17, 2017 · Terminated
  Multi Lumen Central Venous Catheterization Kit with Blue FlexTip Catheter and Sharps Safety Features; Product Code: ASK 15703 NYP; Exp. Dates Feb 2018 - Nov 2018
• Z-0652-2018 · Oct 17, 2017 · Terminated
  Multi Lumen Central Venous Catheterization Kit with Blue FlexTip Catheter, Sharps Safety Features, and Maximal Barrier Precautions Features; Product Code: ASK-12703-WMC1; Exp. Dat
• Z-0650-2018 · Oct 17, 2017 · Terminated
  Multi Lumen Central Venous Catheterization Kit; Product Code: ASK-12703-HH2; Exp. Dates Feb 2018 - Nov 2018

…and 9 more.