ARROW IPN055166Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10801902153743), received between Sep 13, 2021 and May 3, 2023 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Physical Resistance/Sticking” (2 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 3, 2023Deformation Due to Compressive Stress; Physical Resistance/Sticking; Deformation Due to Compressive Stress; Physical Resistance/Sticking

  THE COMPLAINT IS REPORTED AS: "UNPROBLEMATIC PUNCTURE OF THE RIGHT INTERNAL JUGULAR VEIN UNDER SONOGRAPHIC CONTROL, BLOOD ASPIRABLE, WIRE ADVANCEMENT, RESISTANCE AT THE NEEDLE TIP OR JUST BEHIND IT. RESISTANCE AT NEEDLE TIP OR JUST BEHIND, SONOGRAPHICALLY NEEDLE TIP UNDER VEIN, CAREFUL RETRACTION OF WIRE, RESISTANCE, STOP, NEEDLE AND WIRE REMOVED, NOW GOES EASILY THROUGH NEEDLE RETRACTION, WIRE TIP IS NOTED AS SLIGHTLY DEFORMED BUT IS ASSESSED AS IRRELEVANT ALTOGETHER, NEW PUNCTURE/WIRE ADVANCE/DILATOR/CATHETER ADVANCE OVER WIRE, ALL WITHOUT PROBLEMS, WHEN ATTEMPTING TO RETRACT WIRE OVER CATHETER, WIRE STRETCHES WITH SPRINGY RESISTANCE, WIRE AND CATHETER ARE SONOGRAPHICALLY IN VESSEL. SONOGRAPHICALLY IN THE VESSEL, ASPIRATION OF BLOOD THROUGH THE MEDIAL LUMEN, ADVANCEMENT OF A NEW WIRE INTO THE LUMEN TO GAIN ACCESS TO THE VESSEL, ATTEMPT TO WITHDRAW THE CATHETER WITH THE DEFECTIVE WIRE INSIDE ATTEMPT TO WITHDRAW THE CATHETER WITH THE DEFECTIVE WIRE INSIDE BUT AGAIN SPRINGY RESISTANCE, REMOVAL OF THE CATHETER WITH THE NEW WIRE IN PLACE, THE WINDING OF THE FIRST WIRE REMAINS IN THE CHILD, SEVERAL CAREFUL ATTEMPTS TO RETRACT WITH AND ROTATION OF THE WIRE ARE UNSUCCESSFUL, SURGICAL DIS

  Patient problems: Insufficient Information

  MAUDE report 16861938 ↗
• InjuryMay 3, 2023Entrapment of Device; Unraveled Material; Physical Resistance/Sticking; Entrapment of Device; Unraveled Material; Physical Resistance/Sticking

  THE COMPLAINT IS REPORTED AS: "UNPROBLEMATIC PUNCTURE OF THE RIGHT INTERNAL JUGULAR VEIN UNDER SONOGRAPHIC CONTROL, BLOOD ASPIRABLE, WIRE ADVANCEMENT, RESISTANCE AT THE NEEDLE TIP OR JUST BEHIND IT. RESISTANCE AT NEEDLE TIP OR JUST BEHIND, SONOGRAPHICALLY NEEDLE TIP UNDER VEIN, CAREFUL RETRACTION OF WIRE, RESISTANCE, STOP, NEEDLE AND WIRE REMOVED, NOW GOES EASILY THROUGH NEEDLE RETRACTION, WIRE TIP IS NOTED AS SLIGHTLY DEFORMED BUT IS ASSESSED AS IRRELEVANT ALTOGETHER, NEW PUNCTURE/WIRE ADVANCE/DILATOR/CATHETER ADVANCE OVER WIRE, ALL WITHOUT PROBLEMS, WHEN ATTEMPTING TO RETRACT WIRE OVER CATHETER, WIRE STRETCHES WITH SPRINGY RESISTANCE, WIRE AND CATHETER ARE SONOGRAPHICALLY IN VESSEL. SONOGRAPHICALLY IN THE VESSEL, ASPIRATION OF BLOOD THROUGH THE MEDIAL LUMEN, ADVANCEMENT OF A NEW WIRE INTO THE LUMEN TO GAIN ACCESS TO THE VESSEL, ATTEMPT TO WITHDRAW THE CATHETER WITH THE DEFECTIVE WIRE INSIDE ATTEMPT TO WITHDRAW THE CATHETER WITH THE DEFECTIVE WIRE INSIDE BUT AGAIN SPRINGY RESISTANCE, REMOVAL OF THE CATHETER WITH THE NEW WIRE IN PLACE, THE WINDING OF THE FIRST WIRE REMAINS IN THE CHILD, SEVERAL CAREFUL ATTEMPTS TO RETRACT WITH AND ROTATION OF THE WIRE ARE UNSUCCESSFUL, SURGICAL DIS

  Patient problems: Foreign Body In Patient

  MAUDE report 16861769 ↗
• MalfunctionSep 13, 2021Migration or Expulsion of Device; Migration or Expulsion of Device

  THE COMPLAINT IS REPORTED AS: "INCIDENT HAPPENED ON (B)(6) 2021. WHEN THE DOCTOR REMOVED THE OPERATING-THEATRE DRAPES, THE CATHETER SLIDED THROUGH THE JUNCTURE HUB WINGS AND THUS THE CATHETER CAME OUT OF THE PATIENT AT THE INSERTION POINT." IT WAS REPORTED THERE WAS NO SERIOUS CONSEQUENCE FOR THE PATIENT. ANOTHER CATHETER WAS INSERTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12464728 ↗

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-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-1119-2019 · Jan 10, 2019 · Terminated
  Arrow Two-Lumen Central Venous Catheterization Set with Blue FlexTip Catheter Product Code: CD-10802 GTN: 00801902015396
• 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-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-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-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-1967-2018 · Apr 11, 2018 · Terminated
  Maximal Barrier Drape; Product Code: ASK-04000-HMC
• 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-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-0650-2018 · Oct 17, 2017 · Terminated
  Multi Lumen Central Venous Catheterization Kit; Product Code: ASK-12703-HH2; Exp. Dates Feb 2018 - Nov 2018
• Z-0657-2018 · Oct 17, 2017 · Terminated
  Central Venous Catheterization Kit with Blue FlexTip Catheter; Product code: AK-04301; 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-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

…and 9 more.