ARROW IPN030771Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 30801902125959), received between Jun 22, 2023 and Nov 7, 2024 — classified as 2 injuries, 9 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (4 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 7, 2024Material Twisted/Bent; Unintended Movement; Material Twisted/Bent; Unintended Movement

  IT WAS REPORTED "THE WIRE OF THE PRODUCT IS VERY LIGHT AND CANNOT BE CONTROLLED (MOVES IN WRONG DIRECTIONS) DURING INSERTION INTO THE ARTERY." ADDITIONAL INFORMATION REPORTS, "THE GUIDEWIRE IS EASILY KINKING DURING THE INSERTION." THE USER CHANGED TO A NEW SET. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "UNKNOWN". ADDITIONAL INFORMATION WAS REQUESTED FROM THE CUSTOMER; HOWEVER, FURTHER DETAILS HAVE NOT BEEN PROVIDED AT THIS TIME.

  Patient problems: Insufficient Information

  MAUDE report 20629523 ↗
• MalfunctionJun 10, 2024Material Twisted/Bent; Physical Resistance/Sticking; Material Twisted/Bent; Physical Resistance/Sticking

  IT WAS REPORTED THAT: "THE PROBLEM IS THE METAL GUIDEWIRE, WHICH BENDS SEVERAL TIMES AFTER BEING INSERTED INTO THE CENTRAL CATHETER AND DESTROYS THE CATHETER. WE CANNOT WITHDRAW IT UNTIL AFTER THE CATHETER IS WITHDRAWN AND IT RUPTURES." THERE WAS NO REPORTED PATIENT HARM OR CONSEQUENCE. ASSOCIATED COMPLAINTS 3006425876-2024-00576.

  Patient problems: Insufficient Information

  MAUDE report 19496642 ↗
• MalfunctionJun 7, 2024Unraveled Material; Material Twisted/Bent; Physical Resistance/Sticking; Unraveled Material; Material Twisted/Bent; Physical Resistance/Sticking

  IT WAS REPORTED THAT: "THE PROBLEM IS THE METAL GUIDEWIRE, WHICH BENDS SEVERAL TIMES AFTER BEING INSERTED INTO THE CENTRAL CATHETER AND DESTROYS THE CATHETER. WE CANNOT WITHDRAW IT UNTIL AFTER THE CATHETER IS WITHDRAWN AND IT RUPTURES." THERE WAS NO REPORTED PATIENT HARM OR CONSEQUENCE. ASSOCIATED COMPLAINTS (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19482294 ↗
• MalfunctionMay 14, 2024Unraveled Material; Physical Resistance/Sticking; Unraveled Material; Physical Resistance/Sticking

  IT WAS REPORTED THAT "THE SWG GOT STUCK IN THE NEEDLE DURING INSERTION. UNABLE TO REMOVE THE SWG FROM THE NEEDLE. NEEDLE REMOVED WITH THE SWG AND NEW KIT OPENED." THE RETURNED DEVICE WAS UNRAVELED. THE PATIENTS CURRENT CONDITION IS REPORTED AS "DECEASED" BUT THERE WAS NO REPROTED PATIENT HARM OR CONSEQUENCE FROM THE REPORTED INCIDENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19309805 ↗
• MalfunctionMar 8, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT: IN VIEW OF A TRANSFER TO A DIFFERENT HOSPITAL DEPARTMENT IN THE NEXT FEW DAYS, THE NUMBER OF LINES HAD TO BE REDUCED, SO ONE OF THE LINES HAD TO BE CLAMPED AND HEPARINIZED. AT THE TIME OF TREATMENT, THE NURSE WANTED TO REMOVE THE INFUSION LINE TO CLOSE THE LINE. WHEN SHE TRIED TO UNSCREW THE LINE FROM THE EXTENSION WITH TAP, THE JUNCTION BROKE. CONSEQUENCES CONFIRMED: LINE WAS IMPOSSIBLE TO USE. LINE WAS CLAMPED. THE PATIENT WAS REPORTED AS FINE, THERE WAS NO REPORTED PATIENT HARM OR CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18865960 ↗
• MalfunctionMar 7, 2024Break; Fluid/Blood Leak; Break; Fluid/Blood Leak

  IT WAS REPORTED THAT: ON THE RIGHT JUGULAR CENTRAL VENOUS LINE, THE EXTENSION HUB OF THE DISTAL LINE BROKE (BROWN CONNECTOR). IT WAS DISCOVERED BECAUSE A LEAK WAS NOTED ON THIS LINE. THIS LINE WAS PERFUSED WITH G5% + MGSO4, CATHETER WAS DISINFECTED WITH UNCOLORED CHLORHEXIDINE. DISTAL LINE CLAMPED. PATIENT WAS REPORTED AS FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18854756 ↗
• InjuryFeb 8, 2024Crack; Fluid/Blood Leak; Crack; Fluid/Blood Leak

  IT WAS REPORTED THAT: THE LUER HUB/EXTENSION CORD FROM ANOTHER SUPPLIER CONNECTED TO THE EXTENSION LINE / CATHETER FROM TELEFLEX, CRACKED. A NOREPINEPHRINE LEAK APPEARED, WITH VENOUS RETURN IN THE PROXIMAL LINE. THE CONSEQUENCE WAS A SEVERE HYPOTENSION OF THE PATIENT. TREATMENT WAS THEN INFUSED VIA ANOTHER LINE. THE EXTENSION CORD WAS CHANGED.

  Patient problems: Low Blood Pressure/ Hypotension

  MAUDE report 18667422 ↗
• MalfunctionJan 26, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT: THE NURSE OBSERVED SOME BLOOD UNDER THE DRESSING. THE LEAK CAME FROM THE LUER HUB (MALE TIP) THAT WAS BROKEN ON THE DISTAL PORT OF THE CENTRAL CATHETER (FEMALE TIP). CLINICAL CONSEQUENCES: THE CVC WAS REMOVED.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 18590485 ↗
• InjuryJan 26, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT: THE NURSE OBSERVED A LEAK ON THE CVC BETWEEN THE PROXIMAL LINE AND THE LUER HUB. THE LEAK WAS DISCOVERED BECAUSE THE PATIENT PRESENTED HYPOTENSION DESPITE GIVING NORADRENALINE. THE NORADRENALINE WAS DELIVERED ON THE MEDIAL LINE, UNTIL THE CVC COULD BE CHANGED. ADDITIONAL INFORMATION: THE PATIENT EXPERIENCED LOW BLOOD PRESSURE FOR A FEW MINUTES BEFORE IT RETURNED TO NORMAL.

  Patient problems: Low Blood Pressure/ Hypotension

  MAUDE report 18590165 ↗
• MalfunctionJan 16, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT: A SLIGHT FLOW OF BLOOD VISIBLE BETWEEN THE DISTAL LINE OF THE CENTRAL CATHETER AND THE LUER HUB. THIS INCIDENT IS DUE TO A POOR CONNECTION OF THE LUER HUB WITH THE DISTAL LINE OF THE CATHETER. THE NURSE THEREFORE CLAMPED THE DISTAL PORT AND TOOK THE 2 ENDS AND THAT'S WHEN THE EXTENSION LINE DISCONNECTED, LEAVING THE LUER HUB (MALE TIP) IN THE DISTAL PORT OF THE CATHETER (FEMALE TIP). ADDITIONAL INFORMATION: THE LEAK WAS FOUND DURING A TRANSFUSION, THERE WAS NO LEAK BEFORE THAT. THE REPORTER IMMEDIATELY CLAMPED AND THEN UNDID THE DRESSING. THE TIP OF THE EXTENSION BROKE AND REMAINED IN THE TIP OF THE PORT (IMPOSSIBLE TO UNSCREW IT). SO, THEY REMOVED THE CVC. THERE WERE NO CLINICAL CONSEQUENCES FOR THE PATIENT. THEY WERE REPORTED AS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18516961 ↗
• MalfunctionJun 22, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT: THE WHITE LEUR HUB SEPARATED FROM THE DEVICE WHEN CHANGING THE DRESSING. THE PROXIMAL CHANNEL WAS CLAMPED, AND THE CATHETER WAS CHANGED. THERE WAS NO NEGATIVE CLINICAL CONSEQUENCE FOR THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17180490 ↗

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-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-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-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-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-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-0650-2018 · Oct 17, 2017 · Terminated
  Multi Lumen Central Venous Catheterization Kit; Product Code: ASK-12703-HH2; 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

…and 9 more.