ARROW IPN030078Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00801902102133), received between Dec 15, 2022 and Mar 21, 2025 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 21, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT "INITIALLY IT FLUSHED FINE BUT SUDDENLY THE BROWN PORT CRACKED AND STARTED LEAKING.". THE PATIENT HAD NO HARM OR INJURY.

  Patient problems: Insufficient Information

  MAUDE report 21663256 ↗
• MalfunctionSep 13, 2024Material Twisted/Bent; Material Twisted/Bent

  IT WAS INITIALLY REPORTED "THE DOCTOR FOUND THE SWG TIP KINKED DURING USE ON THE PATIENT. THEY CHANGED A NEW ONE. NO HARM FOR THE PATIENT." ADDITIONAL INFORMATION CLARIFIED, "THE CATHETER TIP WAS DAMAGED" INSTEAD. THERE WAS NO MEDICAL INTERVENTION REQUIRED. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20212195 ↗
• MalfunctionJan 26, 2024Crack; Crack

  IT WAS REPORTED THAT "DURING THE INSERTION OF THE CVC, THE PLASTIC HUB IS CRACKED, THE NEEDLE CANNOT BE USED. CLINICAL CONSEQUENCE: DELAY IN TREATMENT. KIT CHANGED." PATIENT CONDITION STABLE. THERE WAS NO OTHER PATIENT HARM OR CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18590646 ↗
• MalfunctionNov 14, 2023Deformation Due to Compressive Stress; Deformation Due to Compressive Stress

  IT WAS REPORTED THAT: A KINK WAS NOTED ON THE SWG PRIOR TO USE. ANOTHER DEVICE WAS USED INSTEAD. NO CONSEQUENCES FOR ANY PATIENTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18129519 ↗
• MalfunctionDec 15, 2022Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED THE NURSE WENT TO SAMPLE BLOOD FROM THE CATHETER THAT HAD BEEN INSERTED ON 28 OCTOBER AND FOUND THE PROXIMAL LINE WAS LEAKING. THE MEDIAL LINE HAD NO REFLUX (BLOCKAGE/OCCLUSION), AND THE DISTAL LINE WAS WRAPPED IN A BAND AND HAD AN ANTI-REFLUX CONNECTOR ON IT. THE BAND WAS REMOVED AND THE LINE WAS CHECKED. THERE WAS NO REFLUX BUT PRESENCE OF AIR AND LEAKS AND THE LINE HAD A HOLE IN IT. THE DISTAL LINE WAS IMMEDIATELY CLAMPED AND THE CATHETER WAS REMOVED. A CHEST X-RAY WAS PERFORMED. IT WAS REPORTED THERE WAS NO PATIENT INJURY AND NO MEDICAL INTERVENTION WAS REQUIRED. THE PATIENT'S CONDITION IS REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15991831 ↗
• MalfunctionDec 15, 2022Fluid/Blood Leak; Material Puncture/Hole; Fluid/Blood Leak; Material Puncture/Hole

  IT WAS REPORTED THE NURSE WENT TO SAMPLE BLOOD FROM THE CATHETER THAT HAD BEEN INSERTED ON 28 OCTOBER AND FOUND THE PROXIMAL LINE WAS LEAKING. THE MEDIAL LINE HAD NO REFLUX (BLOCKAGE/OCCLUSION), AND THE DISTAL LINE WAS WRAPPED IN A BAND AND HAD AN ANTI-REFLUX CONNECTOR ON IT. THE BAND WAS REMOVED AND THE LINE WAS CHECKED. THERE WAS NO REFLUX BUT PRESENCE OF AIR AND LEAKS AND THE LINE HAD A HOLE IN IT. THE DISTAL LINE WAS IMMEDIATELY CLAMPED AND THE CATHER WAS REMOVED. A CHEST X-RAY WAS PERFORMED. IT WAS REPORTED THERE WAS NO PATIENT INJURY AND NO MEDICAL INTERVENTION WAS REQUIRED. THE PATIENT'S CONDITION IS REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15991817 ↗
• MalfunctionDec 15, 2022Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THE NURSE WENT TO SAMPLE BLOOD FROM THE CATHETER THAT HAD BEEN INSERTED ON 28 OCTOBER AND FOUND THE PROXIMAL LINE WAS LEAKING. THE MEDIAL LINE HAD NO REFLUX (BLOCKAGE/OCCLUSION), AND THE DISTAL LINE WAS WRAPPED IN A BAND AND HAD AN ANTI-REFLUX CONNECTOR ON IT. THE BAND WAS REMOVED AND THE LINE WAS CHECKED. THERE WAS NO REFLUX BUT PRESENCE OF AIR AND LEAKS AND THE LINE HAD A HOLE IN IT. THE DISTAL LINE WAS IMMEDIATELY CLAMPED AND THE CATHER WAS REMOVED. A CHEST X-RAY WAS PERFORMED. IT WAS REPORTED THERE WAS NO PATIENT INJURY AND NO MEDICAL INTERVENTION WAS REQUIRED. THE PATIENT'S CONDITION IS REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15991670 ↗

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-1967-2018 · Apr 11, 2018 · Terminated
  Maximal Barrier Drape; Product Code: ASK-04000-HMC
• 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-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-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-0650-2018 · Oct 17, 2017 · Terminated
  Multi Lumen Central Venous Catheterization Kit; Product Code: ASK-12703-HH2; 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-0657-2018 · Oct 17, 2017 · Terminated
  Central Venous Catheterization Kit with Blue FlexTip Catheter; Product code: AK-04301; Exp. Dates Feb 2018 - Nov 2018

…and 9 more.