ARROW IPN030893Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 10801902029291), received between May 27, 2021 and Nov 21, 2025 — classified as 12 malfunctions.

The most frequently reported specific device problem is “Material Separation” (5 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 18, 2026.

Most reported problems

Recent adverse event reports

The 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 21, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT "WHEN CHANGING THE CVC LINES, THE LINES WERE CLAMPED SO THAT THE OLD LINES COULD BE UNSCREWED AND REPLACED WITH NEW ONES. WHILE DOING THIS, ONE OF THE CATHETER HUBS BROKE OFF COMPLETELY." THE PATIENT'S CURRENT CONDITION IS REPORTED UNKNOWN AT THIS TIME.

  Patient problems: Insufficient Information

  MAUDE report 23617554 ↗
• MalfunctionApr 4, 2025Difficult to Remove; Difficult to Advance; Difficult to Remove; Difficult to Advance

  IT WAS REPORTED "DURING INSERTION THE GUIDE GOT STUCK IN THE PUNCTURE NEEDLE, IT WAS IMPOSSIBLE TO MOVE THE GUIDE, NEITHER ADVANCE OR REMOVE. THE CONSEQUENCE WAS A SLIGHT HEMATOMA. ANOTHER DEVICE WAS INSERTED." ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER STATES "THE GUIDE WAS DAMAGED DURING INSERTION. WE HAD TO PULL HARD TO LOOSEN IT AND UNSTUCK IT. AS A RESULT, A HEMATOMA APPEARED AT THE PUNCTURE SITE, MAKING IT IMPOSSIBLE TO INSERT THE CENTRAL LINE THERE. ANOTHER PUNCTURE SITE WITH ANOTHER CATHETER WAS USED, WITH SUCCESS. THE PATIENT WAS DISCHARGED HOME. CLINICAL MONITORING OF HEMATOMA". THERE WAS NO MEDICAL INTERVENTION REQUIRED. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE".

  Patient problems: Hematoma

  MAUDE report 21773452 ↗
• MalfunctionFeb 12, 2025Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED THAT "AFTER INSERTION OF THE CVC, 2 OUT OF 4 EXTENSION LINES WERE NOT WORKING: IT WAS IMPOSSIBLE TO ASPIRATE THE LINE. CVC CHANGED".

  Patient problems: Insufficient Information

  MAUDE report 21364552 ↗
• MalfunctionJan 14, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT WHEN A CATHETER WAS INSERTED, THE WINGS BROKE, AT THE MOMENT OF ATTACHING IT TO THE PATIENT. A SECOND CATHETER FROM THE SAME LOT NUMBER WAS USED, AND THE SAME INCIDENT OCCURRED. A THIRD CATHETER FROM A DIFFERENT LOT NUMBER WAS USED SUCCESSFULLY. THE PATIENT REQUIRED THREE CATHETER INSERTIONS IN A ROW, DURING WHICH THE LOCAL ANAESTHETIC WAS NO LONGER WORKING, AND CAUSING LOSS OF TIME. IT WAS ALSO OBSERVED THAT THE WINGS ARE ALREADY "CUT" IN THE PACKAGING ON ALL FOR THE AFFECTED LOT. THE ASSOCIATED EMDR REPORT NUMBERS ARE 3006425876-2025-00092, 3006425876-2025-00093 AND 3006425876-2025-00094.

  Patient problems: Insufficient Information

  MAUDE report 21149349 ↗
• MalfunctionJan 14, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT WHEN A CATHETER WAS INSERTED, THE WINGS BROKE, AT THE MOMENT OF ATTACHING IT TO THE PATIENT. A SECOND CATHETER FROM THE SAME LOT NUMBER WAS USED, AND THE SAME INCIDENT OCCURRED. A THIRD CATHETER FROM A DIFFERENT LOT NUMBER WAS USED SUCCESSFULLY. THE PATIENT REQUIRED THREE CATHETER INSERTIONS IN A ROW, DURING WHICH THE LOCAL ANAESTHETIC WAS NO LONGER WORKING, AND CAUSING LOSS OF TIME. IT WAS ALSO OBSERVED THAT THE WINGS ARE ALREADY "CUT" IN THE PACKAGING ON ALL FOR THE AFFECTED LOT. THE ASSOCIATED EMDR REPORT NUMBERS ARE 3006425876-2025-00092, 3006425876-2025-00093 AND 3006425876-2025-00094.

  Patient problems: Insufficient Information

  MAUDE report 21149181 ↗
• MalfunctionJan 14, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT WHEN A CATHETER WAS INSERTED, THE WINGS BROKE, AT THE MOMENT OF ATTACHING IT TO THE PATIENT. A SECOND CATHETER FROM THE SAME LOT NUMBER WAS USED, AND THE SAME INCIDENT OCCURRED. A THIRD CATHETER FROM A DIFFERENT LOT NUMBER WAS USED SUCCESSFULLY. THE PATIENT REQUIRED THREE CATHETER INSERTIONS IN A ROW, DURING WHICH THE LOCAL ANAESTHETIC WAS NO LONGER WORKING, AND CAUSING LOSS OF TIME. IT WAS ALSO OBSERVED THAT THE WINGS ARE ALREADY "CUT" IN THE PACKAGING ON ALL FOR THE AFFECTED LOT. THE ASSOCIATED EMDR REPORT NUMBERS ARE 3006425876-2025-00092, 3006425876-2025-00093 AND 3006425876-2025-00094.

  Patient problems: Insufficient Information

  MAUDE report 21149129 ↗
• MalfunctionMay 21, 2024Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT: "WHEN INSERTING THE VENOUS LINE, THE GUIDE BENT AND TWISTED AS THE CATHETER WAS BEING INSERTED". THERE WAS NO REPORTED PATIENT HARM. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19357162 ↗
• MalfunctionMay 1, 2024Crack; Material Separation; Crack; Material Separation

  IT WAS REPORTED "THE CATHETER'S FIXATION WINGS CRACKED FEW DAYS AFTER INSERTION. THE CATHETER WAS THEREFORE ATTACHED ON ONE SIDE ONLY." THE PATIENT'S CURRENT CONDITION IS REPORTED AS "UNKNOWN". ADDITIONAL INFORMATION WAS REQUESTED, NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

  Patient problems: Insufficient Information

  MAUDE report 19220091 ↗
• MalfunctionJun 24, 2022Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THE NURSE FOUND THE SEDATION ACCESS OF THE CENTRAL LINE PROXIMAL TO THE CATHETER WAS LEAKING. IT WAS REPORTED IT WAS UNKNOWN HOW LONG THE ACCESS HAD BEEN PUNCTURED, BUT THE PATIENT HAD BEEN UNEXPECTEDLY HYPERTENSIVE FOR THE LAST FEW DAYS. A NEW CATHETER WAS PLACED. NO PATIENT INJURY WAS REPORTED. THE PATIENT'S CONDITION WAS REPORTED AS FINE.

  Patient problems: High Blood Pressure/ Hypertension

  MAUDE report 14804533 ↗
• MalfunctionOct 5, 2021Deformation Due to Compressive Stress; Deformation Due to Compressive Stress

  THE COMPLAINT IS REPORTED AS: "THE CVC WAS INSERTED FOR 1 WEEK WHEN THE LINE INFUSING AMINES KINKED REGULARLY. WE UN-KINKED IT IMMEDIATELY IN ORDER TO GET THE PATIENT STABILIZED. THIS LINE WAS "SOFT" AND KINKED WHEREAS WE USE THESE DEVICES DAILY AND WE USUALLY DON'T HAVE ISSUE." IT WAS REPORTED THERE WAS NO SERIOUS CONSEQUENCE FOR THE PATIENT. THE PATIENT "HAD A HYPOTENSION WHICH WAS REVERSIBLE AFTER UNKINKING THE LINE."

  Patient problems: Low Blood Pressure/ Hypotension

  MAUDE report 12576114 ↗
• MalfunctionMay 27, 2021Improper Flow or Infusion; Improper Flow or Infusion

  CUSTOMER REPORTED "THE CATHETER WAS INSERTED IN THE PATIENT. DURING THE BACKFLOW ON THE MEDIANE LINE, THE NURSE OBSERVED A WHITE BACKFLOW WHEREAS THE PROPOFOL (PROPOFOL IS WHITE) WAS INFUSED VIA THE DISTALE LINE." IT WAS ALSO REPORTED "PATIENT SEDATED BY PROPOFOL IN THE DISTAL LINE. ASPIRATION WITH THE SYRINGE ON THE MEDIAN LINE OF WHITE LIQUID WHAT LED US TO THINK OF REMINISCENT OF PROPOFOL. (NO PARENTERAL NUTRITION IN PROGRESS, PROPOFOL WAS THE ONLY SIMILAR THERAPY). 5CC ASPIRATED, WITHOUT BLOOD REFLUX, NO PARTICULAR PRESSURE AT REFLUX." NO PATIENT HARM WAS REPORTED. THE PATIENT REMAINED IN THE HOSPITAL AT THE TIME OF THIS REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11895009 ↗
• MalfunctionMay 27, 2021Inaccurate Flow Rate; Inaccurate Flow Rate

  CUSTOMER REPORTED "THE STAFF FACED AN INADEQUATE FLOW RATE WITH THIS DEVICE. DURING USE ON THE PATIENT. THIS PATIENT HAS AN UNSTABLE BLOOD PRESSURE." IT WAS ALSO REPORTED "THERE WERE SIGNIFICANT VARIATIONS IN BLOOD PRESSURE. APPEARS TO CORRELATE WITH MIDLINE THERAPY BOLUSES. PATIENT UNDER NICOTINAMIDE ADENINE DINUCLEOTIDE ON PROXIMAL LINE. INSTALLATION OF PERIPHERAL LINE FOR ADMINISTRATION OF NORADRENALINE IN ORDER TO ELIMINATE THE DOUBT: IN BLOOD PRESSURE VARIATIONS CONTINUED."

  Patient problems: Insufficient Information

  MAUDE report 11894876 ↗

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 s
• 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-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
• 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

…and 9 more.