ARROW IPN030757 (REF CS-12854-E)Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00801902028983), received between Sep 29, 2023 and Aug 11, 2025 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Connection Problem” (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.

• MalfunctionAug 11, 2025Connection Problem; Connection Problem

  IT WAS REPORTED, "WHEN THE SHEATH IS PUSHED INTO THE VEIN, THE ACTUAL CANNULA SLIDES OF THE SLIP TIP SYRINGE VERY EASILY WHEREAS PRIOR IT USED TO COME AWAY FROM EACH OTHER WITHOUT AN ISSUE. THIS ANESTHETIST NOW USES A LUER LOCK SYRINGE SO THIS DOESN'T HAPPEN." ASSOCIATED MDR NUMBERS INCLUDE: 3006425876-2025-00743, 3006425876-2025-00792, AND 3006425876-2025-00793.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22772439 ↗
• MalfunctionAug 11, 2025Connection Problem; Connection Problem

  IT WAS REPORTED " WHEN THE SHEATH IS PUSHED INTO THE VEIN, THE ACTUAL CANNULA SLIDES OF THE SLIP TIP SYRINGE VERY EASILY WHEREAS PRIOR IT USED TO COME AWAY FROM EACH OTHER WITHOUT AN ISSUE. THIS ANESTHETIST NOW USES A LUER LOCK SYRINGE SO THIS DOESN'T HAPPEN." ASSOCIATED MDR NUMBERS INCLUDE: 3006425876-2025-00743, 3006425876-2025-00792.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22772407 ↗
• MalfunctionAug 11, 2025Connection Problem; Connection Problem

  IT WAS REPORTED "WHEN THE SHEATH IS PUSHED INTO THE VEIN, THE ACTUAL CANNULA SLIDES OF THE SLIP TIP SYRINGE VERY EASILY WHEREAS PRIOR IT USED TO COME AWAY FROM EACH OTHER WITHOUT AN ISSUE. THIS ANESTHETIST NOW USES A LUER LOCK SYRINGE SO THIS DOESN'T HAPPEN." THERE WAS NO PATIENT HARM OR INJURY. NO MEDICAL INTERVENTION REQUIRED. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE". ASSOCIATED MDR NUMBERS INCLUDE: 3006425876-2025-00743, 3006425876-2025-00792, AND 3006425876-2025-00793.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22770810 ↗
• MalfunctionMar 12, 2025Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED "FAULTY GUIDEWIRE WHEN INSERTING CENTRAL LINE ACCESS TO PATIENT".

  Patient problems: Insufficient Information

  MAUDE report 21584889 ↗
• MalfunctionOct 9, 2023Deformation Due to Compressive Stress; Physical Resistance/Sticking; Deformation Due to Compressive Stress; Physical Resistance/Sticking

  IT WAS REPORTED DURING THE CVC INSERTION PROCEDURE, THE GUIDEWIRE GOT STUCK WITHIN THE CVC AND COULD NOT BE REMOVED. THE CVC AND GUIDEWIRE WERE REMOVED TOGETHER AND A NEW CVC WAS USED TO COMPLETE THE PROCEDURE.

  Patient problems: Insufficient Information

  MAUDE report 17895006 ↗
• MalfunctionSep 29, 2023Material Separation; Material Separation

  IT WAS REPORTED A PATIENT PULLED AT HIS LINE AND BROKE ONE OF THE CATHETER LUMENS FROM THE CENTRAL LINE. NO PATIENT HARM REPORTED. THE CVC WAS REMOVED AND PATIENT WAS MANAGED WITH PERIPHERAL ACCESS ONLY AS HE NO LONGER REQUIRED THE CVC. THE PATIENT'S CONDITION IS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17843705 ↗
• MalfunctionSep 29, 2023Material Separation; Material Separation

  IT WAS REPORTED THE NURSE WAS WITHDRAWING BLOOD FROM THE CENTRAL LINE AND THE BROWN LUER HUB SEPARATED FROM THE CATHETER. NO PATIENT HARM WAS REPORTED. THE PATIENT HAD TO HAVE A PICC LINE INSERTED. THE PATIENT'S CONDITION IS REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17843563 ↗

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-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-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-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-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.