ARROW IPN000175Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00801902002105), received between Apr 30, 2021 and Mar 4, 2026 — classified as 8 malfunctions.

The most frequently reported specific device problem is “Material Twisted/Bent” (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 16, 2026.

Most reported problems

Recent adverse event reports

The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 4, 2026Material Twisted/Bent

  IT WAS REPORTED THAT"THE PATIENT WAS ADMITTED TO THE HOSPITAL AT 09:00 ON (B)(6) 2026. FOLLOWING ROUTINE DISINFECTION AND DRAPE PLACEMENT, A 5F PUNCTURE SHEATH WAS USED UNDER LOCAL ANESTHESIA. VENOUS PUNCTURE WAS SUCCESSFULLY PERFORMED AND A GUIDEWIRE WAS INDWELLING; HOWEVER, DURING THE ADVANCEMENT OF THE VASCULAR SHEATH OVER THE GUIDEWIRE, THE SHEATH SUSTAINED A KINK AND FAILED TO ADVANCE FURTHER. THE ENTIRE DEVICE WAS THEREFORE WITHDRAWN, AND A NEW SHEATH WAS REPLACED TO PERFORM THE PUNCTURE AGAIN."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24504618 ↗
• MalfunctionMar 4, 2026Material Puncture/Hole

  IT WAS REPORTED THAT: " (B)(6) 2026,VENOUS PUNCTURE WAS SUCCESSFULLY PERFORMED; HOWEVER, BURRS WERE FOUND AT THE DISTAL TIP OF THE SHEATH DURING THE ASSEMBLY OF THE VASCULAR SHEATH SET, RENDERING IT UNFIT FOR USE. NO HARM FOR THE PATIENT. THE PATIENT CONDITION IS FINE.NO MEDICAL INTERVENTION WAS REQUIRED."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24504595 ↗
• MalfunctionFeb 9, 2026Material Twisted/Bent

  IT WAS REPORTED THAT" ON (B)(6) 2026, DURING THE IMPLANTATION PROCEDURE, GUIDEWIRE KINKING OCCURRED WHICH PREVENTED THE VASCULAR SHEATH FROM BEING INSERTED SUCCESSFULLY. THE IMPLANTATION WAS COMPLETED WITHOUT INCIDENT AFTER SWITCHING TO A VASCULAR SHEATH OF ANOTHER BRAND. NO HARM FOR THE PATIENT. THE PATIENT CONDITION IS FINE. NO MEDICAL INTERVENTION WAS REQUIRED."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24290739 ↗
• MalfunctionFeb 9, 2026Material Twisted/Bent

  IT WAS REPORTED THAT" ON (B)(6) 2026, DURING THE IMPLANTATION PROCEDURE, GUIDEWIRE KINKING OCCURRED WHICH PREVENTED THE VASCULAR SHEATH FROM BEING INSERTED SUCCESSFULLY. THE IMPLANTATION WAS COMPLETED WITHOUT INCIDENT AFTER SWITCHING TO A VASCULAR SHEATH OF ANOTHER BRAND. NO HARM FOR THE PATIENT. THE PATIENT CONDITION IS FINE.NO MEDICAL INTERVENTION WAS REQUIRED."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24290725 ↗
• MalfunctionJun 25, 2024Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED " BEFORE THE PROCEDURE ACCORDING TO IFU, THE MD FOUND THE TIP OF THE DILATOR TO BE BENT/KINKED. SO THE MD OPENED UP A NEW PACKAGE TO FINISH THE PROCEDURE." THERE WAS NO PATIENT HARM OR INJURY. NO MEDICAL INTERVENTION REQUIRED. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19604362 ↗
• MalfunctionJan 19, 2024Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT: DURING THE PROCEDURE ACCORDING TO IFU, THE END OF THE DILATOR WAS FOUND TO BE BENT SO THE WIRE COULD NOT ENTER. SO MD OPENED UP THE NEW KIT TO FINISH THE PROCEDURE. THE PATIENT WAS REPORTED AS FINE WITH NO REPORTED PATIENT HARM OR CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18542718 ↗
• MalfunctionDec 4, 2023Deformation Due to Compressive Stress; Deformation Due to Compressive Stress

  IT WAS REPORTED THAT: THE SHEATH BODY WAS FOUND BENT UPON OPENING THE PACKAGE. THEREFORE, A NEW KIT WAS USED INSTEAD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18254697 ↗
• MalfunctionApr 30, 2021Material Deformation; Material Deformation

  IT WAS REPORTED "THE CATHETER TIP WAS BLUNT AND COULD NOT ENTER". A NEW DEVICE WAS OBTAINED TO FINISH THE PROCEDURE. NO PATIENT HARM REPORTED. THE PATIENT'S CONDITION IS REPORTED AS FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11755374 ↗

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-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-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-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

…and 9 more.