ARROW IPN035707 (REF CV-15703-M)Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00801902026408), received between Sep 23, 2024 and Mar 30, 2026 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Material Twisted/Bent” (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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 30, 2026Break

  IT WAS REPORTED THAT "THE PLACEMENT GUIDE BROKE DURING CATHETER PLACEMENT." THERE GUIDEWIRE WAS REMOVED AND REPLACED. THERE WAS NO P ATIENT 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 24729571 ↗
• MalfunctionAug 20, 2025Unraveled Material; Unraveled Material

  IT WAS REPORTED THAT " DURING THE INSTALLATION OF A CENTRAL VENOUS CATHETER IN THE CONTINUOUS ADMISSION AREA ON (B)(6) 2025, IT WAS OBSERVED THAT DURING THIS PROCEDURE, WHEN THE GUIDE WAS INSERTED, IT BENT DURING INSTALLATION AND BECAME SEPARATED FROM ITS INTEGRITY." THE PATIENT WAS MULTIPLE PUNCTURED AND HAD HEMATOMA FORMATION AT THE PUNCTURE SITE. THE PROBLEM WAS RESOLVED BY PLACING NEW EQUIPMENT. THE PREVIOUS CENTRAL VENOUS CATHETER WAS REMOVED. A NEW CATHETER WAS PLACED. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "DELICATE".

  Patient problems: Hematoma; Needle Stick/Puncture

  MAUDE report 22852890 ↗
• MalfunctionMar 28, 2025Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT "THREE ARROW CVC DEVICES WERE PLACED, HOWEVER, WHEN THE GUIDE WAS PASSED, ALL OF THEM BENT, MAKING THE CATHETER DIFFICULT TO PLACE, SO MULTIPLE PUNCTURES WERE PERFORMED DUE TO DIFFICULTY IN PASSING THROUGH THE GUIDE.". THE ASSOCIATED EMDR REPORT NUMBERS ARE 9680794-2025-00264, 9680794-2025-00262 AND 9680794-2025-00263.

  Patient problems: Needle Stick/Puncture

  MAUDE report 21719222 ↗
• MalfunctionMar 28, 2025Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT "THREE ARROW CVC DEVICES WERE PLACED, HOWEVER, WHEN THE GUIDE WAS PASSED, ALL OF THEM BENT, MAKING THE CATHETER DIFFICULT TO PLACE, SO MULTIPLE PUNCTURES WERE PERFORMED DUE TO DIFFICULTY IN PASSING THROUGH THE GUIDE.". THE ASSOCIATED EMDR REPORT NUMBERS ARE 9680794-2025-00264, 9680794-2025-00262 AND 9680794-2025-00263.

  Patient problems: Needle Stick/Puncture

  MAUDE report 21719196 ↗
• MalfunctionMar 28, 2025Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT "THREE ARROW CVC DEVICES WERE PLACED, HOWEVER, WHEN THE GUIDE WAS PASSED, ALL OF THEM BENT, MAKING THE CATHETER DIFFICULT TO PLACE, SO MULTIPLE PUNCTURES WERE PERFORMED DUE TO DIFFICULTY IN PASSING THROUGH THE GUIDE.". THE ASSOCIATED EMDR REPORT NUMBERS ARE. 9680794-2025-00262 AND 9680794-2025-00263.

  Patient problems: Needle Stick/Puncture

  MAUDE report 21719114 ↗
• MalfunctionSep 23, 2024Fracture; Difficult to Remove; Fracture; Difficult to Remove

  IT WAS REPORTED THAT "THE CVC IS PLACED AND A METAL GUIDEWIRE AND CATHETER ARE INSERTED, BUT WHEN THE GUIDEWIRE IS REMOVED IT IS DIFFICULT TO REMOVE AND IS FRACTURED. THE DOCTOR PERFORMED THE REMOVAL OF THE GUIDEWIRE WITHOUT SURGICAL INTERVENTION. THERE WAS NO REPORTED PATIENT HARM FROM THE INCIDENT." IT WAS REPORTED BY THE CLINICAL STAFF AT THE HOSPITAL THAT: THE PATIENT DIED 17DAYS LATER, REPORTED CAUSE OF DEATH WAS: METABOLIC ACIDOSIS 3 DAYS, SEPTIC SHOCK 12 DAYS, POST-CARDIORESPIRATORY ARREST SYNDROME 15 DAYS, CHRONIC KIDNEY DISEASE 2 MONTHS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20276953 ↗

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-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-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-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-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-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.