ARROW IPN918771Recalls & reported problems

Summary

The FDA's MAUDE database contains 22 adverse event reports that list this exact device (DI 10801902183771), received between Nov 14, 2025 and Apr 14, 2026 — classified as 1 injury, 21 malfunctions.

The most frequently reported specific device problem is “Material Twisted/Bent” (12 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 22 most recent of 22 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 14, 2026Obstruction of Flow

  IT WAS REPORTED "PATIENT WITH METASTATIC CERVICAL CANCER, WITH MALIGNANT OBSTRUCTION, INDICATED FOR CVC DUE TO PARENTERAL NUTRITION. A SUCCESSFUL ULTRASOUND- GUIDED INSERTION WAS PERFORMED BY THE VASCULAR ACCESS SERVICE, CORRECT POSITIONING AND USE WERE CONFIRMED. HOWEVER, DYSFUNCTION OF THE DEVICE HAS BEEN PRESENT SINCE DAY 9 POST-INSERTION, WITH LUMEN OCCLUSION AND RETURN OF ALL INFUSIONS." THE USER REPLACED THE DEVICE. THERE WAS NO PATIENT HARM OR INJURY. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24873092 ↗
• MalfunctionApr 3, 2026Material Twisted/Bent

  IT WAS REPORTED THAT "ON (B)(6) 2026, THE ANESTHESIOLOGIST REPORTED THAT 2 SETS WERE CONSECUTIVELY FOUND DURING USE. THE GUIDE WIRE WAS BENT, MAKING PUNCTURE IMPOSSIBLE." THE USER CHANGED TO A NEW SET TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT HARM OR INJURY. NO MEDICAL INTERVENTION REQUIRED. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE". ASSOCIATE MDR NUMBERS INCLUDE: 3006425876-2026-00369.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24781845 ↗
• MalfunctionApr 3, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT "DURING DRESSING CHANGE, FLUID LEAKAGE WAS OBSERVED AT THE INTERFACE BETWEEN THE CATHETER AND SUTURE WING. AFTER EVALUATION, THE CATHETER WAS NO LONGER SERVICEABLE AND WAS REMOVED. A NEW CENTRAL VENOUS CATHETER WAS RE-INSERTED TO CONTINUE TREATMENT". ADDITIONAL INFORMATION RECEIVED STATES THAT "NO HARM FOR THE PATIENT. THE PATIENT CONDITION IS FINE. NO MEDICAL INTERVENTION WAS REQUIRED. THEY CHANGED A NEW ONE TO RESOLVE THE ISSUE.".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24779394 ↗
• MalfunctionApr 3, 2026Material Twisted/Bent

  IT WAS REPORTED THAT "09 MAR 2026, THE ANESTHESIOLOGIST REPORTED THAT 2 SETS WERE CONSECUTIVELY FOUND DURING USE. THE GUIDE WIRE WAS BENT, MAKING PUNCTURE IMPOSSIBLE." THE USER CHANGED TO A NEW SET TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT HARM OR INJURY. NO MEDICAL INTERVENTION REQUIRED. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE". ASSOCIATE MDR NUMBERS INCLUDE: 3006425876-2026-00370.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24777249 ↗
• MalfunctionMar 23, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT "(B)(6) 2026, LEAKAGE OCCURRED AT THE PUNCTURE SITE DURING INFUSION VIA THE MEASURING LUMEN CATHETER, WHICH MADE IT IMPOSSIBLE TO ENSURE THE ACTUAL DOSE OF THE INFUSED DRUG ENTERING THE PATIENT'S BODY, AND INCREASED THE RISK OF INFECTION FOR THE PATIENT. THE PATIENT UNDERWENT CATHETER REMOVAL; RE-CATHETERIZATION WAS NOT REQUIRED. THE PATIENT HAD A DOUBLE-LUMEN CVC CATHETER INDWELLED ON (B)(6) 2025." 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 24661351 ↗
• MalfunctionMar 9, 2026Material Twisted/Bent

  IT WAS REPORTED THAT "(B)(6) 2026, THE SWG WAS FOUND KINKED DURING INSERTION INTO PATIENT." THE USER CHANGED TO A NEW SET TO COMPLETE 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 24545811 ↗
• MalfunctionFeb 25, 2026Dull, Blunt

  IT WAS REPORTED THAT "DURING CENTRAL CATHETER INSERTION, IT WAS OBSERVED THAT THE NEEDLE INCLUDED IN THE CENTRAL CATHETER SET DOES NOT HAVE A BEVEL. THIS WAS NOTED AFTER AN ATTEMPT AT PUNCTURE FAILED TO PENETRATE THE SKIN. SINCE IT IS ESSENTIAL FOR THE NEEDLE TO HAVE A BEVEL TO ACHIEVE PUNCTURE, AND BECAUSE IT COMES INSIDE THE SET WITH NO POSSIBILITY OF USING ANOTHER ONE OR REQUESTING IT SEPARATELY." THERE WAS NO PATIENT HARM OR INJURY. NO MEDICAL INTERVENTION REQUIRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24443507 ↗
• MalfunctionFeb 4, 2026Material Twisted/Bent

  IT WAS REPORTED THAT "(B)(6) 2026, THE ANESTHESIOLOGIST FROM THE DEPARTMENT OF ANESTHESIOLOGY AT (B)(6) REPORTED DIFFICULTIES IN INSERTING THE GUIDEWIRE, AND UPON REMOVAL, FOUND THAT THE FRONT END WAS ABOUT TO BREAK OFF." THE USER CHANGED TO A NEW SET TO RESOLVE THE ISSUE. 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 24258030 ↗
• MalfunctionJan 21, 2026Suction Problem

  IT WAS REPORTED THAT "(B)(6) 2025, DEC THE FIRST AFFILIATED HOSPITAL OF (B)(6) REPORTED THAT DURING THE USE OF OUR CENTRAL VENOUS CATHETER (CVC), THE ARS WAS FAILED TO ASPIRATE AND COULD NOT BE USED NORMALLY. THE ISSUE WAS RESOLVED AFTER ARS REPLACEMENT." 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 24133295 ↗
• MalfunctionJan 21, 2026Leak/Splash

  IT WAS REPORTED THAT "(B)(6) 2025, A PATIENT UNDERWENT ULTRASOUND-GUIDED DOUBLE-LUMEN CENTRAL VENOUS CATHETERIZATION IN THE ULTRASONOGRAPHY DEPARTMENT. PERICATHETER FLUID LEAKAGE WAS OBSERVED IMMEDIATELY AFTER CATHETER PLACEMENT. THE CATHETER WAS REMOVED AND REINSERTED, AFTER WHICH THE LEAKAGE CEASED." 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 24131556 ↗
• MalfunctionJan 13, 2026Material Twisted/Bent

  IT WAS REPORTED THAT "(B)(6) 2025, WHEN TEACHER (B)(6) FROM THE EMERGENCY DEPARTMENT OF (B)(6) HOSPITAL WAS PERFORMING CATHETERIZATION, THE GUIDEWIRE WAS FOUND KINKED. A NEW CATHETER WAS REPLACED PROMPTLY." 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 24052879 ↗
• MalfunctionJan 13, 2026Unraveled Material

  IT WAS REPORTED THAT "(B)(6) 2025, WHEN TEACHER (B)(6) FROM THE EMERGENCY DEPARTMENT OF (B)(6) HOSPITAL WAS PERFORMING CATHETERIZATION, THE GUIDEWIRE WAS FOUND UNRAVELED. A NEW CATHETER WAS REPLACED PROMPTLY." THERE WAS NO PATIENT HARM OR INJURY. NO MEDICAL INTERVENTION IS REQUIRED. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24052719 ↗
• MalfunctionJan 6, 2026Leak/Splash

  IT WAS REPORTED THAT "(B)(6) 2025, IN ICU, THE HOSPITAL FOUND NEEDLE LEAK DURING USE ON THE PATIENT." THERE WAS NO MEDICAL INTERVENTION REQUIRED. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE".

  Patient problems: Insufficient Information

  MAUDE report 23986151 ↗
• MalfunctionJan 6, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT "ON (B)(6) 2025, THE PATIENT'S CONDITION REQUIRED DEEP VEIN CATHETERIZATION. ON THE AFTERNOON OF (B)(6) THE NURSE FOUND THAT THE EXTENSION LINE WAS LEAK. UPON CAREFUL EXAMINATION, IT WAS DISCOVERED EXTENSION LINE DAMAGED. REPORT TO THE SUPERVISING DOCTOR AND HEAD NURSE TO REMOVE THE DEEP VEIN CATHETER AND REPLACE IT WITH A SHALLOW VEIN CATHETER." THE USER CHANGED TO A NEW SET TO RESOLVE THE ISSUE. 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 23986119 ↗
• InjuryJan 2, 2026Material Twisted/Bent

  IT WAS REPORTED THAT "AT THE MOMENT OF PASSAGE OF THE RIGHT SUBCLAVIAN DOUBLE-LUMEN CENTRAL CATHETER, THERE IS NO RETURN OF THE CATHETER GUIDE, AS EVIDENCED BY X-RAY AND ULTRASOUND, WHICH SHOW IT COILED AROUND AN UNKNOWN OBJECT." ADDITIONAL INFORMATION RECEIVED STATES "AT THE END OF THE GUIDE PASSAGE, IT IS FOUND TO BE DYSFUNCTIONAL, CATHETER PLACEMENT ATTEMPTED USING THE SELDINGER TECHNIQUE, NOT POSSIBLE, FINALLY, ATTEMPT TO REMOVE THE GUIDE IS UNSUCCESSFUL DUE TO GREAT RESISTANCE. A RIGHT JUGULAR CATHETER IS INSERTED GUIDED BY ULTRASOUND, WITH A SINGLE PUNCTURE USING THE SELDINGER TECHNIQUE WITHOUT COMPLICATIONS. AN X-RAY IS TAKEN, SHOWING EVIDENCE OF A KNOT-SHAPED GUIDE. THE HEMODYNAMICS SERVICE IS CALLED, WHICH INDICATES THAT A VASCULAR STUDY SHOULD BE PERFORMED AND THE POSITION OF THE GUIDE SHOULD BE VERIFIED". ENDOVASCULAR REMOVAL OF INTRAVASCULAR FOREIGN BODY WAS PERFORMED BY IN TERVENTIONAL RADIOLOGY ON 12/10/2025. THERE WAS NO PATIENT HARM OR INJURY. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "UNKNOWN".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23943132 ↗
• MalfunctionDec 30, 2025Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT: "(B)(6) 2025, CVC INSERTION WAS PERFORMED. DURING INSERTION, THE SWG WAS FOUND TO BE KINKED, IMMEDIATE CVC REPLACEMENT AND SUCCESSFUL REINSERTION PERFORMED. THE PATIENT WAS REPROTED AS FINE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23921944 ↗
• MalfunctionDec 30, 2025Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT: "WHEN INSERTING THE CENTRAL VENOUS CATHETER, IT DOES NOT STAY STRAIGHT; THE GUIDE WIRE BENDS AS IT PASSES THROUGH, DAMAGING THE WALL OF THE BLOOD VESSEL."

  Patient problems: Unspecified Vascular Problem

  MAUDE report 23921174 ↗
• MalfunctionDec 29, 2025Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT "THE SWG WAS FOUND KINKED DURING USED ON THE PATIENT". NO PATIENT HARM OR INJURY. THE PATIENT STATUS IS REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23907093 ↗
• MalfunctionDec 22, 2025Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT"(B)(6) 2025, THE PATIENT REQUIRED INTRAVENOUS INFUSION, AND THE DOCTOR PERFORMED VENIPUNCTURE USING A CENTRAL VENOUS CATHETER (CVC) KIT. HOWEVER, UPON OPENING THE NEWLY UNSEALED CVC KIT, THE SWG WAS FOUND KINKED, THEN THEY CHANGED A NEW ONE." THIS WAS FOUND PRIOR TO USE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23864412 ↗
• MalfunctionDec 18, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT "DURING REMOVAL AT THE END OF USE, A CATHETER BREAKAGE INSIDE THE VESSEL WAS DETECTED. THE CATHETER WAS SUCCESSFULLY REMOVED, AND AN ULTRASOUND CHECK CONFIRMED THAT NO FRAGMENTS REMAINED INSIDE THE VESSEL". NO PATIENT HARM OR INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23839927 ↗
• MalfunctionNov 21, 2025Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT "(B)(6) 2025, DURING THE INSERTION, THE SWG WAS FOUND KINKED DUE TO THE NEEDLE DULL DURING USE ON THE PATIENT." THEY CHANGED TO A NEW SET TO RESOLVE THE ISSUE. THERE WAS NO PATIENT HARM OR INJURY. NO MEDICAL INTERVENTION REQUIRED. THE PATIENT CURRENT CONDITION IS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23622544 ↗
• MalfunctionNov 14, 2025Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT "ON (B)(6) 2025, IN M11 WARD, THE DOCTOR PERFORMED DEEP VEIN CATHETERIZATION FOR THE PATIENT. THE NEW CENTRAL VENOUS CATHETER BAG WAS USED DURING THE OPERATION, AND THE PUNCTURE WAS SMOOTH. DURING THE CATHETERIZATION PROCESS, THE GUIDE WIRE WAS FOUND KINKED, SO THE CATHETER COULD NOT BE PLACED. THE GUIDE WIRE WAS REPLACED IMMEDIATELY, AND THE DEEP VEIN CATHETERIZATION COULD BE SUCCESSFULLY COMPLETED. THE REPLACEMENT WAS TIMELY, WITHOUT CAUSING HARM TO THE PATIENT." 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 23555655 ↗

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-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-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.