ARROW IPN030909Recalls & reported problems

Summary

The FDA's MAUDE database contains 154 adverse event reports that list this exact device (DI 00801902105455), received between Jul 11, 2023 and Nov 3, 2025 — classified as 154 malfunctions.

The most frequently reported specific device problem is “Material Twisted/Bent” (53 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 25 most recent of 154 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 3, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT "(B)(6) 2025, THE PATIENT TURNED OVER IN THE BED AND THE SLIDE CLAMP FALLING, AND WAS LOST AGAIN AFTER REINSTALLATION." ANOTHER SIDE CLAMP WAS USED 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 23451063 ↗
• MalfunctionOct 15, 2025Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT "ON (B)(6) 2025, (B)(6) CENTER, SECOND AFFILIATED HOSPITAL OF (B)(6) UNIVERSITY, THE DOCTOR FOUND SWG KINKED PRIOR TO THE PATIENT." THE USER CHANGED TO A NEW SET TO RESOLVE THE ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23278853 ↗
• MalfunctionOct 8, 2025Difficult to Insert; Material Deformation; Difficult to Insert; Material Deformation

  IT WAS REPORTED THAT " ON (B)(6) 2025, THE DOCTOR FOUND THE DILATOR TIP DAMAGED, AND THE SWG CAN'T INSERT INTO IT." 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 23243843 ↗
• MalfunctionSep 24, 2025Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT "(B)(6) 2025, THE DOCTOR OPEN THE PACKAGE, THE SWG WAS FOUND KINKED PRIOR TO THE PATIENT." THE USER CHANGED TO A NEW SET TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23132263 ↗
• MalfunctionAug 6, 2025Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED "ON (B)(6) 2025, THE DOCTOR FOUND SWG KINKED DURING USE ON THE PATIENT." 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 22725743 ↗
• MalfunctionJul 24, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED "(B)(6) 2025, THE DOCTOR FOUND EXTENSION LINE LEAK DURING USE ON THE PATIENT." 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 22588508 ↗
• MalfunctionJul 9, 2025Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT "THE GUIDE WIRE FORMED AN ELBOW WHEN PASSING THE CATHETER. A NEW ATTEMPT TO PASS IT WITH A NEW CATHETER WAS MADE AND THE GUIDE WIRE BENT AGAIN AND DID NOT RECOVER ITS ORIGINAL SHAPE, REQUIRING A 3RD INSERTION, THIS LAST ONE WHICH WAS SUCCESSFUL." THE PATIENT'S CURRENT CONDITION IS REPORTED AS "UNKNOWN". ASSOCIATED MDR NUMBERS INCLUDE: 9680794-2025-00599 AND 9680794-2025-00598.

  Patient problems: Insufficient Information

  MAUDE report 22458045 ↗
• MalfunctionJul 9, 2025Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED "THE GUIDE WIRE FORMED AN ELBOW WHEN PASSING THE CATHETER. A NEW ATTEMPT TO PASS IT WITH A NEW CATHETER WAS MADE AND THE GUIDE WIRE BENT AGAIN AND DID NOT RECOVER ITS ORIGINAL SHAPE, REQUIRING A 3RD INSERTION, THIS LAST ONE WHICH WAS SUCCESSFUL." THE PATIENT'S CURRENT CONDITION IS REPORTED AS "UNKNOWN". ASSOCIATED MDR NUMBERS INCLUDE: 9680794-2025-00599 AND 9680794-2025-00598.

  Patient problems: Insufficient Information

  MAUDE report 22458007 ↗
• MalfunctionJul 9, 2025Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED "DURING INSPECTION AND LABELING, WE FOUND TWO DAMAGED AND PUNCTURED PACKAGES INSIDE THE BOX". THERE WAS NO PATIENT INVOLVEMENT. ASSOCIATED MDR NUMBERS INCLUDE: 9680794-2025-00580.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22457364 ↗
• MalfunctionJul 9, 2025Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED "DURING INSPECTION AND LABELING, WE FOUND TWO DAMAGED AND PUNCTURED PACKAGES INSIDE THE BOX". THERE WAS NO PATIENT INVOLVEMENT. ASSOCIATED MDR NUMBERS INCLUDE: 9680794-2025-00581.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22457299 ↗
• MalfunctionJul 8, 2025Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED, "THE WHITE CATHETER PATH IS CLOGGED." THE PATIENT'S CURRENT CONDITION IS REPORTED AS "UNKNOWN". ADDITIONAL INFORMATION HAS BEEN REQUESTED; HOWEVER, FURTHER DETAILS HAVE NOT BEEN PROVIDED AT THIS TIME.

  Patient problems: Insufficient Information

  MAUDE report 22437670 ↗
• MalfunctionJun 25, 2025Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED "(B)(6) 2025 , THE INPATIENT HAD A CENTRAL VENOUS LINE (DOUBLE LUMEN) PLACED IN THE ULTRASOUND DEPARTMENT, AND DURING THE POSTOPERATIVE WARD NURSING OPERATION, IT WAS NOTED THAT THE SECONDARY LINE WAS ABLE TO BE WITHDRAWN AND INJECTED BUT NOT FLUENTLY, AND THE PRIMARY LINE WAS WITHDRAWN AND INJECTED VERY FLUENTLY. THERE WAS A BLOCKAGE IN THE ACCESS TO THE SECONDARY LINE, WHICH WAS NOT FUNCTIONING PROPERLY." 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 22332206 ↗
• MalfunctionJun 20, 2025Difficult to Advance; Material Twisted/Bent; Difficult to Advance; Material Twisted/Bent

  IT WAS REPORTED "ON (B)(6) 2025, THE DOCTOR FOUND IT WAS DIFFICULT TO ADVANCE THE SWG INSERTION INTO ARS. IT WAS FOUND KINKED AFTER REMOVE." 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 22298307 ↗
• MalfunctionMay 28, 2025Difficult to Advance; Material Twisted/Bent; Difficult to Advance; Material Twisted/Bent

  IT WAS REPORTED "(B)(6) 2025, DURING THE INSERTION, THE DOCTOR FOUND THE SWG IS DIFFICULT INTO THE VESSEL FROM THE NEEDLE, AND THE SWG WAS FOUND KINKED WHEN REMOVED." 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 22096259 ↗
• MalfunctionMay 7, 2025Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED "(B)(6) 2025, THE INPATIENT HAD A CENTRAL VENOUS LINE (DOUBLE LUMEN) PLACED IN THE ULTRASOUND DEPARTMENT, AND DURING THE POSTOPERATIVE WARD NURSING OPERATION, IT WAS NOTED THAT THE SECONDARY LINE WAS ABLE TO BE WITHDRAWN AND INJECTED BUT NOT FLUENTLY, AND THE PRIMARY LINE WAS WITHDRAWN AND INJECTED VERY FLUENTLY. THERE WAS A BLOCKAGE IN THE ACCESS TO THE SECONDARY LINE, WHICH WAS NOT FUNCTIONING PROPERLY." 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 21975743 ↗
• MalfunctionMay 1, 2025Leak/Splash; Leak/Splash

  IT WAS REPORTED "CENTRAL VENOUS CATHETER, WHICH WHEN UNCLOGGED AND ITS FUNCTIONALITY IS FOUND TO BE DYSFUNCTIONAL LUMEN." ADDITIONAL INFORMATION CLARIFIED THE LEAK "WAS DETECTED WHEN THE CATHETER WAS FLUSHED WHILE INSIDE OF THE PATIENT". THE CATHETER WAS REMOVED AND A NEW CATHETER WAS PLACED. 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 21941727 ↗
• MalfunctionApr 17, 2025Break; Break

  IT WAS REPORTED "TWO NEEDLES WERE BROKEN DURING THE PUNCTURE ATTEMPT." THE PATIENT'S CURRENT CONDITION IS UNKNOWN AT THIS TIME. ASSOCIATED MDR NUMBERS INCLUDE: 9680794-2025-00346 AND 9680794-2025-00341.

  Patient problems: Insufficient Information

  MAUDE report 21859917 ↗
• MalfunctionApr 17, 2025Break; Break

  IT WAS REPORTED "TWO NEEDLES WERE BROKEN DURING THE PUNCTURE ATTEMPT." THE PATIENT'S CURRENT CONDITION IS UNKNOWN AT THIS TIME. ASSOCIATED MDR NUMBER: 9680794-2025-00341.

  Patient problems: Insufficient Information

  MAUDE report 21859419 ↗
• MalfunctionApr 16, 2025Difficult to Remove; Difficult to Remove

  IT WAS REPORTED "ON (B)(6) 2024, THE DOCTOR FOUND THE SWG WAS STUCK IN THE ARS WHEN THE SWG REMOVE FROM THE ARS." 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 21846504 ↗
• MalfunctionApr 14, 2025Material Deformation; Material Deformation

  IT WAS REPORTED "CVC GUIDE WIRE HAS DEFECTIVE STRUCTURE." THE PATIENT'S CURRENT CONDTION IS REPORTED AS "UNKNOWN". ADDITIONAL INFORMTION WAS REQUESTED; HOWEVER, FURTHER DETAILS CAN NOT BE PROVIDED AT THIS TIME.

  Patient problems: Insufficient Information

  MAUDE report 21835011 ↗
• MalfunctionApr 11, 2025Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED "THE CATHETER WAS PUNCTURED ALONG ITS LENGTH." ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER STATES THERE WAS "A HOLE IN THE EXTENSION". THE DEVICE WAS REMOVED AND REPLACED. THERE WAS NO PATIENT HARM OR INJURY. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "HEMODYNAMICALLY STABLE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21824602 ↗
• MalfunctionApr 10, 2025Difficult to Insert; Material Twisted/Bent; Difficult to Insert; Material Twisted/Bent

  IT WAS REPORTED "(B)(6) 2025, DURING THE INSERTION, THE DOCTOR FOUND THE SWG IS VERY DIFFICULT TO INSERT INTO THE ARS DURING USE ON THE PATIENT." ADDITIONAL INFORMATION RECEIVED REPORTS "THE SWG WAS FOUND KINKED". THE USER CHANGED TO A NEW SET TO RESOLVE THE ISSUE. 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 21813121 ↗
• MalfunctionApr 10, 2025Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED "THE GUIDE WIRE IS NOT VERY MOBILE AND BENDS EASILY. GUIDE WIRE SNAGS WHEN ACCESS IS MADE." ADDITIONAL INFORMATION RECEIVED STATES THIS OCCURED "AFTER REMOVING THE INTRODUCTORY NEEDLE." THERE WAS NO PATIENT HARM OR INJURY. NO MEDICAL INTERVENTION REQUIRED. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "STABLE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21812663 ↗
• MalfunctionApr 9, 2025Unraveled Material; Material Twisted/Bent; Unraveled Material; Material Twisted/Bent

  IT WAS REPORTED "THE WIRES COVERING THE GUIDE WIRE TEAR ON THEIR OWN. THE "CORE" OF THE GUIDE COMES APART WITHOUT SUFFICIENT TWISTING. THE GUIDE BENDS AT THE SLIGHTEST CURVE. THE MATERIAL IS OF LOWER QUALITY THAN EXPECTED, ALWAYS FROM THE SAME BRAND (ARROW). TECHNICAL COMPLAINTS FOR ARROW (CVC MATERIAL) HAVE BEEN MADE SEVERAL TIMES WITHOUT IMPROVEMENT." THE PATIENT'S CURRENT CONDITION IS UNKNOWN AT THIS TIME. ADDITIONAL INFORMATION FROM THE CUSTOMER HAS NOT BEEN PROVIDED. ASSOCIATED MDR NUMBER INCLUDE: 9680794-2025-00282.

  Patient problems: Insufficient Information

  MAUDE report 21808096 ↗
• MalfunctionMar 18, 2025Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT A QUALITY DEFECT WAS IDENTIFIED WITH VENOUS CATHETER AFTER OPENING THE PACKAGING, SINCE IT IS CRUSHED AND GLUED WITH THE PACKAGING, THEREFORE CANNOT BE USED, THE STERILITY OF THE DEVICE WAS CONSIDERED LOST.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21630649 ↗

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-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-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-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-0650-2018 · Oct 17, 2017 · Terminated
  Multi Lumen Central Venous Catheterization Kit; Product Code: ASK-12703-HH2; 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-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.