ARROW IPN033017Recalls & reported problems

Summary

The FDA's MAUDE database contains 25 adverse event reports that list this exact device (DI 30801921122939), received between Jul 31, 2023 and Nov 3, 2025 — classified as 25 malfunctions.

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

Most reported problems

Recent adverse event reports

The 25 most recent of 25 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 3, 2025Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT "THE CVC WAS REPLACED WITH A GUIDEWIRE. A NEW 5FR 13CM, 2-LUMEN CVC WAS PLACED. I NOTICED, WHEN TESTING IT, THAT AIR CAME OUT OF THE PROXIMAL LUMEN WHEN ASPIRATING ." THE CVC WAS REMOVED AND REPLACED. THERE WAS NO MEDICAL INTERVENTION REQUIRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23451436 ↗
• MalfunctionSep 23, 2025Material Frayed; Material Frayed

  IT WAS REPORTED "DOCTOR ANESTHESIOLOGIST (B)(6) HOSPITAL, SAID THAT WHEN PLACING THE CVC, THE NEEDLE GETS STUCK WHEN PASSING THE GUIDEWIRE AND FRAYS WHEN WITHDRAWING IT." THE NEEDLE AND GUIDEWIRE WAS REMOVED. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE". ASSOCIATED MDR NUMBERS INCLUDE: 9680794-2025-00788, 9680794-2025-00787, AND 9680794-2025-00769.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23123392 ↗
• MalfunctionMay 5, 2025Material Too Soft/Flexible; Material Too Soft/Flexible

  IT WAS REPORTED "11 APR 2025, FEEDBACK FROM SHANGHAI CHILDREN'S MEDICAL CENTRE ON THE INABILITY OF DILATOR TO EXPAND THE SKIN DURING CVC PUNCTURES." ADDITIONAL INFORMATION RECEIVED REPORTS THE "DILATOR IS TOO SOFT". 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 21959889 ↗
• MalfunctionMay 1, 2025Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED "11 APR 2025, FEEDBACK FROM (B)(6) MEDICAL CENTRE ON THE INABILITY OF DILATOR TO EXPAND THE SKIN DURING CVC PUNCTURES." 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 21941605 ↗
• MalfunctionMar 26, 2025Unraveled Material; Unraveled Material

  IT WAS REPORTED THAT: "DURING GUIDE WIRE INSERTION, SIGNIFICANT RESISTANCE WHILE INSERTING THE GUIDE WIRE, AND UPON ATTEMPTING TO REMOVE IT, THE GUIDE WIRE BECAME DISLODGED AND UNRAVELED.". THE WIRE WAS REMOVED AND THE PATIENT HAD NO HARM OR INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21698133 ↗
• MalfunctionJan 29, 2025Unraveled Material; Unraveled Material

  IT WAS REPORTED THAT; THE CATHETER WAS INSERTED FROM THE GROIN. WHEN REMOVING THE SWG AFTER PLACEMENT OF THE CATHETER, ONE-THIRD PART FROM THE BOTTOM OF THE SWG WAS UNRAVELLED. AFTER COMPLETING THE PROCEDURE, THE USER TOOK X-RAYS OF THE PATIENT'S LOWER BACK AND CHEST AND CONFIRMED THAT NO PIECE OF THE SWG REMAINED IN THE PATIENT. NO INJURY TO THE PATIENT OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21264700 ↗
• MalfunctionNov 8, 2024Stretched; Stretched

  IT WAS REPORTED "WHEN REMOVING THE CATHETER GUIDE, IT GETS STUCK AND DOES NOT COME OUT. WHEN REMOVING IT, IT STRETCHES AND DOES NOT WORK." THIS DEFECT WAS FOUND PRIOR TO USE ON THE PATIENT. THERE WAS NO MEDICAL INTERVENTION REQUIRED. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20639890 ↗
• MalfunctionNov 1, 2024Material Frayed; Material Frayed

  IT WAS REPORTED "ACCORDING TO THE REPORT OF THE SURGEON, THE GUIDE WIRES FRAYED AND BECAME ENTANGLED DURING THE PROCEDURE." THERE WAS NO MEDICAL INTERVENTION REQUIRED. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "UNKNOWN". ADDITIONAL INFORMATION HAS NOT BEEN PROVIDED AT THIS TIME. ASSOCIATED MDR NUMBERS: 3006425876-2024-01039.

  Patient problems: Insufficient Information

  MAUDE report 20585467 ↗
• MalfunctionNov 1, 2024Material Frayed; Material Frayed

  IT WAS REPORTED "ACCORDING TO THE REPORT OF THE SURGEON, THE GUIDE WIRES FRAYED AND BECAME ENTANGLED DURING THE PROCEDURE." THERE WAS NO MEDICAL INTERVENTION REQUIRED. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "UNKNOWN". ADDITIONAL INFORMATION HAS NOT BEEN PROVIDED AT THIS TIME. ASSOCIATED MDR NUMBERS INCLUDE:3006425876-2024-01040.

  Patient problems: Insufficient Information

  MAUDE report 20585460 ↗
• MalfunctionOct 23, 2024Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED "THE GUIDE WIRE AT THE TOP WAS BENT." THIS WAS FOUND PRIOR TO USE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20514820 ↗
• MalfunctionSep 3, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED "IN ICU, THE NURSE FOUND THE EXTENSION LINE WAS LEAKING DURING USE ON THE PATIENT. AFTER THAT THEY REMOVE THE CATHETER." 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 20129774 ↗
• MalfunctionJul 22, 2024Material Twisted/Bent; Physical Resistance/Sticking; Material Twisted/Bent; Physical Resistance/Sticking

  IT WAS REPORTED THAT: "DURING CENTRAL VENOUS CATHETER PLACEMENT IN THE SURGERY ROOM.WHEN THE BLOOD VESSEL IS CANALIZED AND THE METAL GUIDE IS PASSED, IT GETS STUCK IN THE NEEDLE. THEY WERE FORCED TO REMOVE IT OUT OF THE BLOOD VESSEL AND WHEN THE METAL GUIDE IS REMOVED, THE DEFORMATION OF THE METAL GUIDE IS OBSERVED".

  Patient problems: Insufficient Information

  MAUDE report 19791656 ↗
• MalfunctionMar 19, 2024Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT: "THE PATIENT WAS ADMITTED TO THE HOSPITAL FOR ACUTE LYMPHOCYTIC LEUKAEMIA AND UNDERWENT CENTRAL VENOUS PUNCTURE TREATMENT AT 10:00 AM ON (B)(6) 20 24. BEFORE USING THE CENTRAL VENOUS CATHETER PACKAGE, DOCTOR HAD CHECKED THE PRODUCT (WHETHER IT WAS INTACT AND DAMAGED). AT 10:30 AM, THE GUIDE WIRE COULD NOT BE INSERTED, AND UPON EXAMINATION, IT WAS FOUND THAT THERE WAS A KINKED PROBLEM WITH THE GUIDE WIRE. THEN USE THE OTHER END OF THE GUIDE WIRE TO ADVANCE. THE PATIENT WAS REPORTED AS FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18928372 ↗
• MalfunctionFeb 9, 2024Material Separation; Material Separation

  IT WAS REPORTED "WHEN INSERTING THE CENTRAL CATHETER, THE GUIDE WIRE "DISINTEGRATED" IN THE SURGEON'S HAND." NO PATIENT INJURY. UNABLE TO RECEIVE ADDITIONAL INFORMATION FOR THIS REPORT. NO FURTHER COMPLAINT DETAILS AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 18681436 ↗
• MalfunctionJan 8, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT: (B)(6) 2023, THE DOCTOR FOUND THE SWG SEPARATED DURING USE ON THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18463433 ↗
• MalfunctionDec 19, 2023Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT: (B)(6) 2023, THE SWG WAS FOUND KINKED DURING USED ON THE PATIENT. PATIENT WAS REPORTED AS FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18354326 ↗
• MalfunctionDec 15, 2023Deformation Due to Compressive Stress; Deformation Due to Compressive Stress

  IT WAS REPORTED THAT: THE SWG WAS FOUND TO BE KINKED DURING USE ON PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18333691 ↗
• MalfunctionDec 11, 2023Product Quality Problem; Material Separation; Product Quality Problem; Material Separation

  IT WAS REPORTED THAT: "(B)(6) 2023, THE DOCTOR FOUND THE SWG TIP ROUGH FEEL/APPEARANCE DURING USED ON THE PATIENT. THE SWG TIP PIERCE OF BLOOD VESSEL WALL." THE PATIENT WAS REPORTED AS "GOOD". ADDITIONAL INFORMATION HAS BEEN REQUESTED FROM THE ACCOUNT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18299960 ↗
• MalfunctionDec 11, 2023Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT: (B)(6) 2023, THE ARS WAS FOUND LEAKING DURING USED ON THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18299531 ↗
• MalfunctionNov 29, 2023Material Separation; Deformation Due to Compressive Stress; Physical Resistance/Sticking; Material Separation; Deformation Due to Compressive Stress; Physical Resistance/Sticking

  IT WAS REPORTED THAT: (B)(6) 2023, THE SWG WAS FOUND TO BE KINKED DURING USE ON THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18228607 ↗
• MalfunctionNov 17, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT: THE ADAPTER WAS DETACHED FROM THE DISTAL LUMEN OF THE EXTENSION. ADDITIONAL INFORMATION RECEIVED 19-JAN-2024 INDICATES THERE WAS NO PATIENT INJURY/HARM. IT WAS ALSO REPORTED THAT "THE CATHETER WAS CHANGED AT A DIFFERENT INSERTION SITE".

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 18159832 ↗
• MalfunctionOct 2, 2023Deformation Due to Compressive Stress; Deformation Due to Compressive Stress

  IT WAS REPORTED THAT: THE SWG WAS FOUND TO BE KINKED. THE ISSUE WAS IDENTIFIED PRIOR TO USE ON PATIENT. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17850812 ↗
• MalfunctionSep 22, 2023Unraveled Material; Unraveled Material

  IT WAS REPORTED THAT "SURGEON REPORTS THAT IT WAS NECESSARY TO USE 3 CATHETERS TO ACHIEVE SUCCESSFUL PUNCTURE. TWO OF THESE CATHETERS PRESENTED BENDING AND FRAYING IN THE GUIDEWIRE, MAKING IT IMPOSSIBLE TO PASS THE ACCESS." THE THIRD CATHETER WAS SUCCESSFULLY PLACED. THE PATIENT'S CONDITION IS REPORTED AS FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17798759 ↗
• MalfunctionSep 22, 2023Unraveled Material; Unraveled Material

  IT WAS REPORTED THAT "SURGEON REPORTS THAT IT WAS NECESSARY TO USE 3 CATHETERS TO ACHIEVE SUCCESSFUL PUNCTURE. TWO OF THESE CATHETERS PRESENTED BENDING AND FRAYING IN THE GUIDEWIRE, MAKING IT IMPOSSIBLE TO PASS THE ACCESS." THE THIRD CATHETER WAS SUCCESSFULLY PLACED. THE PATIENT'S CONDITION IS REPORTED AS FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17798692 ↗
• MalfunctionJul 31, 2023Unraveled Material; Physical Resistance/Sticking; Unraveled Material; Physical Resistance/Sticking

  IT WAS REPORTED "THE GUIDE WIRE SHREDDED DURING THE PASSAGE OF THE CATHETER".

  Patient problems: Insufficient Information

  MAUDE report 17423748 ↗

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-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-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-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-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

…and 9 more.