ARROW IPN037072Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 30801902119644), received between Sep 27, 2021 and Sep 5, 2024 — classified as 1 injury, 12 malfunctions.

The most frequently reported specific device problem is “Deformation Due to Compressive Stress” (8 reports).

1 FDA recall record name this device's identifier, 1 still open.

54 other recalls cover devices cleared under the same FDA submission (K071538); 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.

Recalls naming this device

1. Apr 21, 2026Open, Classified

   Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and sets. The supplier was found to have quality issues and limited reports of drug ineffectiveness, and if sterility of a water-based injectable product is compromised this could lead to serious or life-threatening injuries.

   Z-2384-2026 · Root cause: Nonconforming Material/Component · FDA record ↗

Most reported problems

Recent adverse event reports

The 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 5, 2024Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT: "DR. WAS INSERTING THE GUIDE WIRE INTO PATIENT IT WOULD NOT ADVANCE. WE DISCOVERED A KINK IN WIRE, UPON EXAMINING THE WIRE THEY FOUND A SECOND KINK. IT WAS REMOVED FOR PT SAFETY WE STARTED OVER WITH A NEW CENTRAL LINE KIT. THE PATIENT CONDITION WAS REPORTED AS "FINE". NO PATIENT INJURY/CONSEQUENCE OR MEDICAL INTERVENTION REPORTED.".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20143826 ↗
• InjurySep 15, 2023Material Separation; Unraveled Material; Material Separation; Unraveled Material

  CUSTOMER COMPLAINT REPORTS: THE PA REPORTED NO ISSUES PLACING THE LINE. THE WIRE WENT IN SMOOTHLY AND CAME OUT SMOOTHLY. THE POST-PROCEDURE CHEST X-RAY SHOWED RETAINED WIRE IN THE RA. THE PA FOUND THE WIRE AND IT APPEARED THAT IT UNCOILED AND BROKE OFF INSIDE THE PATIENT. THE PATIENT NEEDED TO BE TRANSFERRED TO A TERTIARY CARE CENTER FOR POSSIBLE IR INTERVENTION FOR REMOVAL. ADDITIONAL INFORMATION WAS REQUESTED BUT WAS NOT AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: Foreign Body In Patient

  MAUDE report 17756757 ↗
• MalfunctionJan 13, 2022Deformation Due to Compressive Stress; Deformation Due to Compressive Stress

  TWO GUIDEWIRES FAILED ON ONE PATIENT. INITIAL ATTEMPT AT LEFT FEMORAL CENTRAL LINE PLACEMENT COMPLICATED BY WIRE KINK. CANNULATION WAS SUCCESSFUL AND WIRE PLACEMENT CONFIRMED ON US HOWEVER ON DILATION CRITICAL KINK TO WIRE FORMED. PRESSURE HELD, NO IMMEDIATE COMPLICATIONS APPRECIATED. NO PATIENT HARM REPORTED, BUT THERE WAS AN INCREASED RISK OF INFECTION RELATED TO MULTIPLE SITE ACCESS AND A DELAY IN CARE DUE TO EXTENDED PROCEDURE TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13252250 ↗
• MalfunctionJan 13, 2022Deformation Due to Compressive Stress; Deformation Due to Compressive Stress

  TWO GUIDEWIRES FAILED ON ONE PATIENT. INITIAL ATTEMPT AT LEFT FEMORAL CENTRAL LINE PLACEMENT COMPLICATED BY WIRE KINK. CANNULATION WAS SUCCESSFUL AND WIRE PLACEMENT CONFIRMED ON US HOWEVER ON DILATION CRITICAL KINK TO WIRE FORMED. PRESSURE HELD, NO IMMEDIATE COMPLICATIONS APPRECIATED. NO PATIENT HARM REPORTED, BUT THERE WAS AN INCREASED RISK OF INFECTION RELATED TO MULTIPLE SITE ACCESS AND A DELAY IN CARE DUE TO EXTENDED PROCEDURE TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13252207 ↗
• MalfunctionJan 13, 2022Deformation Due to Compressive Stress; Deformation Due to Compressive Stress

  CUSTOMER REPORTS GUIDEWIRE KINKS AND ANOTHER KIT HAD TO BE OPEN FOR A NEW WIRE. ALSO "HAD TO MOVE TO A SECOND SITE A FEW TIMES BECAUSE OF IT". NO PATIENT HARM REPORTED. THERE WAS A DELAY IN CARE RELATED TO EXTENDED PROCEDURE TIME AND IT WAS REPORTED THERE WAS AN INCREASED RISK OF INFECTION RELATED TO MULTIPLE SITE ACCESS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13252100 ↗
• MalfunctionJan 13, 2022Unraveled Material; Physical Resistance/Sticking; Unraveled Material; Physical Resistance/Sticking

  IT WAS REPORTED THREE GUIDEWIRES FAILED ON THE SAME PATIENT. THE GUIDEWIRE KINKS AND THEN THE COIL WIRE SEPARATES FROM THE SOLID WIRE. IT WAS REPORTED ON THE FIRST ATTEMPT IN THE LEFT IJ AND SECOND ATTEMPT IN RIGHT IJ, BOTH WIRES WERE DIFFICULT TO WITHDRAW. A THIRD ATTEMPT WAS SUCCESSFUL, HOWEVER, THE PATIENT GOT AGITATED AND PULLED THAT CATHETER OUT. A LEFT FEMORAL LINE WAS THEN ATTEMPTED, BUT NOT ABLE TO BE PLACED DUE TO WIRE MALFUNCTION. A RIGHT FEMORAL CATHETER WAS SUCCESSFULLY PLACED. NO PATIENT HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13252068 ↗
• MalfunctionJan 13, 2022Unraveled Material; Physical Resistance/Sticking; Unraveled Material; Physical Resistance/Sticking

  IT WAS REPORTED THREE GUIDEWIRES FAILED ON THE SAME PATIENT. THE GUIDEWIRE KINKS AND THEN THE COIL WIRE SEPARATES FROM THE SOLID WIRE. IT WAS REPORTED ON THE FIRST ATTEMPT IN THE LEFT IJ AND SECOND ATTEMPT IN RIGHT IJ, BOTH WIRES WERE DIFFICULT TO WITHDRAW. A THIRD ATTEMPT WAS SUCCESSFUL, HOWEVER, THE PATIENT GOT AGITATED AND PULLED THAT CATHETER OUT. A LEFT FEMORAL LINE WAS THEN ATTEMPTED, BUT NOT ABLE TO BE PLACED DUE TO WIRE MALFUNCTION. A RIGHT FEMORAL CATHETER WAS SUCCESSFULLY PLACED. NO PATIENT HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13251989 ↗
• MalfunctionJan 13, 2022Unraveled Material; Physical Resistance/Sticking; Unraveled Material; Physical Resistance/Sticking

  IT WAS REPORTED THREE GUIDEWIRES FAILED ON THE SAME PATIENT. THE GUIDEWIRE KINKS AND THEN THE COIL WIRE SEPARATES FROM THE SOLID WIRE. IT WAS REPORTED ON THE FIRST ATTEMPT IN THE LEFT IJ AND SECOND ATTEMPT IN RIGHT IJ, BOTH WIRES WERE DIFFICULT TO WITHDRAW. A THIRD ATTEMPT WAS SUCCESSFUL, HOWEVER, THE PATIENT GOT AGITATED AND PULLED THAT CATHETER OUT. A LEFT FEMORAL LINE WAS THEN ATTEMPTED, BUT NOT ABLE TO BE PLACED DUE TO WIRE MALFUNCTION. A RIGHT FEMORAL CATHETER WAS SUCCESSFULLY PLACED. NO PATIENT HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13251948 ↗
• MalfunctionDec 28, 2021Deformation Due to Compressive Stress; Physical Resistance/Sticking; Deformation Due to Compressive Stress; Physical Resistance/Sticking

  CUSTOMER REPORTS IT TOOK THREE ATTEMPTS TO PLACE A CENTRAL LINE IN THE PATIENT. ON THE FIRST ATTEMPT IN LEFT FEMORAL VEIN, THE WIRE WAS PLACED AND WHILE ATTEMPTING TO DILATE, THE WIRE BENT AND BECAME MALFORMED. THE CATHETER WOULD NOT PASS OVER THE WIRE. PROCEDURE WAS ABORTED AND SECOND ATTEMPT MADE IN RIGHT IJ. WHEN ATTEMPTING TO THREAD THE SECOND WIRE IT KINKED AND WOULD NOT ADVANCE THROUGH THE NEEDLE. PROCEDURE ABORTED AND THIRD ATTEMPT MADE IN RIGHT FEMORAL. THE THIRD WIRE KINKED WHILE ADVANCING THE CATHETER AND BECAME STUCK WITHIN THE CATHETER. WHEN TRYING TO REMOVE THE WIRE FROM THE CATHETER, THE WIRE FRAYED. THE WIRE WAS ABLE TO BE REMOVED AND THE USER WAS ABLE TO DRAW BLOOD FROM AND FLUSH ALL PORTS. NO PATIENT INJURY WAS REPORTED. THE PATIENT'S CONDITION IS REPORTED AS FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13095445 ↗
• MalfunctionDec 28, 2021Deformation Due to Compressive Stress; Physical Resistance/Sticking; Deformation Due to Compressive Stress; Physical Resistance/Sticking

  CUSTOMER REPORTS IT TOOK THREE ATTEMPTS TO PLACE A CENTRAL LINE IN THE PATIENT. ON THE FIRST ATTEMPT IN LEFT FEMORAL VEIN, THE WIRE WAS PLACED AND WHILE ATTEMPTING TO DILATE, THE WIRE BENT AND BECAME MALFORMED. THE CATHETER WOULD NOT PASS OVER THE WIRE. PROCEDURE WAS ABORTED AND SECOND ATTEMPT MADE IN RIGHT IJ. WHEN ATTEMPTING TO THREAD THE SECOND WIRE IT KINKED AND WOULD NOT ADVANCE THROUGH THE NEEDLE. PROCEDURE ABORTED AND THIRD ATTEMPT MADE IN RIGHT FEMORAL. THE THIRD WIRE KINKED WHILE ADVANCING THE CATHETER AND BECAME STUCK WITHIN THE CATHETER. WHEN TRYING TO REMOVE THE WIRE FROM THE CATHETER, THE WIRE FRAYED. THE WIRE WAS ABLE TO BE REMOVED AND THE USER WAS ABLE TO DRAW BLOOD FROM AND FLUSH ALL PORTS. NO PATIENT INJURY WAS REPORTED. THE PATIENT'S CONDITION IS REPORTED AS FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13095336 ↗
• MalfunctionDec 28, 2021Deformation Due to Compressive Stress; Deformation Due to Compressive Stress

  CUSTOMER REPORTS GUIDEWIRE KINKS AND ANOTHER KIT HAD TO BE OPEN FOR A NEW WIRE. ALSO "HAD TO MOVE TO A SECOND SITE A FEW TIMES BECAUSE OF IT". NO PATIENT HARM REPORTED. THERE WAS A DELAY IN CARE RELATED TO EXTENDED PROCEDURE TIME AND IT WAS REPORTED THERE WAS AN INCREASED RISK OF INFECTION RELATED TO MULTIPLE SITE ACCESS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13094005 ↗
• MalfunctionSep 27, 2021Deformation Due to Compressive Stress; Deformation Due to Compressive Stress

  CUSTOMER REPORTED WIRE KINKED UPON INSERTION. NO PATIENT HARM REPORTED. THE PATIENT'S CONDITION IS REPORTED AS FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12536935 ↗
• MalfunctionSep 27, 2021Deformation Due to Compressive Stress; Deformation Due to Compressive Stress

  CUSTOMER REPORTED WIRE KINKED UPON INSERTION. NO PATIENT HARM REPORTED. THE PATIENT'S CONDITION IS REPORTED AS FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12536919 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K071538. One submission often covers many models, so check the product and lot details in each record.

• Z-2376-2026 · Apr 21, 2026 · Open, Classified
  Description/REF: CVC/PSI KIT: 2 LUMEN 8 FR X 6 IN/ASK-42802-PLH; CVC KIT: 3-LUMEN 12 FR X 16 CM/AK-12123-F; CVC KIT: 3-LUMEN 12 FR X 20 CM/AK-15123-F; 3L CVC KIT: 7 FR X 16 CM/ASK-
• Z-1914-2026 · Mar 11, 2026 · Open, Classified
  ARROW, ARROWG+ARD AND ARROWG+ARD BLUE PLUS PRESSURE INJECTABLE CENTRAL VENOUS CATHETER REF ASK-42802-PLH UDI code: (01)10801902133110(17)261231(11)251211(10)33F25L0140 REF ASK-4
• Z-2123-2026 · Jan 7, 2026 · Open, Classified
  Medline Convenience Kits: 1) KIT TRIPLE LUMEN INSERTION, Model Number: DYNDM1031A
• Z-0003-2024 · Aug 10, 2023 · Open, Classified
  Arrow Pressure Injectable Arrowg+ard Blue Plus Four-Lumen CVC, REF CDC-45854-P1A; catheter, intravascular, therapeutic, long-term greater than 30 days
• Z-0002-2024 · Aug 10, 2023 · Open, Classified
  Arrow ErgoPack Complete, Pressure Injectable Arrowg+ard Blue Plus Four-Lumen CVC, REF CDC-42854- PCN1A; catheter, intravascular, therapeutic, long-term greater than 30 days
• Z-0352-2023 · Oct 27, 2022 · Terminated
  Pressure Injectable Arrowg+ard Blue Plus Three-Lumen CVC Kit, REF numbers: a) ASK-42703-NS, b) ASK-42703-PCCH2, c) ASK-42703-PUPM1, d) ASK-45703-NS, e) ASK-45703-PAU, f) ASK-45703-
• Z-0351-2023 · Oct 27, 2022 · Terminated
  Arrow MAC Two-Lumen Central Venous Access Kit fr use with 7 - 7.5 Fr Catheters, REF ASK-11242-UPM1; catheter introducer
• Z-1604-2022 · May 25, 2022 · Open, Classified
  TELEFLEX LLC Arrow Central Venous Catheter Kit 16, 18 Gauge Multi Lumen Model Number:CDC-45703-XP1A (Model Numbers # IPN035619, IPN036437, IPN922677)
• Z-1995-2018 · Apr 11, 2018 · Terminated
  Pressure Injectable Multi-Lumen Central Venous Catheterization Kit with Blue FlexTip, ARROWg+ard Blue PLUS Catheter, Sharps Safety Features and Maximal Barrier Precautions; Product
• Z-1990-2018 · Apr 11, 2018 · Terminated
  Pressure Injectable Two-Lumen Central Venous Catheterization Kit with Blue FlexTip(R), ARROWg+ard Blue PLUS(R) Catheter and Sharps Safety Features; Product Code: ASK-45802-PHMW
• Z-1987-2018 · Apr 11, 2018 · Terminated
  Multi-Lumen Central Venous Catheterization Kit with Blue FlexTip(R), ARROWg+ard Blue PLUS(R) Catheter and Sharps Safety Features; Product Codes: ASK-42703-MHW and ASK-42703-OLL1
• Z-1993-2018 · Apr 11, 2018 · Terminated
  Pressure Injectable ARROWg+ard Blue PLUS(R) Two-Lumen Central Venous Catheterization Kit; Product Code: ASK-42802-PWHC1
• Z-1998-2018 · Apr 11, 2018 · Terminated
  Multi-Lumen Central Venous Catheterization Kit with Blue FlexTip(R), ARROWg+ard Blue PLUS(R) Catheter, Sharps Safety Features and Maximal Barrier Precautions; Product Code: ASK-427
• Z-1996-2018 · Apr 11, 2018 · Terminated
  Pressure Injectable Multi-Lumen Central Venous Catheterization Kit with Blue FlexTip(R), ARROWg+ard Blue PLUS(R) Catheter, Sharps Safety Features and Maximal Barrier Precautions; P
• Z-1981-2018 · Apr 11, 2018 · Terminated
  Pressure Injectable Multi-Lumen Central Venous Catheterization Kit; Product Code: ASK-15703-PVH and ASK-15703-PNYP

…and 39 more.