ARROW IPN915619Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10801902162042), received between Jun 20, 2023 and Jun 25, 2025 — classified as 1 death, 8 malfunctions.

The most frequently reported specific device problem is “Material Puncture/Hole” (2 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 25, 2025Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED "HOLE DISCOVERED DURING INSERTION, AN OVER THE WIRE EXCHANGE WAS PERFORMED WITHOUT 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 22329491 ↗
• MalfunctionMay 28, 2025Improper Flow or Infusion; Improper Flow or Infusion

  IT WAS REPORTED" MY INFECTION CONTROL/VASCULAR TEAM DIRECTOR, JUST BROUGHT ME A CATHETER AND TOLD ME THAT WHEN THE PHYSICIAN WENT TO FLUSH ONE OF THE LUMENS THE FLUSH WENT BACK UP INTO ONE OF THE OTHER LUMENS INSTEAD OF DOWN THE CATHETER." THE CATHETER WAS REMOVED AND REPLACED. 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 22095156 ↗
• MalfunctionApr 9, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED "MADE AWARE TODAY, OF A PATIENT'S ATTEMPT TO REMOVE IJ TRIPLE LUMEN CVC LINE, WITH DAMAGE DONE TO ALL 3 LUMENS/PIGTAILS. ICU ATTENDING MD REMOVED SUTURES. THE ACTUAL CVC HAD TO BE CLAMPED, AND WAS THEN REMOVED WITHOUT INCIDENT, AND A SECOND TRIPLE LUMEN CVC WAS PLACED WITHOUT ISSUE." ADDITIONAL INFORMATION RECEIVED REPORTS "THE DAMAGE DONE TO ALL 3 LUMENS/PIGTAILS IS REFERRING TO THE EXTENSION LINES BEING DAMAGED. ALL THREE EXTENSION LINES WERE ALMOST TORN COMPLETELY AWAY, WITH TWO HAVING REMNANTS OF THE TUBING STILL INTACT WHERE THE DISTAL PORTION MEETS/ADHERES TO THE JUNCTION. THE OTHER ONE WAS COMPLETELY REMOVED FROM THE JUNCTION HUB WITH NO REMNANTS VISIBLE. THE LUER-HUBS OF ALL THREE EXTENSION LINES, WERE COMPLETELY BROKEN OFF, AND NO LONGER AVAILABLE OR VISIBLE." 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 21808459 ↗
• MalfunctionOct 2, 2024Dent in Material; Difficult to Advance; Dent in Material; Difficult to Advance

  IT WAS REPORTED "UNABLE TO PASS WIRE, DENT/MARK NOTED AT 16CM." THE USER CHANGED TO A NEW SET. 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 20350806 ↗
• MalfunctionMar 8, 2024Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT: INSERTER OPENED THE PACKAGE AND NOTICED THAT THE J TIP OF THE WIRE WAS ALMOST COMPLETELY SEPARATED FROM THE REST OF THE WIRE. THE ISSUE WAS IDENTIFIED PRIOR TO USE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18864463 ↗
• MalfunctionMar 6, 2024Material Puncture/Hole; Material Puncture/Hole

  THE REPORT STATES: WHEN FLUSHING A LUMEN OF THE PATIENTS TRIPLE LUMEN INTERNAL JUGULAR (IJ) CENTRAL VENOUS CATHETER (CVC), SALINE BEGAN LEAKING OUT. A HOLE WAS NOTED IN THE LUMEN. THE REPORTED DEFECT WAS DETECTED: AT PRETEST. ADDITIONAL INFORMATION: THERE WAS NO REPORTED PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18846874 ↗
• MalfunctionFeb 21, 2024Material Deformation; Material Deformation

  IT WAS REPORTED "AFTER THE LINE WITH THE BROWN CAP WAS USED FOR CT WITH CONTRAST THE LINE BECAME FLAT. THE ICU TEAM REMOVED THE CENTRAL LINE AND INSERTED A NEW ONE. THERE WAS NO HARM TO THE PATIENT." NO MEDICAL INTERVENTION REQUIRED. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18748218 ↗
• MalfunctionOct 24, 2023Deformation Due to Compressive Stress; Deformation Due to Compressive Stress

  IT WAS REPORTED "WIRE BROKEN" PRIOR TO USE. NO PATIENT INVOLVEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17999003 ↗
• DeathJun 20, 2023Unraveled Material; Unraveled Material

  CUSTOMER REPORTED "PRODUCT WAS PULLED OUT OF PATIENT AND PRODUCT WAS FRAYED WHEN REMOVED". IT WAS REPORTED IT WAS FOUND "FRAYED/UNRAVELED UPON WITHDRAWING DILATOR". THE INSERTION SITE WAS THE RIGHT IJ. THE SURGEON DID A CUT DOWN TO REMOVE THE GUIDEWIRE. AFTER THE WIRE WAS REMOVED, A NEW LINE WAS INSERTED IN A SITE JUST BELOW THE FIRST. THE CUSTOMER REPORTED "THIS INCIDENT DID NOT APPEAR TO AFFECT THE OVERALL CONDITION OF THE PATIENT." THE PATIENT'S CONDITION WAS REPORTED TO BE DECEASED ON (B)(6) 2023 AT 1823. THE CAUSE OF DEATH WAS REPORTED AS SEPSIS AND NSTEMI. THE PATIENT'S UNDERLYING DISEASE INCLUDED CARDIOPULMONARY ARREST, ACUTE PULMONARY EDEMA, AND ANOXIC BRAIN INJURY.

  Patient problems: Foreign Body In Patient

  MAUDE report 17164413 ↗

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-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-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-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-1994-2018 · Apr 11, 2018 · Terminated
  ARROWg+ard Blue PLUS Pressure Injectable Multi-Lumen CVC Kit; Product Codes: CDC-45703-P1A; CDC-45703-PB1A; CDC-42703-P1A; and CDC-15703-P1A
• 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-2000-2018 · Apr 11, 2018 · Terminated
  ARROWg+ard Blue PLUS(R) Multi-Lumen Central Venous Catheterization Kit; Product Code: ASK-42703-SJH
• Z-1999-2018 · 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-1980-2018 · Apr 11, 2018 · Terminated
  Pressure Injectable Multi-Lumen Central Venous Catheterization Kit; Product Code: ASK-15703-PHMC
• Z-1981-2018 · Apr 11, 2018 · Terminated
  Pressure Injectable Multi-Lumen Central Venous Catheterization Kit; Product Code: ASK-15703-PVH and ASK-15703-PNYP
• 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

…and 39 more.