ARROW IPN036445Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10801902116793), received between May 18, 2021 and Jun 23, 2025 — classified as 8 malfunctions.

The most frequently reported specific device problem is “Unraveled Material” (3 reports).

2 FDA recall records name this device's identifier, 2 still open.

53 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-2388-2026 · Root cause: Nonconforming Material/Component · FDA record ↗

2. 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-2376-2026 · Root cause: Nonconforming Material/Component · FDA record ↗

Most reported problems

Recent adverse event reports

The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 23, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED "TRIPLE LUMEN CENTRAL LINE PLACED (B)(6) 2025. PATIENT TRANSFERRED TO CH. LINE REMOVED (B)(6) 2025 AFTER DETERMINING THE EXTENSION LINE WAS LEAKING. A SMALL HOLE WAS FOUND IN THE CATHETER." THE LINE WAS REMOVED AS IT WAS NO LONGER NEEDED. 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 22309357 ↗
• MalfunctionMay 6, 2025Unraveled Material; Physical Resistance/Sticking; Unraveled Material; Physical Resistance/Sticking

  IT WAS REPORTED THAT "RAPID RESPONSE WAS CALLED BY MED SURG. DR. RESPONDED FROM ED, WHO ATTEMPTED TO INSERT CENTRAL LINE, HE WAS UNABLE TO DO SO BECAUSE OF GUIDEWIRE FAILURE, IT CAME UNCOILED AND UNTHREADED. THERE WERE 2 UNSUCCESSFUL ATTEMPTS FOR INSERTING CENTRAL LINE, AT RIGHT IJ AND RIGHT FEMORAL, SAME ISSUE HAPPENED TWICE." ADDITIONAL INFORMATION RECEIVED FROM THE PHYSICIAN STATES ". I HELD OFF ON ATTEMPTING ANOTHER PLACEMENT OF THE CENTRAL LINE SINCE THE PATIENT DID HAVE 2 PERIPHERAL IVS AND A IO." THERE WAS NO PATIENT HARM OR INJURY BUT THE TEAM WAS UNABLE TO GET CVC LINE ACCESS IN THE PATIENT. NO MEDICAL INTERVENTION REQUIRED. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "IN CRITICAL CONDITION". ASSOCIATED MDR NUMBERS INCLUDE: 9680794-2025-00377.

  Patient problems: Insufficient Information

  MAUDE report 21967557 ↗
• MalfunctionMay 6, 2025Unraveled Material; Physical Resistance/Sticking; Unraveled Material; Physical Resistance/Sticking

  IT WAS REPORTED THAT "RAPID RESPONSE WAS CALLED BY MED SURG. DR. RESPONDED FROM ED, WHO ATTEMPTED TO INSERT CENTRAL LINE, HE WAS UNABLE TO DO SO BECAUSE OF GUIDEWIRE FAILURE, IT CAME UNCOILED AND UNTHREADED. THERE WERE 2 UNSUCCESSFUL ATTEMPTS FOR INSERTING CENTRAL LINE, AT RIGHT IJ AND RIGHT FEMORAL, SAME ISSUE HAPPENED TWICE." ADDITIONAL INFORMATION RECEIEVED FROM THE PHYSICIAN STATES ". I HELD OFF ON ATTEMPTING ANOTHER PLACEMENT OF THE CENTRAL LINE SINCE THE PATIENT DID HAVE 2 PERIPHERAL IVS AND A IO." THERE WAS NO PATIENT HARM OR INJURY BUT THE TEAM WAS UNABLE TO GET CVC LINE ACCESS IN THE PATIENT. NO MEDICAL INTERVENTION REQUIRED. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "IN CRITICAL CONDITION". ASSOCIATED MDR NUMBERS INCLUDE: 9680794-2025-00376.

  Patient problems: Insufficient Information

  MAUDE report 21967546 ↗
• MalfunctionFeb 26, 2024Material Separation; Material Separation

  IT WAS REPORTED "PATIENT WAS CODING, THERE WAS A LOT OF ACTIVITY IN THE ROOM, AND THEY WERE TURNING THE PATIENT AND THE CATHETER SLIPED RIGHT OUT OF THE HUB AND WAS LAYING ON THE FLOOR." NEW VASCULAR ACCESS OBTAINED. NO MEDICAL INTERVENTION REQUIRED. THE PATIENTS CURRENT CONDITION IS REPORTED AS "FINE". NO PATIENT INJURY OR CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18778929 ↗
• MalfunctionSep 12, 2022Stretched; Stretched

  MEDWATCH RECEIVED REPORTS "CENTRAL LINE BALLOONED OUT WHILE IT WAS INSERTED IN THE PATIENT". ADDITIONAL INFORMATION WAS REQUESTED BUT WAS NOT AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: Insufficient Information

  MAUDE report 15402317 ↗
• MalfunctionAug 19, 2022Material Deformation; Positioning Problem

  CENTRAL LINE BALLOONED OUT WHILE IT WAS INSERTED IN THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15257924 ↗
• MalfunctionMay 19, 2021Leak/Splash; Leak/Splash

  CUSTOMER REPORTS WHEN INITIALLY INSERTING THE ENTRY NEEDLE/CATHETER AND PULLING BACK FOR BLOOD TO CONFIRM PLACEMENT THEY ARE GETTING A FLASH OR BLOOD AND THEN JUST AIR. CUSTOMER REPORTS THEY CONFIRMED THEY ARE IN THE ARTERY VIA ULTRASOUND AND ARE ONLY GETTING BLOOD RETURN WHEN THEY DISCONNECT THE SYRINGE. NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11853032 ↗
• MalfunctionMay 18, 2021Unraveled Material; Unraveled Material

  CUSTOMER REPORTED RESISTANCE WHEN REMOVING THE GUIDEWIRE AND "SAW THAT THE OUTER WIRE WOUND PORTION WAS UNRAVELING". THE WIRE WAS SLOWLY REMOVED FROM THE PATIENT. CUSTOMER REPORTED THERE WAS A BEND ABOUT HALFWAY THROUGH THE WIRE. NO PATIENT HARM WAS REPORTED. THE PATIENT'S CONDITION WAS REPORTED AS CRITICAL UNRELATED TO THE DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11842838 ↗

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-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-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-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-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-1997-2018 · Apr 11, 2018 · Terminated
  Pressure Injectable Multi-Lumen Central Venous Catheterization Kit with Blue FlexTip(R), ARROWg+ard Blue PLUS(R) Catheter and Sharps Safety Features; Product Codes: ASK-42703-PTJH
• Z-1980-2018 · Apr 11, 2018 · Terminated
  Pressure Injectable Multi-Lumen Central Venous Catheterization Kit; Product Code: ASK-15703-PHMC
• 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-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-1991-2018 · Apr 11, 2018 · Terminated
  Pressure Injectable Quad-Lumen Central Venous Catheterization Kit with Blue FlexTip(R), ARROWg+ard Blue PLUS(R) Catheter and Sharps Safety Features; Product Codes: ASK-45854-PSFM a
• 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-1988-2018 · Apr 11, 2018 · Terminated
  Pressure Injectable ARROWg+ard Blue PLUS(R) Multi-Lumen Central Venous Catheterization Kit; Product Codes: ASK-42703-PAM1, ASK-42703-PSHR1, ASK-45703-PNY, ASK-45703-PWHC1

…and 38 more.