ARROW IPN036440 (REF CDC-42703-XP1A)Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10801902117080), received between Sep 25, 2023 and Nov 12, 2025 — classified as 1 injury, 5 malfunctions.

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

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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryNov 12, 2025Material Separation; Material Separation

  IT WAS REPORTED "THE CATHETER BROKE OFF FROM THE BASE/TIP WITH NO RESISTANCE AND COULD NOT BE RETRIEVED UNDER THE PATIENT'S SKIN." THE CATHETER WAS REMOVED BY IR RETRIEVAL. THERE WAS NO SIGNS OR SYMPTOMS AFTER THE EVENT. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "STABLE AND DISCHARGED HOME".

  Patient problems: Foreign Body In Patient

  MAUDE report 23532416 ↗
• MalfunctionApr 24, 2024Connection Problem; Connection Problem

  IT WAS REPORTED "THE INTRODUCER NEEDLE SLIDES OFF THE SYRINGE IF GEL OR BLOOD GETS ON IT. THE INTRODUCER NEEDLE DOES NOT STAY STATIONARY WHEN PLACE ON THE SYRINGE". ADDITIONAL INFORMATION WAS REQUESTED FROM THE CUSTOMER, NO ADDITIONAL INFORMATION AVAILABLE AT THIS TIME.

  Patient problems: Insufficient Information

  MAUDE report 19172911 ↗
• MalfunctionMar 13, 2024Unraveled Material; Material Twisted/Bent; Unraveled Material; Material Twisted/Bent

  IT WAS REPORTED "SPRING WIRE GUIDE KINKS EASILY". NO MEDICAL INTERVENTION REQUIRED. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE". ASSOCIATED MDR NUMBERS INCLUDE: 9680794-2024-00226, 9680794-2024-00227, AND 9680794-2024-00225.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18893813 ↗
• MalfunctionMar 13, 2024Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED "SPRING WIRE GUIDE KINKS EASILY". NO MEDICAL INTERVENTION REQUIRED. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE". ASSOCIATED MDR NUMBERS INCLUDE: 9680794-2024-00226, 9680794-2024-00310, 9680794-2024-00227.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18893723 ↗
• MalfunctionSep 25, 2023Material Separation; Material Separation

  MEDWATCH REPORT RECEIVED: "ON (B)(6) 2023 THIS PATIENT HAD A 20CM LEFT SUBCLAVIAN CVC PLACED BY IR. IT FUNCTIONED PROPERLY, UNTIL (B)(6) 2023 WHEN RN HEARD A LITTLE POP AND SAW THAT THE DISTAL LUMEN HAD COME OFF AT THE PLASTIC BROWN PART AND BLOOD WAS LEAKING OUT. RN CLAMPED LINE AND TIED A KNOT IN THE LUMEN. MD CONTACTED AND CENTRAL LINE WAS REMOVED. REF REPORT: MW5120619." NO PATIENT HARM WAS REPORTED. THE CVC WAS REMOVED AND A NEW ONE PLACED. THE PATIENT'S CONDITION IS REPORTED AS "STABLE".

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 17810220 ↗
• MalfunctionSep 25, 2023Material Separation; Material Separation

  MEDWATCH REPORT RECEIVED: "ON (B)(6) 2023 THIS PATIENT HAD A 20CM LEFT SUBCLAVIAN CVC PLACED BY IR. IT FUNCTIONED PROPERLY, UNTIL (B)(6) 2023 WHEN RN HEARD A LITTLE POP AND SAW THAT THE DISTAL LUMEN HAD COME OFF AT THE PLASTIC BROWN PART AND BLOOD WAS LEAKING OUT. RN CLAMPED LINE AND TIED A KNOT IN THE LUMEN. MD CONTACTED AND CENTRAL LINE WAS REMOVED. REF REPORT: MW5120620." NO PATIENT HARM WAS REPORTED. THE CVC WAS REMOVED AND A NEW ONE PLACED. THE PATIENT'S CONDITION IS REPORTED AS "STABLE".

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 17809843 ↗

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-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-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-2000-2018 · Apr 11, 2018 · Terminated
  ARROWg+ard Blue PLUS(R) Multi-Lumen Central Venous Catheterization Kit; Product Code: ASK-42703-SJH
• 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-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
• 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-1980-2018 · Apr 11, 2018 · Terminated
  Pressure Injectable Multi-Lumen Central Venous Catheterization Kit; Product Code: ASK-15703-PHMC

…and 39 more.