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ARROW IPN915628Recalls & reported problems

Teleflex Incorporated · Pressure Injectable Arrowg+ard Blue Plus(R) Four-Lumen CVC · Class 2

2 open recalls name this device. See the recall details and contact the manufacturer or your healthcare provider.

Adverse event reports
5
Deaths reported
0
Injuries reported
0
Recalls naming it
2

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10801902162134), received between Jun 26, 2023 and Jun 28, 2023 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Wrong Label” (5 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-2384-2026 · 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

Device problems

  • Wrong Label5

Patient problems

  • No Clinical Signs, Symptoms or Conditions5

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

  • MalfunctionJun 28, 2023Wrong Label; Wrong Label

    IT WAS REPORTED "THEY PULLED THE KIT AND NOTICED THE BANNER DIDN'T MATCH THE LABEL ON THE TOP OF THE KIT". NO PATIENT INVOLVEMENT WAS REPORTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 17216593 ↗
  • MalfunctionJun 28, 2023Wrong Label; Wrong Label

    IT WAS REPORTED "THEY PULLED THE KIT AND NOTICED THE BANNER DIDN'T MATCH THE LABEL ON THE TOP OF THE KIT". NO PATIENT INVOLVEMENT WAS REPORTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 17216576 ↗
  • MalfunctionJun 28, 2023Wrong Label; Wrong Label

    IT WAS REPORTED "THEY PULLED THE KIT AND NOTICED THE BANNER DIDN'T MATCH THE LABEL ON THE TOP OF THE KIT". NO PATIENT INVOLVEMENT WAS REPORTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 17216504 ↗
  • MalfunctionJun 28, 2023Wrong Label; Wrong Label

    IT WAS REPORTED "THEY PULLED THE KIT AND NOTICED THE BANNER DIDN'T MATCH THE LABEL ON THE TOP OF THE KIT". NO PATIENT INVOLVEMENT WAS REPORTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 17216393 ↗
  • MalfunctionJun 26, 2023Wrong Label; Wrong Label

    IT WAS REPORTED "WRONG LABELING ON PACKAGING. TOP LABEL SHOWS A TRIPLE LUMEN, INSIDE PACKAGING SHOWS A QUAD LUMEN. A QUAD LUMEN IS IN THE KIT." THE USER PLACED THE QUAD LUMEN. NO PATIENT HARM WAS REPORTED. THE PATIENT'S CONDITION IS REPORTED AS FINE.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 17198998 ↗

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-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-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-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-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-1981-2018 · Apr 11, 2018 · Terminated
    Pressure Injectable Multi-Lumen Central Venous Catheterization Kit; Product Code: ASK-15703-PVH and ASK-15703-PNYP
  • Z-1992-2018 · Apr 11, 2018 · Terminated
    ARROWg+ard Blue PLUS Pressure Injectable Two-Lumen CVC Kit; Product Code: CDC-42802-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
  • 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

…and 38 more.

Other Catheter, intravascular, therapeutic, short-term less than 30 days devices

All Catheter, intravascular, therapeutic, short-term less than 30 days devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.