ARROW IPN036455Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 30801902117275), received between Aug 29, 2019 and Oct 10, 2023 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Wrong Label” (5 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-2394-2026 · Root cause: Nonconforming Material/Component · FDA record ↗

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 10, 2023Material Separation; Material Separation

  IT WAS REPORTED THE CATHETER WAS PLACED ON (B)(6) 2023 THE LUMEN SEPARATED. "PRIMARY RN ENTERED PATIENT'S ROOM IN RESPONSE TO BED-FALL ALARM. PATIENT WAS AMBULATING TO RESTROOM AT THAT TIME. PRIMARY RN ASSISTED PATIENT TO RESTROOM. IT WAS NOTED THAT PATIENT'S IV TUBING WAS NO LONGER CONNECTED TO HIS CVC. IT IS UNCLEAR WHAT CAUSED THE LINE TO FAIL. UPON ASSESSING HIS IV LINE, IT WAS NOTED THAT THE LUMEN WITH HEPARIN INFUSION HAD BROKEN. PATIENT'S CENTRAL LINE WAS ASSESSED BY PRIMARY RN, CHARGE RN, AND RESOURCE RN. TUBING FOUND TO BE BROKEN APART IN SUCH A WAY THAT IT CANNOT BE REPAIRED OR RECONNECTED. TUBING WAS CLAMPED, AND EXPOSED TUBING WAS COVERED WITH A STERILE DRESSING AND ANTIMICROBIAL CAP." THE CATHETER WAS REMOVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17904177 ↗
• MalfunctionJun 13, 2023Wrong Label; Wrong Label

  IT WAS REPORTED THE CUSTOMER RECEIVED SHIPMENT OF 1 CASE THAT WAS LABELED CDC-45854-P1A ON THE CORRAGATE BOX, HOWEVER INSIDE THE CASE WAS PRODUCT FOR ASK-11142-NSU. THE LIDSTOCK ON THE PRODUCT WAS NOTED TO BE INCORRECT. NO PATIENT INVOLVEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17122550 ↗
• MalfunctionJun 13, 2023Wrong Label; Wrong Label

  IT WAS REPORTED THE CUSTOMER RECEIVED SHIPMENT OF 1 CASE THAT WAS LABELED CDC-45854-P1A ON THE CORRAGATE BOX, HOWEVER INSIDE THE CASE WAS PRODUCT FOR ASK-11142-NSU. THE LIDSTOCK ON THE PRODUCT WAS NOTED TO BE INCORRECT. NO PATIENT INVOLVEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17122548 ↗
• MalfunctionJun 13, 2023Wrong Label; Wrong Label

  IT WAS REPORTED THE CUSTOMER RECEIVED SHIPMENT OF 1 CASE THAT WAS LABELED CDC-45854-P1A ON THE CORRAGATE BOX, HOWEVER INSIDE THE CASE WAS PRODUCT FOR (B)(6). THE LIDSTOCK ON THE PRODUCT WAS NOTED TO BE INCORRECT. NO PATIENT INVOLVEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17122533 ↗
• MalfunctionJun 13, 2023Wrong Label; Wrong Label

  IT WAS REPORTED THE CUSTOMER RECEIVED SHIPMENT OF 1 CASE THAT WAS LABELED CDC-45854-P1A ON THE CORRAGATE BOX, HOWEVER INSIDE THE CASE WAS PRODUCT FOR ASK-11142-NSU. THE LIDSTOCK ON THE PRODUCT WAS NOTED TO BE INCORRECT. NO PATIENT INVOLVEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17122530 ↗
• MalfunctionJun 13, 2023Wrong Label; Wrong Label

  IT WAS REPORTED THE CUSTOMER RECEIVED SHIPMENT OF 1 CASE THAT WAS LABELED CDC-45854-P1A ON THE CORRAGATE BOX, HOWEVER INSIDE THE CASE WAS PRODUCT FOR ASK-11142-NSU. THE LIDSTOCK ON THE PRODUCT WAS NOTED TO BE INCORRECT. NO PATIENT INVOLVEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17122516 ↗
• MalfunctionAug 29, 2019Material Integrity Problem

  TIP OF CATHETER IS GETTING STRIPPED. POTENTIAL FOR VASCULAR DAMAGE. 8.5 FRENCH, 20 CM., 0.032 INCH DIAMETER SPRING WIRE GUIDE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8944487 ↗

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-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-1979-2018 · Apr 11, 2018 · Terminated
  Pressure Injectable Multi-Lumen Central Venous Catheterization Kit with Blue FlexTip(R) Catheter, Sharps Safety Features and Maximal Barrier Precautions; Product Code: ASK-15703-LD
• 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-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-1992-2018 · Apr 11, 2018 · Terminated
  ARROWg+ard Blue PLUS Pressure Injectable Two-Lumen CVC Kit; Product Code: CDC-42802-P1A
• 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

…and 39 more.