ARROW IPN055401Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10801902156225), received between Jun 18, 2024 and Jun 25, 2024 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 25, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED "ON 5/29 THE NURSE WAS DOING HER AM LINE ASSESSMENT AND NOTICED THE GOWN/SHOULDER AREA OF THE PATIENT, SAME SIDE AS CATHETER WAS PLACED, WAS WET. THE NURSE THEN NOTICED LEAKING WAS COMING FROM THE MICROCLAVE NEUTRAL DISPLACEMENT CONNECTORS, THAT COME IN THE KIT, & WERE ATTACHED TO THE LUMEN HUBS. BECAUSE THESE CONNECTORS APPEARED TO BE CRACKED AND LEAKING, NOT SURE IF ALL (4) WERE AFFECTED, THE RN CHANGED ALL 4 FROM SINGLE STERILE INVENTORY, AND THE ISSUE WAS RESOLVED." THERE WAS NO PATIENT HARM OR INJURY. NO MEDICAL INTERVENTION REQUIRED. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE". ASSOCIATED MDR NUMBERS INCLUDE: 9680794-2024-00636, 9680794-2024-00607, AND 9680794-2024-00661.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19605728 ↗
• MalfunctionJun 25, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED "ON 5/29 THE RN WAS DOING HER AM LINE ASSESSMENT AND NOTICED THE GOWN/SHOULDER AREA OF THE PATIENT, SAME SIDE AS CATHETER WAS PLACED, WAS WET. RN THEN NOTICED LEAKING WAS COMING FROM THE MICROCLAVE NEUTRAL DISPLACEMENT CONNECTORS, THAT COME IN THE KIT, & WERE ATTACHED TO THE LUMEN HUBS. BECAUSE THESE CONNECTORS APPEARED TO BE CRACKED AND LEAKING, NOT SURE IF ALL (4) WERE AFFECTED, THE RN CHANGED ALL 4 FROM SINGLE STERILE INVENTORY, AND THE ISSUE WAS RESOLVED." THERE WAS NO PATIENT HARM OR INJURY. NO MEDICAL INTERVENTION REQUIRED. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE". ASSOCIATED MDR NUMBERS INCLUDE: 9680794-2024-00637, 9680794-2024-00607, AND 9680794-2024-00661.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19605672 ↗
• MalfunctionJun 18, 2024Crack; Fluid/Blood Leak; Crack; Fluid/Blood Leak

  IT WAS REPORTED "ON (B)(6) THE RN WAS DOING HER AM LINE ASSESSMENT AND NOTICED THE GOWN/SHOULDER AREA OF THE PATIENT, SAME SIDE AS CATHETER WAS PLACED, WAS WET. RN THEN NOTICED LEAKING WAS COMING FROM THE MICROCLAVE NEUTRAL DISPLACEMENT CONNECTORS, THAT COME IN THE KIT, & WERE ATTACHED TO THE LUMEN HUBS. BECAUSE THESE CONNECTORS APPEARED TO BE CRACKED AND LEAKING, NOT SURE IF ALL (4) WERE AFFECTED, THE RN CHANGED ALL 4 FROM SINGLE STERILE INVENTORY, AND THE ISSUE WAS RESOLVED." THERE WAS NO PATIENT HARM OR INJURY. NO MEDICAL INTERVENTION REQUIRED. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE". ASSOCIATED MDR NUMBERS INCLUDE: 9680794-2024-00637, 9680794-2024-00636, AND 9680794-2024-00607.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19558052 ↗

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-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-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-1980-2018 · Apr 11, 2018 · Terminated
  Pressure Injectable Multi-Lumen Central Venous Catheterization Kit; Product Code: ASK-15703-PHMC
• Z-1989-2018 · Apr 11, 2018 · Terminated
  ARROWg+ard Blue PLUS Pressure Injectable Quad-Lumen CVC Kit; Product Codes: CDC-42854-P1A and CDC-45854-P1A
• Z-2000-2018 · Apr 11, 2018 · Terminated
  ARROWg+ard Blue PLUS(R) Multi-Lumen Central Venous Catheterization Kit; Product Code: ASK-42703-SJH
• 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

…and 39 more.