ARROW IPN035619 (REF CDC-45703-XP1A)Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10801902058611), received between Mar 4, 2021 and Jun 21, 2021 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Material Separation” (1 report).

1 FDA recall record name this device's identifier, 1 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Recalls naming this device

1. May 25, 2022Open, Classified

   Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. All lots received between 06/01/21-9/30/21.

   Z-1604-2022 · Root cause: Environmental control · Recall details · FDA record ↗

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 21, 2021Material Separation; Material Separation

  IT WAS REPORTED THE PATIENT SOMEHOW PULLED THE BROWN PORT AND LINE FROM HER CENTRAL LINE. THERE WAS NO BLEEDING OR OBVIOUS AIR EMBOLI THAT OCCURRED. THE LINE WAS PROMPTLY REMOVED AND REPLACED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12031218 ↗
• MalfunctionMay 4, 2021Unraveled Material; Unraveled Material

  THE COMPLAINT IS REPORTED AS: DURING INSETION THE PHYSICIAN BEGAN ADVANCING THE SPRING WIRE GUIDE, THE "COIL BLOWS UP" (UNRAVELED) AND THEY REMOVED THE ENTIRE CATHETER AND WIRE. DID NOT PURSUE INSERTING CENTRAL LINE AT THE TIME. THERE WAS NO INJURY OR HARM TO THE PATIENT AS A RESULT OF THE DEVICE, BUT THERAPY WAS DELAYED. THE PATIENT'S CONDITION WAS REPORTED AS CRITICAL, UNRELATED TO THE DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11772901 ↗
• InjuryMar 4, 2021Obstruction of Flow; Obstruction of Flow

  THE COMPLAINT IS REPORTED AS: THE NURSE NOTED SWELLING ON THE PATIENT'S RIGHT SIDE OF THE NECK AND SHOULDER AND NOTIFIED THE PHYSICIAN. THE PHYSICIAN RECOMMENDED MONITORING OF SITE. PATIENT NOTED TO HAVE HYPOTENSION DESPITE BEING ON PRESSORS AND WORSENING SWELLING AND REDDISH DISCOLORATION OF SKIN. THE PHYSICIAN WAS NOTIFIED, BUT NO ORDERS WERE GIVEN. THE CENTRAL LINE WAS THEN REPORTED TO BE CLOTTED AND UNABLE TO INFUSE THE PRESSORS. THE PATIENT'S SYSTOLIC BLOOD PRESSURE WAS REPORTED TO BE 90. THE PRESSORS WERE SWITCH TO THE PATIENT'S PORT-A-CATH AND THE SYSTOLIC BLOOD PRESSURE INCREASED SUDDENLY TO THE 200S. EPINEPHRINE AND NEOSYNEPHRINE WERE STOPPED. THE USER TRIED TO DRAW BACK FROM THE CATHETER BUT WAS UNABLE TO. THE PHYSICIAN WAS INFORMED AND EXTRAVASATION SUSPECTED. A CHEST X-RAY WAS PERFORMED AND THE PATIENT WAS TREATED WITH TERBUTALINE. A NEW CENTRAL LINE WAS INSERTED IN THE LEFT IJ AND THE RIGHT SC CENTRAL LINE WAS DISCONTINUED. THE PATIENT'S CONDITION WAS REPORTED TO BE FINE.

  Patient problems: Extravasation

  MAUDE report 11415050 ↗

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-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-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-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-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-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-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-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

…and 38 more.