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 20801902117087), received between May 19, 2021 and Mar 29, 2024 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Deformation Due to Compressive Stress” (2 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-2384-2026 · Root cause: Nonconforming Material/Component · FDA record ↗

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.

• MalfunctionMar 29, 2024

  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.

  Patient problems: Insufficient Information

  MAUDE report 19002981 ↗
• MalfunctionSep 30, 2022Material Separation; Material Separation

  IT WAS REPORTED ON 13JUL2022, THE FEMALE LUER LOCK HUB ON THE END OF THE LUMEN CAME OFF. THE LUMEN HAD TO BE CLAMPED AND THE CATHETER WAS REPLACED. NO MEDICAL INTERVENTION WAS REPORTED, AND THERE WAS NO PATIENT INJURY OR CONSEQUENCE REPORTED. THE PATIENT'S CURRENT CONDITION IS REPORTED AS FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15520591 ↗
• MalfunctionOct 22, 2021Deformation Due to Compressive Stress; Deformation Due to Compressive Stress

  PHYSICIAN REPORTS GUIDEWIRE KINKING DURING THE PROCEDURE (90 DEGREE KINK). THE GUIDEWIRE HAD TO BE PULLED OUT OF THE PATIENT ALONG WITH THE INTRODUCER NEEDLE. THERE WAS NO PATIENT INJURY. THE PROCEDURE WAS COMPLETED WITH ANOTHER KIT. THE PATIENT'S CONDITION IS REPORTED AS FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12682901 ↗
• MalfunctionJun 21, 2021Deformation Due to Compressive Stress; Deformation Due to Compressive Stress

  CUSTOMER REPORTS "BENT GUIDEWIRE". NO PATIENT INJURY REPORTED. THE PATIENT'S CONDITION IS REPORTED AS FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12031359 ↗
• MalfunctionJun 7, 2021Unraveled Material; Unraveled Material

  COMPLAINT FOUND IN MAUDE DATABASE: "THE LEFT SIDE THE GUIDEWIRE STARTED TO UNRAVEL WITH THE TIP STILL IN THE VEIN ITSELF AS I WAS TRYING TO GUIDE IT INTO THE VEIN WHILE CHANGING THE ANGLE OF THE NEEDLE IN CASE I WAS HITTING AGAINST THE WALL OF THE VEIN. I REMOVED THE INTRODUCER NEEDLE SO THAT THE GUIDEWIRE WAS NOT SNAGGED ON THE BEVEL OF THE NEEDLE AND THEN TRIED TO REMOVE THE GUIDEWIRE. AFTER SOME INITIAL RESISTANCE I WAS ABLE TO GET THE GUIDEWIRE OUT OF THE VEIN AND VERIFIED THAT THE TIP HAD BEEN REMOVED. WE KEPT THE FAULTY GUIDEWIRE SO THAT THE INCIDENT COULD BE COMMUNICATED TO THE MANUFACTURER."

  Patient problems: Insufficient Information

  MAUDE report 11948265 ↗
• MalfunctionMay 19, 2021Loose or Intermittent Connection; Unraveled Material

  THE GUIDEWIRE FROM THE INCLUDED AAROW CVC KIT COMPLETELY UNWOUND DURING DEPLOYMENT LEADING TO LOOSE WIRE ATTEMPTING TO ENTER THE PATIENT'S BLOODSTREAM. ER DOCTOR WAS ABLE TO REMOVE AND RETRIEVE THE WIRE BUT THIS COULD HAVE BEEN A CATASTROPHIC EVENT.

  Patient problems: Insufficient Information

  MAUDE report 11852200 ↗

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-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
• 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-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-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-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-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-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

…and 39 more.