ARROW IPN036514Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 30801902117367), received between Jan 24, 2022 and Apr 16, 2026 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Material Twisted/Bent” (2 reports).

1 FDA recall record name this device's identifier, 1 still open.

32 other recalls cover devices cleared under the same FDA submission (K810675); 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-2368-2026 · Root cause: Nonconforming Material/Component · FDA record ↗

Most reported problems

Recent adverse event reports

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

• MalfunctionApr 16, 2026Material Twisted/Bent

  IT WAS REPORTED "ON INSERTION WIRE KINKED SO SECOND KIT OPENED AND THE WIRE KINKED AS WELL UNABLE TO PLACE LINE". THERE WAS NO MEDICAL INTERVENTION REQUIRED. THE PATIENT'S CURRENT CONDITION IS UNKNOWN AT THIS TIME. ASSOCIATE MDR NUMBERS INCLUDE: 9680794-2026-00305.

  Patient problems: Insufficient Information

  MAUDE report 24895610 ↗
• MalfunctionApr 14, 2024Unraveled Material; Unraveled Material

  IT WAS REPORTED "PRIOR TO INSERTING THE GUIDEWIRE, PHYSICIAN NOTICED J-WIRE WAS UNRAVELED IN MIDDLE OF J-BEND. PHYSICIAN DIDN'T ATTEMPT TO INSERT, YET DUE TO TRAUMA, THEY USED THE STRAIGHT END KNOWING IT WASN'T THE "BEST" THING. THEY HAD NO ISSUE IN INSERTION. NO PATIENT HARM OR INJURY. NO MEDICAL INTERVENTION REQUIRED. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19103109 ↗
• MalfunctionApr 14, 2024Material Twisted/Bent; Physical Resistance/Sticking; Material Twisted/Bent; Physical Resistance/Sticking

  IT WAS REPORTED "MET RESISTANCE WHILE INSERTING THE GUIDEWIRE. TRIED TO STRAIGHTEN DISTAL END OF GUIDEWIRE BY HOLDING WIRE INTACT AND PULLING. DID NOT PULL WIRE BACK . PHYSICIAN ROTATED NEEDLE IN CASE BEVEL WAS NEXT TO WIRE WITHOUT ANY IMPROVEMENT. REMOVED ENTIRE WIRE W/NEEDLE. LOOKING AT WIRE WHEN IT WAS REMOVED, PHYSICIAN THOUGHT THE WIRE WAS WEAKENED AT DISTAL TIP ABOVE JTIP". NO PATIENT HARM OR INJURY. NO MEDICAL INTERVENTION REQUIRED. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19103103 ↗
• MalfunctionApr 9, 2024Break; Break

  IT WAS REPORTED THAT: "WHILE THE GUIDEWIRE WAS BEING THREADED THROUGH THE NEEDLE IT BROKE. THIS RESULTED IN ABORTING THE PROCEDURE DUE TO THE WIRE FAILURE." ADDITIONAL INFORMATION HAS BEEN REQUESTED; HOWEVER, IT HAS NOT BEEN RECEIVED AT THE TIME OF THIS REPORT.

  Patient problems: Insufficient Information

  MAUDE report 19069325 ↗
• MalfunctionJan 24, 2022Unraveled Material; Physical Resistance/Sticking; Unraveled Material; Physical Resistance/Sticking

  CUSTOMER REPORTED TIGHTNESS INSERTING SPRING WIRE GUIDE THROUGH INTRODUCER NEEDLE. THE INSERTING CLINICIAN REMOVED THE WIRE AND NOTICED IT HAD APPEARED TO HAVE UNCOILED. NO PATIENT HARM REPORTED. THE PATIENT'S CONDITION IS REPORTED AS FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13337963 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K810675. One submission often covers many models, so check the product and lot details in each record.

• Z-2397-2026 · Apr 21, 2026 · Open, Classified
  Description/REF: RA CATH KIT: 20 GA X 1-1/2IN/NA-04220-1A; RA CATH KIT: 20 GA X 1-1/2IN/NA-04220-X1A; ARTERIAL CATHETER KIT: 18 GA X 16 CM/ASK-04018-HCA; ARTERIAL CATHETER KIT: 18
• Z-3299-2024 · Jul 26, 2024 · Open, Classified
  Arrow Arterial Kits and Trays as follows: (1) Arrow Arterial Access Tray with 0.025" Spring-Wire Guide (Catheter Not Included), REF ASK-04001-BW1; (2) Arrow Arterial Access Tray
• Z-0844-2020 · Dec 12, 2019 · Open, Classified
  Arrow Arterial Catherization Kit-20 Ga. x 4.45 cm Radiopaque Polyurethane over 22 Ga. TW Introducer Needle with Integral .018" (0.46 mm) dia. Spring-Wire Guide Product Code: ASK-04
• Z-2019-2018 · Apr 11, 2018 · Terminated
  Arterial Catheterization Kit; Product Code:NA-04550-1A
• Z-1971-2018 · Apr 11, 2018 · Terminated
  Arterial Catheterization Kit; Product Codes: ASK-04020-DH
• Z-1969-2018 · Apr 11, 2018 · Terminated
  Arterial Line Kit with Sharps Safety Features and Maximal Barrier Precautions; Product Code: ASK-04018-OH1
• Z-1972-2018 · Apr 11, 2018 · Terminated
  Radial Artery Catheterization Kit with Sharps Safety Features; Product Codes: ASK-04020-RIHM
• Z-1970-2018 · Apr 11, 2018 · Terminated
  Radial Artery Catheterization Kit; Product Codes: ASK-04020-AH, ASK-04020-MIHS, ASK-04120-HF1
• Z-1968-2018 · Apr 11, 2018 · Terminated
  Radial Arterial Access Kit; Product Code: ASK-04001-BID2
• Z-1330-2018 · Dec 22, 2017 · Terminated
  (1) Arterial Catheterization Kit, Part Number (PN): ASK-04018-CC; (2) Arterial Line Kit with Sharps Safety Features, PN: ASK-04510-HUM; (3) Arterial Line Kit with Sharps Safety Fea
• Z-1283-2018 · Oct 26, 2017 · Terminated
  Radial Artery Catheterization Kit; Model: AK-04020-C
• Z-1281-2018 · Oct 26, 2017 · Terminated
  Radial Artery Catheterization Kit; Model: AK-04018
• Z-1286-2018 · Oct 26, 2017 · Terminated
  Radial Artery Catheterization Kit; Model: AK-04220
• Z-1282-2018 · Oct 26, 2017 · Terminated
  Radial Artery Catheterization Kit; Model: AK-04020
• Z-1284-2018 · Oct 26, 2017 · Terminated
  Radial Artery Catheterization Kit; Model: AK-04120

…and 17 more.