ARROW IPN029791Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10801902144550), received between Jul 10, 2023 and Jul 10, 2023 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 10, 2023Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  CUSTOMER REPORTED PRIOR INCIDENTS OF "MONITORING LINE IS VERY PLIABLE AND IT IS CAUSING FALSE READING". IT WAS REPORTED "THE TUBING IS VERY SOFT (DESCRIBED AS SIMILAR TO OUR IV TUBING) AND THE DIAMETER IS LARGER THAN THE REGULAR PRESSURE TUBING. BOTH FEATURES CAUSED THE WAVEFORM TO BE DAMPENED." NO SPECIFIC PATIENT OR EVENT DETAILS WERE AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 17287515 ↗
• MalfunctionJul 10, 2023Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  CUSTOMER REPORTED "MONITORING LINE IS VERY PLIABLE AND IT IS CAUSING FALSE READING". IT WAS REPORTED "THE TUBING IS VERY SOFT (DESCRIBED AS SIMILAR TO OUR IV TUBING) AND THE DIAMETER IS LARGER THAN THE REGULAR PRESSURE TUBING. BOTH FEATURES CAUSED THE WAVEFORM TO BE DAMPENED." THE RN SWITCHED TO ANOTHER BRAND OF TUBING AND THE WAVEFORM WAS NORMAL. NO PATIENT HARM WAS REPORTED. IT WAS REPORTED THE PATIENT WAS STABLE AFTER ARTERIAL LINE EXTENSION TUBING CHANGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17287199 ↗

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-1968-2018 · Apr 11, 2018 · Terminated
  Radial Arterial Access Kit; Product Code: ASK-04001-BID2
• Z-1970-2018 · Apr 11, 2018 · Terminated
  Radial Artery Catheterization Kit; Product Codes: ASK-04020-AH, ASK-04020-MIHS, ASK-04120-HF1
• 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-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-1282-2018 · Oct 26, 2017 · Terminated
  Radial Artery Catheterization Kit; Model: AK-04020
• Z-1285-2018 · Oct 26, 2017 · Terminated
  Radial Artery Catheterization Kit; Model: AK-04122
• Z-1284-2018 · Oct 26, 2017 · Terminated
  Radial Artery Catheterization Kit; Model: AK-04120
• Z-1283-2018 · Oct 26, 2017 · Terminated
  Radial Artery Catheterization Kit; Model: AK-04020-C
• Z-1286-2018 · Oct 26, 2017 · Terminated
  Radial Artery Catheterization Kit; Model: AK-04220

…and 17 more.