ARROW IPN036829Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 20801902117711), received between Sep 8, 2021 and Sep 8, 2021 — classified as 1 malfunction.

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

3 FDA recall records name this device's identifier, 3 still open.

31 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 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 · Recall details · FDA record ↗

2. 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-2391-2026 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗

3. Jul 26, 2024Open, Classified

   Reports have been received regarding open seals on the packaging.

   Z-3299-2024 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 8, 2021Material Puncture/Hole; Material Puncture/Hole

  THE COMPLAINT IS REPORTED AS: A RADIAL ARTERIAL LINE WAS PLACED UNEVENTFULLY IN PRE-OP AND A SMALL HOLE WAS FOUND AT THE POINT WHERE THE CATHETER NARROWED AND ENTERED INTO THE PATIENT'S SKIN. ARTERIAL CATHETER COULD NOT BE WIRED AND A NEW CATHETER THREADED SO THIS ONE WAS REMOVED. RESULTED IN SMALL HEMATOMA AND BRUISING. SEVERAL OTHER ATTEMPTS HAD TO BE MADE AT ARTERIAL VASCULAR ACCESS DUE TO CATHETER BEING UNUSABLE. THE PATIENT'S CONDITION IS REPORTED AS FINE.

  Patient problems: Hematoma

  MAUDE report 12443881 ↗

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-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-1970-2018 · Apr 11, 2018 · Terminated
  Radial Artery Catheterization Kit; Product Codes: ASK-04020-AH, ASK-04020-MIHS, ASK-04120-HF1
• Z-1972-2018 · Apr 11, 2018 · Terminated
  Radial Artery Catheterization Kit with Sharps Safety Features; Product Codes: ASK-04020-RIHM
• Z-1968-2018 · Apr 11, 2018 · Terminated
  Radial Arterial Access Kit; Product Code: ASK-04001-BID2
• Z-1969-2018 · Apr 11, 2018 · Terminated
  Arterial Line Kit with Sharps Safety Features and Maximal Barrier Precautions; Product Code: ASK-04018-OH1
• 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-1285-2018 · Oct 26, 2017 · Terminated
  Radial Artery Catheterization Kit; Model: AK-04122
• Z-1283-2018 · Oct 26, 2017 · Terminated
  Radial Artery Catheterization Kit; Model: AK-04020-C
• 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
• Z-1286-2018 · Oct 26, 2017 · Terminated
  Radial Artery Catheterization Kit; Model: AK-04220
• Z-1281-2018 · Oct 26, 2017 · Terminated
  Radial Artery Catheterization Kit; Model: AK-04018

…and 16 more.