ARROW IPN037078Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10801902121551), received between May 28, 2021 and Dec 10, 2024 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Deformation Due to Compressive Stress” (1 report).

2 FDA recall records name this device's identifier, 2 still open.

2 other recalls cover devices cleared under the same FDA submission (K021120); 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-2391-2026 · Root cause: Nonconforming Material/Component · 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-2368-2026 · Root cause: Nonconforming Material/Component · 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.

• InjuryDec 10, 2024Material Separation; Material Separation

  IT WAS REPORTED: "AFTER THE REGISTERED NURSE (RN) REMOVED AN ARTERIAL LINE FROM THE RIGHT WRIST, HE NOTED A PIECE OF THE CATHETER TIP WAS BROKEN OFF. FOREIGN BODY VIEWED ON ULTRASOUND. PATIENT WAS TAKEN TO THE SURGICAL OPERATING ROOM, AND THE FOREIGN BODY WAS REMOVED SUCCESSFULLY. THE TIP WAS NOTED TO BE 3.5 CM IN LENGTH AND 0.2 CM IN DIAMETER. THE PATIENT WAS DISCHARGED AND HAD NO HARM OR INJURY".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20893935 ↗
• MalfunctionMay 28, 2021Deformation Due to Compressive Stress; Deformation Due to Compressive Stress

  THE DOCTORS IN CCU WERE PLACING A RADIAL ARTERIAL LINE IN PATIENT. THEY DID NOT HAVE ANY DIFFICULTY ADVANCING THE WIRE BUT WHEN THEY ADVANCED THE CATHETER THEY MET RESISTANCE. THEY REMOVED BOTH THE WIRE AND CATHETER AND FOUND THE WIRE WAS BENT AND A PIECE OF THE WHITE CATHETER TIP WAS BROKEN OFF (CATHETER TIP CAPTURED IN 9680794-2021-00263). THE PATIENT'S CONDITION WAS REPORTED AS FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11903970 ↗
• MalfunctionMay 28, 2021Material Fragmentation; Material Fragmentation

  THE DOCTORS IN CCU WERE PLACING A RADIAL ARTERIAL LINE IN PATIENT. THEY DID NOT HAVE ANY DIFFICULTY ADVANCING THE WIRE BUT WHEN THEY ADVANCED THE CATHETER THEY MET RESISTANCE. THEY REMOVED BOTH THE WIRE AND CATHETER AND FOUND THE WIRE WAS BENT AND A PIECE OF THE WHITE CATHETER TIP WAS BROKEN OFF. AN ULTRASOUND AND "OTHER TESTS" PERFORMED TO DETERMINE IF THE TIP HAD COME OFF WITHIN THE PATIENT AND THE TIP WAS NOT LOCATED IN THE PATIENT. THE PATIENT'S CONDITION WAS REPORTED AS FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11903815 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K021120. One submission often covers many models, so check the product and lot details in each record.

• Z-2377-2026 · Apr 21, 2026 · Open, Classified
  Description/REF: ARTERIAL LINE KIT: SL 20 GA X 5 IN/ASK-04510-MM6 RA CATH KIT: 20 GA X 1-3/4IN/NA-04020-X1ASP ACCESS TRAY/ASK-04001-MS RA CATH KIT: 20 GA X 8 CM/ASK-00820-UM1 VESSE
• Z-1973-2018 · Apr 11, 2018 · Terminated
  Radial Artery Catheterization Kit with Sharps Safety Features; Product Codes: ASK-04120-HF