ARROW IPN036979Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10801902118087), received between May 17, 2024 and Sep 23, 2024 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Physical Resistance/Sticking” (3 reports).

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

2 other recalls cover devices cleared under the same FDA submission (K810962); 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 ↗

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 23, 2024Material Twisted/Bent; Physical Resistance/Sticking; Material Twisted/Bent; Physical Resistance/Sticking

  IT WAS REPORTED THAT: " THE NEEDLE WENT INTO THE ARTERY JUST FINE. SHE WAS ABLE TO PUT THE GUIDEWIRE THROUGH THE NEEDLE SMOOTHLY. THE WIRE KINKED AT THE TIP OF THE NEEDLE SO SHE COULD NOT MOVE THE WIRE AND NEEDLE. DUE TO THE KINKED WIRE, SHE REMOVED THE NEEDLE AND WIRE TOGETHER AS ONE UNIT OUT THE PATIENT. TREATMENT WAS DELAYED BUT THERE WAS NO OTHER PATIENT HARM. ANOTHER DEVICE WAS USED INSTEAD."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20277206 ↗
• MalfunctionSep 19, 2024Difficult to Remove; Material Twisted/Bent; Physical Resistance/Sticking; Difficult to Remove; Material Twisted/Bent; Physical Resistance/Sticking

  IT WAS REPORTED "PATIENTS RADIAL ATRIAL LINE WAS ACCIDENTALLY REMOVED WHILE ON 3 VASOPRESSORS. ATTEMPTED TO REESTABLISH RADIAL ARTERIAL ACCESS WITH NO SUCCESS. WHEN ATTEMPT WAS MADE TO PLACE FEMORAL ARTERIAL LINE, I WAS ABLE TO EASILY CANNULATE THE ARTERY WITH MY NEEDLE, HAD GREAT PULSATILE BLOOD FLOW, BUT WHEN I ATTEMPT TO THREAD THE GUIDE WIRE, I WAS UNABLE TO ADVANCE AND HAD DIFFICULTY REMOVING THE WIRE. WHEN I WAS FINALLY ABLE TO REMOVE THE WIRE, IT WAS KINKED". THERE WAS 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 20255567 ↗
• MalfunctionMay 21, 2024Unraveled Material; Physical Resistance/Sticking; Unraveled Material; Physical Resistance/Sticking

  IT WAS REPORTED THAT: "THE INTRODUCER NEEDLE GOES INTO THE ARTERY AND THEN THEY PUT THE GUIDEWIRE THROUGH THE NEEDLE. WHEN SHE GOES TO PULL THE WIRE OUT, THE TIP GOT STUCK ON THE NEEDLE. THE WIRE WAS ABLE TO BE REMOVED IN FULL FROM THE PATIENT. IT WAS UNRAVELED." THE PATIENT IS REPORTED AS FINE. ASSOCIATED COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19357885 ↗
• MalfunctionMay 17, 2024Unraveled Material; Unraveled Material

  IT WAS REPORTED THAT: "THE INTRODUCER NEEDLE GOES INTO THE ARTERY AND THEN THE GUIDEWIRE IS PUT THROUGH THE NEEDLE. WHEN THE WIRE IS PULLED OUT THE TIP GETS STUCK ON THE NEEDLE. THE WIRE WAS ABLE TO BE REMOVED FROM THE PATIENT BUT GOT CAUGHT UP WHEN REMOVING." THERE WAS NO REPORTED PATIENT HARM OR CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19339170 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K810962. 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-1960-2018 · Apr 11, 2018 · Terminated
  Spring Wire Guide Introducer Needle; Product Codes: AN-04320 and AN-04418