ARROW IPN036351Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10801902117417), received between Jun 25, 2019 and Jun 5, 2023 — classified as 1 injury, 1 malfunction.

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

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

16 other recalls cover devices cleared under the same FDA submission (K780532); 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-2385-2026 · 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.

• MalfunctionJun 5, 2023Deformation Due to Compressive Stress; Deformation Due to Compressive Stress

  IT WAS REPORTED "WIRE KINKED IN PATIENT". "PATIENT WAS SHOT 4 TIMES IN CHEST AND HAD 3 PERIPHERALS AND LOST ALL 3 LINES. WHEN THEY GOT INTO THE TRAUMA ROOM DIDN'T KNOW HOW TO PUT PATIENT TO SLEEP. DR TRIED TO PUT FEMORAL IN, USED ULTRASOUND, PUT IN A KNICK." THE GUIDEWIRE KINKED WHEN ADVANCING IT INTO THE PATIENT. NO PATIENT HARM WAS REPORTED. THE PATIENT'S CONDITION IS REPORTED AS FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17061371 ↗
• InjuryJun 25, 2019Difficult to Remove; Unraveled Material; Physical Resistance/Sticking

  ANESTHESIOLOGIST USED STEEPER ANGLE AND GOT GOOD BLOOD FLOW IN THE IJ. WIRE THREADED EASILY. ULTRASOUND SHOWING WIRE IN IJ. THEN CRNA THREADED THE CORDIS OVER THE WIRE WITH SLIGHT RESISTANCE. UPON TRYING TO REMOVE THE WIRE FROM THE INTRODUCER, THE WIRE WAS UNRAVELING. THERE WAS LITTLE RESISTANCE BUT IT KEPT UNRAVELING AS IT WAS PULLED OUT. SINCE THE WIRE UNRAVELED THERE WAS CONCERN THAT A PART OF THE WIRE COULD STILL BE INTRAVASCULAR. ULTRASOUND WAS USED TO LOOK AT THE VESSEL. NO DISTRICT SIGNS OF THE WIRE BUT THERE WAS SOMETHING FLAPPING IN THE VESSEL WHICH MAY BE A VASCULAR INJURY. NO HEMATOMA IN THE NECK AND VESSEL LOOKS OVERALL INTACT. DISCUSSED CASE WITH CV SURGEON AND IR. DECISION MADE TO DO A CT OF THE CHEST AND NECK, INTRODUCER WAS SUTURED IN PLACE, CT REVEALED RETAINED GUIDEWIRE AND DECISION MADE FOR IR PROCEDURE TO REMOVE WIRE. FDA SAFETY REPORT ID# (B)(4).

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 8735248 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K780532. One submission often covers many models, so check the product and lot details in each record.

• Z-1242-2020 · Dec 20, 2019 · Terminated
  Arrow PSI Kit for use with 7 - 7.5 Fr. Catheters ASK-09801-UPM
• Z-2576-2018 · May 23, 2018 · Terminated
  Percutaneous Sheath Introducer Kit for use with 7 - 7.5 Fr. Catheters (8 Fr. 10 cm sheath length .035 inch dia. spring-wire guide), REF ES-09807. The percutaneous sheath introduc
• Z-2032-2018 · Apr 11, 2018 · Terminated
  9 Fr. Radiopaque Polyurethane Sheath/Dilator with Integral Hemostasis Valve/Side Port for use with 7 - 8 Fr. Catheters and Arrow Percutaneous Introducer System; Product codes: SS-0
• Z-1976-2018 · Apr 11, 2018 · Terminated
  Percutaneous Sheath Introducer Kit with Integral Hemostasis Valve/Side Port for use with 7.5 - 8 Fr. Catheters; Product Code: ASK-09903-UPA
• Z-2031-2018 · Apr 11, 2018 · Terminated
  ARROWg+ard Blue PSI Kit with Integral Hemostasis Valve/ Side Port for use with 7 - 7.5 Fr. Catheters; Product codes: SF-29803-1
• Z-2011-2018 · Apr 11, 2018 · Terminated
  Spring-Wire Guide Introducer Catheter Assembly; Product Code: CN-04018
• Z-1977-2018 · Apr 11, 2018 · Terminated
  Percutaneous Sheath Introducer Kit with Integral Hemostasis Valve/Side Port and Sharps Safety Features (Recommended for use with 7 Fr. Catheters); Product Code: ASK-09907-SB
• Z-1329-2018 · Dec 22, 2017 · Terminated
  (1) Percutaneous Sheath Introducer Kit with Integral Hemostasis Valve/Side Port, Sharps Safety Features, and Maximal Barrier Precautions for use with 7.5 - 8 Fr. Catheters, Part Nu
• Z-1158-2018 · Nov 14, 2017 · Terminated
  Percutaneous Sheath Introducer Kit with Integral Hemostasis Valve/Side Port, Sharps Safety Features and Maximal Barrier Precautions for use with 7.5 - 8 Fr. Catheters. Permits ven
• Z-1287-2018 · Oct 26, 2017 · Terminated
  Arterial Access Tray, introducer catheter; Model: GU-04020
• Z-2329-2017 · May 9, 2017 · Terminated
  1) Introducer Kit with Integral Hemostasis Valve/Side Port, Sharps Safety Features, and Maximal Barrier Precautions for use with 7.5 - 8 Fr., Introducer Catheter 2) Arrow PSI Kit
• Z-0066-2015 · Aug 6, 2014 · Terminated
  Arrow Select Kits (ASK) and Maximal Barrier Precautions Kits (CDC) with BD Medical Posiflush 10mL Saline Flush Syringe.
• Z-1713-2014 · Apr 14, 2014 · Terminated
  Arrow Percutaneous Sheath Introducer Kits The Percutaneous sheath introducer products permit venous or arterial access and device introduction to the central circulation.
• Z-0468-2014 · Oct 9, 2013 · Terminated
  Arrow Transradial Artery Access products Arrow Transradial Artery Access products are used for percutaneous introduction of devices into the radial artery for diagnostic and thera
• Z-2048-2011 · Mar 25, 2011 · Terminated
  Percutaneous Sheath Introducer Kit Intended usage: Permits venous access and catheter introduction to the central circulation system

…and 1 more.