ARROW IPN920646Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10801902196351), received between Jun 27, 2022 and May 24, 2023 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Physical Resistance/Sticking” (2 reports).

17 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

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.

• MalfunctionMay 24, 2023Separation Problem; Separation Problem

  IT WAS REPORTED THAT: " THE SIDE PORT OF THE SLUICE COMES OFF THE SLUICE DURING RELOCATION WITH LITTLE PULL. THE ISSUE WAS FOUND DURING USE ON PATIENT. ADDITIONAL INFORMATION STATES THAT: THERE WAS AN INTERRUPTION TO TREATMENT AS IT WAS NECESSARY TO CHANGE THE AIRLOCK AND PULMONARY ARTERY CATHETER. THE PATIENT EXPERIENCED BLEEDING AND THE CURRENT CONDITION IS UNKNOWN.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 16992865 ↗
• MalfunctionMar 30, 2023Deformation Due to Compressive Stress; Physical Resistance/Sticking; Deformation Due to Compressive Stress; Physical Resistance/Sticking

  IT WAS REPORTED THAT: "THE GUIDE GOT BLOCKED IN THE PUNCTURE NEEDLE. IT WAS IMPOSSIBLE TO REMOVE THE NEEDLE WITHOUT REMOVING THE GUIDE.". THE CONSEQUENCE WAS REPORTED AS "UNNECESSARY PUNCTURE AND FAILURE TO INSERT THE CATHETER. PATIENT HAD A HEMATOMA AT THE PUNCTURE POINT. DEVICE WAS REPLACED.". THE INSERTION SITE WAS THE "INNER RIGHT JUGULAR". NO MEDICAL INTERVENTION WAS REQUIRED TO TREAT THE HEMATOMA. CUSTOMER REPORTED THERE WAS NO CONSEQUENCE FOR THE PATIENT.

  Patient problems: Hematoma

  MAUDE report 16648866 ↗
• MalfunctionJun 27, 2022Unraveled Material; Physical Resistance/Sticking; Unraveled Material; Physical Resistance/Sticking

  IT WAS REPORTED THERE WAS RESISTANCE WHEN REMOVING THE GUIDEWIRE AND DILATOR AND THE GUIDEWIRE UNRAVELLED. THE ENTIRE DEVICE INCLUDING THE GUIDEWIRE WAS REMOVED. THERE WAS NO PATIENT HARM. THE PATIENT'S CONDITION IS REPORTED AS FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14837134 ↗

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-2385-2026 · Apr 21, 2026 · Open, Classified
  Description/REF: ACCESS TRAY/GU-04020; PSI KIT: 8.5 FR/AK-09803-CDC; PSI KIT: 9 FR/AK-09903-CDC; PSI KIT: 8.5 FR X 4 IN (10 CM)/ASK-09810-PCMH1; PSI KIT: 9 FR X 10 CM/ASK-09903-KH;
• 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-2011-2018 · Apr 11, 2018 · Terminated
  Spring-Wire Guide Introducer Catheter Assembly; Product Code: CN-04018
• 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-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

…and 2 more.