ARROW IPN000137Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00801902001856), received between Mar 28, 2024 and Sep 11, 2025 — classified as 1 injury, 8 malfunctions.

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

24 other recalls cover devices cleared under the same FDA submission (K862056); 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.

Most reported problems

Recent adverse event reports

The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 11, 2025Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT "THE CATHETER COULD BE ADVANCED THROUGH THE SHEATH, BUT COULD ONLY BE WITHDRAWN WITH GREAT DIFFICULTY." THERE WAS NO PATIENT COMPLICATIONS. NO MEDICAL INTERVENTION REQUIRED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "UNKNOWN".

  Patient problems: Insufficient Information

  MAUDE report 23025949 ↗
• InjuryApr 9, 2025Unraveled Material; Premature Separation; Unraveled Material; Premature Separation

  IT WAS REPORTED THAT "DURING REMOVAL OF A ARROWFLEX SHEATH FROM PATIENT THE SHEATH/COIL WIRE SUDDENLY UNRAVELED. THE SUDDENLY UNRAVELED COIL WIRE WAS SHARP AND TOUCHED THE FINGER OF THE USER (COMPLETING THE REMOVAL OF THE SHEATH). THE SHARP COIL WIRE CUT ONE FINGER OF THE USER TO THE BONE, SO A SURGERY WAS REQUIRED IN ORDER TO TREAT THE INJURY." ADDITIONAL INFORMATION HAS BEEN REQUESTED FROM THE CUSTOMER; HOWEVER, FURTHER DETAILS HAVE NOT BEEN PROVIDED AT THIS TIME. ASSOCIATED MDR NUMBERS INCLUDE:9680794-2025-00291 AND 9680794-2025-00290.

  Patient problems: Laceration(s)

  MAUDE report 21807253 ↗
• MalfunctionApr 9, 2025Unraveled Material; Premature Separation; Unraveled Material; Premature Separation

  IT WAS REPORTED THAT "DURING REMOVAL OF A ARROWFLEX SHEATH FROM PATIENT THE SHEATH/COIL WIRE SUDDENLY UNRAVELED. THE SUDDENLY UNRAVELED COIL WIRE WAS SHARP AND TOUCHED THE FINGER OF THE USER (COMPLETING THE REMOVAL OF THE SHEATH). THE SHARP COIL WIRE CUT ONE FINGER OF THE USER TO THE BONE, SO A SURGERY WAS REQUIRED IN ORDER TO TREAT THE INJURY." ADDITIONAL INFORMATION HAS BEEN REQUESTED FROM THE CUSTOMER; HOWEVER, FURTHER DETAILS HAVE NOT BEEN PROVIDED AT THIS TIME. ASSOCIATED MDR NUMBERS INCLUDE: 9680794-2025-00291.

  Patient problems: Laceration(s)

  MAUDE report 21807146 ↗
• MalfunctionMar 12, 2025Material Separation; Material Separation

  IT WAS REPORTED "DURING REMOVAL OF SHEATH, THE SHEATH BECAME DIFFICULT TO REMOVAL, SHEATH BECOME DISCONNECTED AT HUB AND UN-RIBBON". THE PATIENT HAD NO HARM OR INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21584430 ↗
• MalfunctionFeb 20, 2025Mechanical Jam; Mechanical Jam

  IT WAS REPORTED THAT THE USER ATTEMPTED TO INSERT A PLUG (AMPLATZER VASCULAR PLUG, ABBOTT JAPAN LLC) INTO THE SHEATH BUT COULD NOT. THEREFORE, THE SHEATH WAS REMOVED AND REPLACED WITH ANOTHER DEVICE (DESTINATION , 6FR GUIDING SHEATH, TERUMO CORPORATION) TO COMPLETE THE PROCEDURE. NO INJURY TO THE PATIENT OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21421602 ↗
• MalfunctionJun 17, 2024Difficult to Advance; Physical Resistance/Sticking; Difficult to Advance; Physical Resistance/Sticking

  IT WAS REPORTED " CATHETER DID NOT FIT TROUGH THE SHEATH. CATHETER GOT STUCK, TIPS LOOKS PUSHED TOGETHER. PROCEEDING PROCEDURE WAS HARDER, SINCE THEY COULD NOT USE 6FR MATERIAL". THE DEVICE WAS REMOVED AND REPLACED. 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 19553776 ↗
• MalfunctionMay 14, 2024Obstruction of Flow; Physical Resistance/Sticking; Obstruction of Flow; Physical Resistance/Sticking

  IT WAS REPORTED ""BALLOON STUCK IN CATHETER. HAD TO USE A NEW ONE." NO PATIENT HARM OR INJURY. THERE WAS NO DELAY TO THERAPY. NO MEDICAL INTERVENTION REQUIRED. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19309350 ↗
• MalfunctionMar 29, 2024No Flow; No Flow

  IT WAS REPORTED "WHEN INJECTING THE CONTRAST AGENT, IT CLOGGED AT THE SHEATH SIDEARM AND DID NOT FLOW.THEREFORE, THE SHEATH WAS REMOVED AND REPLACED WITH A NEW ONE TO COMPLETE THE PROCEDURE. 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 19006429 ↗
• MalfunctionMar 28, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED "THE VALVE OF CATHETER LEAKED. THE STAFF TELLS ME THAT THEY HAVE HAD THE SAME PROBLEM WITH THE OTHER MODELS.". ADDITIONAL INFORMATION REPORTED "FAULTY VALVE IN THE SHEATH WHEN INJECTING THROUGH SIDEARM, CONTRAST WAS LEAKED WITH HIGH VELOCITY TOWARD OPERATOR AND STAFF." NO MEDICAL INTERVENTION REQUIRED. NO PATIENT HARM OR INJURY. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE". ASSOCIATED MDR NUMBERS INCLUDE 9680794-2024-00280, 9680794-2024-00279.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18997109 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K862056. 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-1118-2019 · Jan 10, 2019 · Terminated
  Arrow Two-Lumen Central Venous Catheterization Kit with Blue FlexTip Catheter Product Code: AH-11802 (OUS) GTN: 00801902026132
• Z-1119-2019 · Jan 10, 2019 · Terminated
  Arrow Two-Lumen Central Venous Catheterization Set with Blue FlexTip Catheter Product Code: CD-10802 GTN: 00801902015396
• Z-0723-2019 · Nov 14, 2018 · Terminated
  Arrow CVC 2 Lumen, Pediatric Two-Lumen Central Venous Cauterization Set with Blue FlexTip Catheter, 4 Fr 2 Lumen 5cm, Reference # CS-12402 The Arrow CVC is intended to provide sho
• Z-2819-2018 · Jul 10, 2018 · Terminated
  HANDS-OFF Multi-Lumen Central Venous Catheter with Blue FlexTip for use only with Arrow One-Piece Percutaneous Sheath Introducer System, Material HO-14703 The central venous cath
• Z-2818-2018 · Jul 10, 2018 · Terminated
  HANDS-OFF Multi-Lumen Central Venous Catheter with Blue FlexTip for use only with Arrow One-Piece Percutaneous Sheath Introducer System, Material HO-14702 The central venous cathe
• Z-2336-2018 · May 11, 2018 · Terminated
  Multi-Lumen Central Venous Catheterization Set with Blue FlexTip Catheter, CS-15853-E Product CVCs are intended to permit venous access to the central circulation through a single
• Z-1982-2018 · Apr 11, 2018 · Terminated
  ARROWg+ard Blue(R) MAC(TM) Two-Lumen Central Venous Access Kit for use with 7-7.5 Fr. Catheters; Product Code: ASK-21142-WHC2
• Z-1967-2018 · Apr 11, 2018 · Terminated
  Maximal Barrier Drape; Product Code: ASK-04000-HMC
• Z-1978-2018 · Apr 11, 2018 · Terminated
  Two-Lumen Central Venous Catheterization Kit with Blue FlexTip(R) Catheter and Sharps Safety Features; Product Code: ASK-15402-HOP
• Z-1332-2018 · Dec 22, 2017 · Terminated
  (1) Access Tray, Part Number (PN): ASK-04001-MS; Arrow Multi-Lumen CVC Kit (2) PN: CDC-12703-1A; (3) PN: CDC-15703-1A; (4) PN: CDC-15703-B1A; Arrow Two-Lumen CVC Kit (5) PN: CDC-12
• Z-0648-2018 · Oct 17, 2017 · Terminated
  Multi Lumen Central Venous Catheterization Kit with Blue FlexTip Catheter and Sharps Safety Features; Product Code: ASK 15703 NYP; Exp. Dates Feb 2018 - Nov 2018
• Z-0657-2018 · Oct 17, 2017 · Terminated
  Central Venous Catheterization Kit with Blue FlexTip Catheter; Product code: AK-04301; Exp. Dates Feb 2018 - Nov 2018
• Z-0650-2018 · Oct 17, 2017 · Terminated
  Multi Lumen Central Venous Catheterization Kit; Product Code: ASK-12703-HH2; Exp. Dates Feb 2018 - Nov 2018
• Z-0652-2018 · Oct 17, 2017 · Terminated
  Multi Lumen Central Venous Catheterization Kit with Blue FlexTip Catheter, Sharps Safety Features, and Maximal Barrier Precautions Features; Product Code: ASK-12703-WMC1; Exp. Dat

…and 9 more.