ARROW IPN918757Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10801902183634), received between Nov 14, 2025 and Feb 16, 2026 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Complete Blockage” (1 report).

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. 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.

• MalfunctionFeb 16, 2026Fluid/Blood Leak; Material Puncture/Hole

  IT WAS REPORTED THAT " ON (B)(6) 2026, AFTER INSERTION OF THE CENTRAL VENOUS LINE, WE NOTICED THAT THE DRESSING WAS VERY WET. (DATE OF CVC INSERTION: (B)(6) 2026; DATE OF CVC REMOVAL: (B)(6) 2026). WHEN CHANGING THE DRESSING, WE SAW THAT THE WHITE LINE HAD A HOLE IN IT." 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 24343847 ↗
• InjuryNov 19, 2025Material Separation; Unraveled Material; Material Separation; Unraveled Material

  IT WAS REPORTED THAT "DURING THE INSERTION OF A CENTRAL VENOUS CATHETER IN THE RIGHT INTERNAL JUGULAR VEIN, A PROBLEM OCCURRED WITH THE GUIDEWIRE. DUE TO INABILITY TO PROPERLY INTRODUCE THE GUIDEWIRE INTO THE VEIN, AN ATTEMPT WAS MADE TO RETRACT THE GUIDEWIRE THROUGH THE INTRODUCER NEEDLE. DURING RETRACTION, THE DISTAL PART OF THE GUIDEWIRE BECAME STUCK INSIDE THE PATIENT. IN AN ATTEMPT TO EXTRACT THE GUIDEWIRE COMPLETELY, CAREFUL MANIPULATION OF THE GUIDEWIRE AND INTRODUCER NEEDLE WAS PERFORMED AFTER CONSULTING A SUPERVISOR (USING MINIMAL FORCE). AS THE NEEDLE AND GUIDEWIRE WERE EXTRACTED, THE EXTERNAL "MANTLE" OF THE GUIDEWIRE WAS SUDDENLY STRIPPED FROM THE INTERNAL WIRE AND SNAPPED COMPLETELY, LEAVING THE DISTAL PART INSIDE THE PATIENT. " THE DEVICE WAS REMOVED SURGICALLY THROUGH A MINIMALLY INVASIVE PROCEDURE AND REPLACED. ALL COMPONENTS WERE REMOVED FROM THE PATIENT. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "CRITICAL, BUT NOT DUE TO THE PROCEDURE".

  Patient problems: Foreign Body In Patient

  MAUDE report 23597334 ↗
• MalfunctionNov 14, 2025Complete Blockage; Complete Blockage

  IT WAS REPORTED "ALARM RANG ON SYRINGE PUMPS ADMINISTERING PATIENT SEDATIVES. WE OBSERVED THE MEDIAL LINE SEEMED BLOCKED, WHICH LED TO A DEFORMATION OF THE CATHETER TUBING." THERE WAS A DELAY TO THERAPY. A NEW DEVICE WAS USED. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23555147 ↗

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-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-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-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-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-1967-2018 · Apr 11, 2018 · Terminated
  Maximal Barrier Drape; Product Code: ASK-04000-HMC
• 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-0654-2018 · Oct 17, 2017 · Terminated
  Arrow Multi Lumen CVC Kit (Central venous catheter); Product Code: CDC-15703-1A; 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-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

…and 9 more.