ARROW IPN030769Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10801902027464), received between Aug 29, 2023 and Oct 28, 2025 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Difficult to Advance” (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.

• MalfunctionOct 28, 2025Difficult to Advance; Material Twisted/Bent; Physical Resistance/Sticking; Difficult to Advance; Material Twisted/Bent; Physical Resistance/Sticking

  IT WAS REPORTED THAT "ON (B)(6) 2025, IN PAEDIATRIC INTENSIVE CARE, DURING THE INSERTION OF A CENTRAL VENOUS CATHETER, THE GUIDE DID NOT ADVANCE PROPERLY AND IT BECAME STUCK. WHEN THE GUIDE WAS REMOVED, IT LOOKED TWISTED AND BENT. THE CATHETER COULD NOT BE INSERTED. THE INCIDENT CAUSED SLIGHT BLEEDING AT THE PUNCTURE SITE. A SECOND CATHETER WAS INSERTED, REQUIRING A SECOND PUNCTURE." THERE WAS NO MEDICAL INTERVENTION REQUIRED. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE".

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Needle Stick/Puncture

  MAUDE report 23401922 ↗
• MalfunctionOct 16, 2024Unraveled Material; Mechanical Jam; Unraveled Material; Mechanical Jam

  IT WAS REPORTED "DURING INSERTION OF THE CVC, THE SWG GOT STUCK." A NEW CVC WAS INSERTED. THERE WAS A HEMATOMA ON THE INSERTION SIGHT. THE DEVICE WAS REMOVED AND REPLACED. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "UNKNOWN".

  Patient problems: Hematoma

  MAUDE report 20460904 ↗
• MalfunctionAug 29, 2023Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THE CVC WAS INSTALLED IN A PEDIATRIC PATIENT AND "ON DAY 4 OF THE INSTALLATION, HE PRESENTED A LEAK IN ONE OF THE LUMENS". "DURING THE HOSPITALISATION, ON (B)(6) 2023, A LARGE LEAK WAS OBSERVED , APPARENTLY AT THE INSERTION SITE OF THE CENTRAL VENOUS CATHETER (CVC) LOCATED IN THE RIGHT SUBCLAVIAN ARTERY INSTALLED ON (B)(6) 2023. THE STATE OF THE 3 LUMENS WAS CHECKED BY INFUSING PHYSIOLOGICAL SALINE, WITH THE PROXIMAL AND DISTAL LUMEN REFLUXING AND INFUSING WITHOUT DIFFICULTY , WHILE THE MEDIAL LUMEN SHOWED AN ABUNDANT OUTFLOW OF SALINE. SEDATION IS ADMINISTERED TO THE PATIENT FOR PUNCTURE AND INSTALLATION OF A 13-CM, 3-LUMEN 4 FR CENTRAL VENOUS CATHETER (CVC), WHICH IS FIXED WITH FIXATION POINTS AT THE INSERTION SITE, ONE IN BOTH ORIFICES OF THE CVC FIXATION SYSTEM, AT 10 CMS. THE 3 LUMENS REFLUX AND INFUSE WITHOUT DIFFICULTY."

  Patient problems: Insufficient Information

  MAUDE report 17646105 ↗

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-1119-2019 · Jan 10, 2019 · Terminated
  Arrow Two-Lumen Central Venous Catheterization Set with Blue FlexTip Catheter Product Code: CD-10802 GTN: 00801902015396
• 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-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-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-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-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-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-0650-2018 · Oct 17, 2017 · Terminated
  Multi Lumen Central Venous Catheterization Kit; Product Code: ASK-12703-HH2; Exp. Dates Feb 2018 - Nov 2018

…and 9 more.