ARROW IPN918648Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10801902182187), received between Sep 15, 2022 and Mar 20, 2023 — classified as 3 malfunctions.

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

• MalfunctionMar 20, 2023Deformation Due to Compressive Stress; Physical Resistance/Sticking; Deformation Due to Compressive Stress; Physical Resistance/Sticking

  IT WAS REPORTED THAT "THE DILATOR IMMEDIATELY EXPANDS, TWISTS AND DOES NOT EVEN PASS THROUGH THE SKIN, AND IF IT PASSES THROUGH THE SKIN, IT EXPANDS DURING TISSUE DILATION, GETS STUCK WHEN PULLING OUT, DAMAGES THE TISSUES. THE GUIDEWIRE ALSO BENDS, IT HAPPENED IN PRACTICE THAT THE DILATOR FOLDED THE GUIDEWIRE AND STUCK". IT WAS REPORTED THE "DILATOR END SEPARATED WHEN ALREADY ENTERED THE SKIN AND GOT STUCK TOGETHER WITH THE GUIDEWIRE". THE INSERTION SITE WAS THE SUBCLAVIAN VEIN. THERE WAS "NO SEVERE DAMAGE TO THE PATIENT'S HEALTH". IT WAS REPORTED "NO SEVERE TISSUE DAMAGING, DOCTOR INDICATED SITE BLEEDING, BUT ANOTHER SET WAS USED TO PERFORM THE PROCEDURE". THE PATIENT'S CONDITION IS REPORTED AS FINE.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 16572018 ↗
• MalfunctionMar 20, 2023Material Deformation; Material Deformation

  IT WAS REPORTED THAT "THE DILATOR IMMEDIATELY EXPANDS, TWISTS AND DOES NOT EVEN PASS THROUGH THE SKIN, AND IF IT PASSES THROUGH THE SKIN, IT EXPANDS DURING TISSUE DILATION, GETS STUCK WHEN PULLING OUT, DAMAGES THE TISSUES. THE GUIDEWIRE ALSO BENDS, IT HAPPENED IN PRACTICE THAT THE DILATOR FOLDED THE GUIDEWIRE AND STUCK". IT WAS REPORTED THE "DILATOR END SEPARATED WHEN ALREADY ENTERED THE SKIN AND GOT STUCK TOGETHER WITH THE GUIDEWIRE". THE INSERTION SITE WAS THE SUBCLAVIAN VEIN. THERE WAS "NO SEVERE DAMAGE TO THE PATIENT'S HEALTH". IT WAS REPORTED "NO SEVERE TISSUE DAMAGING, DOCTOR INDICATED SITE BLEEDING, BUT ANOTHER SET WAS USED TO PERFORM THE PROCEDURE". THE PATIENT'S CONDITION IS REPORTED AS FINE.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 16571906 ↗
• MalfunctionSep 15, 2022Deformation Due to Compressive Stress; Difficult to Advance; Deformation Due to Compressive Stress; Difficult to Advance

  IT WAS REPORTED THAT "DURING THE SELDINGER MANEUVER THE SWG STUCK". ADDITIONAL INFORMATION WAS RECEIVED THAT "THE SWG GOT STUCK WHEN THE GUIDE WAS TO SLIDE INTO THE SYRINGE. THE GUIDE WAS BLOCKED BECAUSE THE TAIL OF THE METAL GUIDE WAS MELTED INTO THE PLASTIC IN WHICH THE GUIDE IS WRAPPED". THE DEVICE WAS BEING INSERTED IN THE RIGHT JUGULAR VEIN. THE ANESTHETIST INSERTED THE HIGH-FLOW CVC BEFORE THE SURGICAL INCISION. THE DEVICE WAS REPLACED. THE PATIENT'S CONDITION IS REPORTED AS FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15426827 ↗

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-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-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-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
• 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
• 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.