ARROW IPN030863Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10801902000559), received between Feb 22, 2021 and Jul 1, 2024 — classified as 8 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 1, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT "ON 21ST MAY 2024, IN THE RESUSCITATION UNIT, A LEAK WAS OBSERVED ON THE DISTAL LINE OF THE CATHETER, WHERE THE PARENTERAL NUTRITION WAS BEING ADMINISTRATED. FOLLOWING THIS INCIDENT - WHICH WAS OBSERVED STRAIGHT AWAY (FEMALE PATIENT'S PILLOW WAS WET, AFTER COMPLETE CHANGE OF THE PERFUSION LINE, TUBE, RAMP AND ANTI-FLUX VALVE) - THE DEVICE WAS REMOVED AND A PERIPHERIC VENOUS LINE WAS INSERTED ON THE FEMALE PATIENT AGE 30, WITHOUT ANY CLINICAL CONSEQUENCES.".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19643199 ↗
• MalfunctionAug 10, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT: INCIDENT OCCURRED ON (B)(6) 2023. FOLLOWING A PATIENT'S SLIGHT AGITATION, THE CONNECTION OF THE PROXIMAL CATHETER HUB (WHITE TIP) BROKE AND THE LUER LOCK TIP SEPARATED. THE SEPARATED TUBING WAS IMMEDIATELY CLAMPED. AT THE TIME OF THE SEPARATION, THE PROXIMAL LINE WAS NO LONGER USED. PREVIOUS DAYS OF THE INCIDENT, MEDICATION EUPRESSYL AND NIMOTOP WERE INFUSED VIA A SYRINGE PUMP IN THE PROXIMAL LINE. THERE WAS NO CONSEQUENCE FOR THE PATIENT. TO SOLVE THE ISSUE A NEW CV-12853 WAS INSERTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17504457 ↗
• MalfunctionSep 29, 2021Material Puncture/Hole; Material Puncture/Hole

  THE PATIENT NEEDED A CENTRAL CATHETER AND AFTER INSERTION, THE USER OBSERVED THE PRESENCE OF A TINY HOLE IN THE CATHETER BODY. THE CATHETER WAS REMOVED AND REPLACED. THERE WAS NO CONSEQUENCE FOR THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12549042 ↗
• MalfunctionAug 23, 2021Deformation Due to Compressive Stress; Deformation Due to Compressive Stress

  IT WAS REPORTED THE GUIDEWIRE KINKED IN USE. THE CONSEQUENCE WAS A DELAY IN TREATMENT DUE TO TIME TO REMOVE THE DEVICE AND INSERT ANOTHER CATHETER. NO OTHER CLINICAL CONSEQUENCE. NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12356132 ↗
• MalfunctionAug 23, 2021Deformation Due to Compressive Stress; Deformation Due to Compressive Stress

  IT WAS REPORTED THE GUIDEWIRE KINKED IN USE. THE CONSEQUENCE WAS A DELAY IN TREATMENT DUE TO TIME TO REMOVE THE DEVICE AND INSERT ANOTHER CATHETER. NO OTHER CLINICAL CONSEQUENCE. NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12356098 ↗
• MalfunctionMay 19, 2021Migration or Expulsion of Device; Migration or Expulsion of Device

  THE COMPLAINT IS REPORTED AS: "THE MEDIUM LINE OF THE CATHETER SLIPPED FROM ITS ATTACHMENT WHILE THE BANDAGE WAS REMOVED. THE CENTRAL LINE WAS NO LONGER IN THE RIGHT POSITION IN THE JUGULAR VEIN BECAUSE THE CATHETER GRADUALLY MOVED." THE CENTRAL LINE WAS REPLACED. ADDITIONAL INFORMATION WAS REQUESTED ON THE PATIENT'S CONDITION, BUT WAS NOT AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: Insufficient Information

  MAUDE report 11853050 ↗
• MalfunctionApr 26, 2021Migration or Expulsion of Device; Migration or Expulsion of Device

  THE COMPLAINT IS REPORTED AS: "INVOLVED A 76-YEAR-OLD PATIENT HOSPITALIZED FOR TREATMENT OF AN ACUTE CORONARY SYNDROME. THE CATHETER WAS INSERTED ON 27 MARCH 2021 IN THE FEMORAL SITE. THE PATIENT WAS FOUND WITH HIS CVC DETACHED AND ON THE GROUND. THE 2 STITCHES WERE STILL IN PLACE BUT THE JUNCTURE HUB WAS CRACKED." IT WAS REPORTED THE PLASTIC WINGS WERE CRACKED. THE PATIENT DID NOT HAVE CORDARONE INFUSION FOR OVER TWO HOURS, BUT THERE WAS NO PATIENT INJURY OR COMPLICATION. THE CATHETER WAS NOT REPLACED, THE PATIENT RECEIVED TREATMENT THROUGH A PERIPHERAL VEIN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11724206 ↗
• MalfunctionFeb 22, 2021Fluid/Blood Leak; Fluid/Blood Leak

  THE COMPLAINT IS REPORTED AS: "IT WAS OBSERVED THAT THERE WAS A LEAK ON THE EXTENSION LINE. MAYBE CUT BECAUSE OF THE CLAMP." THE CATHETER WAS REMOVED AND REPLACED. IT WAS REPORTED THERE WAS NO CONSEQUENCE FOR THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11362372 ↗

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-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-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-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-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.