ARROW IPN030855 (REF CV-12703)Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 10801902105223), received between Sep 30, 2021 and Oct 21, 2025 — classified as 3 injuries, 11 malfunctions.

The most frequently reported specific device problem is “Material Twisted/Bent” (5 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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 21, 2025Obstruction of Flow; Material Twisted/Bent; Obstruction of Flow; Material Twisted/Bent

  IT WAS REPORTED THAT "AN INCIDENT HAS OCCURRED ON (B)(6) 2025. INVOLVING THE CVC USED FOR THE ADMINISTRATION OF UNFRACTIONATED HEPARIN (UFH) BY ELECTRIC SYRINGE PUMP. THIS TUBING OF THE CVC IS VERY THIN AND EASILY TWISTED, WHICH HAS LED TO SEVERAL BLOCKAGES OF THE ELECTRIC SYRINGE PUMP. THESE BLOCKAGES HAVE CAUSED INTERRUPTIONS IN THE ADMINISTRATION OF UNFRACTIONATED HEPARIN TO THE PATIENT. THE "OCCLUSION" ALARM OF THE ELECTRIC SYRINGE PUMP WAS TRIGGERED ON (B)(6) 2025, AT AROUND 11 A.M. IT WAS NOT POSSIBLE TO DETERMINE HOW LONG THE TUBING HAD BEEN TWISTED. THE PATIENT HAS BEEN ON UNFRACTIONATED HEPARIN SINCE ADMISSION TO THE WARD AS PART OF TREATMENT FOR A LEFT INTRAVENTRICULAR THROMBUS REQUIRING STRONG ANTICOAGULATION." THERE WAS PARTIAL INTERRUPTION OF UNFRACTIONED HEPARIN DUE TO THE OBSTRUCTIONS RELATED TO THE TWISTING OF THE CATHETER. THE USER REPLACED THE CENTRAL LINE, TUBING, AND DRESSING. THERE WAS NO DIRECT CONSEQUENCES RELATED TO THE EVENT. THE PATIENT'S CURRENT CONDITION WAS REPORTED AS "PRECARIOUS BUT THIS IS RELATED TO THE UNDERLYING CONDITION."

  Patient problems: Insufficient Information

  MAUDE report 23347431 ↗
• MalfunctionOct 20, 2025Unraveled Material; Physical Resistance/Sticking; Unraveled Material; Physical Resistance/Sticking

  IT WAS REPORTED THAT " DURING THE INSERTION OF THE CATHETER AT THE MOMENT OF INTRODUCTION INTO THE VEIN, A DEFECT OF THE GUIDE WAS NOTICED, PREVENTING THE GUIDE FROM PASSING THROUGH THE DILATOR. THE TIP OF THE GUIDE WAS IMPROPERLY WOUND. " THE USER CHANGED TO A NEW SET TO RESOLVE THE ISSUE. THE LINE WAS PLACED IN A DIFFERENT LOCATION AND THE PATIENT RECEIVED A HEMATOMA DUE TO REPUNCTURING. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE".

  Patient problems: Hematoma; Needle Stick/Puncture

  MAUDE report 23334757 ↗
• InjuryOct 9, 2025Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT "INCIDENT OCCURRED ON (B)(6) 2025. THE CVC 3-LUMEN PLASTIC TUBING ARE VERY FLEXIBLE AND THIN, WHICH CAN CAUSE TWISTING OR KINKING. (BETWEEN THE PATIENT'S AND THE FIRST HUB CONNECTION). THE PATIENT WAS ON IV CORDARONE WITH AN ELECTRIC SYRINGE PUMP, WHICH LED TO OCCLUSION OF THE ELECTRIC SYRINGE PUMP AND INTERRUPTION OF THE INTRAVENOUS TREATMENT. PATIENT WAS IN ATRIAL FIBRILLATION AT 150BPM." A BOLUS OF IV CORDARONE WAS DELIVERED TO THE PATIENT. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "UNKNOWN".

  Patient problems: Arrhythmia

  MAUDE report 23257726 ↗
• MalfunctionOct 8, 2025Difficult to Insert; Dull, Blunt; Difficult to Insert; Dull, Blunt

  IT WAS REPORTED THAT " IT WAS DIFFICULT TO INSERT THE NEEDLE INTO PATIENT'S SKIN, AS IF IT WAS NOT BEVELLED. INTERVENTION PERFORMED BY A SENIOR DOCTOR." THE DEVICE WAS REPLACED. THERE WAS NO PATIENT CONSEQUENCES BESIDES PAIN. THERE WAS NO MEDICAL INTERVENTION REQUIRED. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE".

  Patient problems: Pain

  MAUDE report 23244548 ↗
• MalfunctionSep 24, 2024Failure to Advance; Physical Resistance/Sticking; Failure to Advance; Physical Resistance/Sticking

  IT WAS REPORTED "THE WIRE CANNOT BE ADVANCED THROUGH THE NEEDLE. BLOOD COULD BE ASPIRATED." THE USER CHANGED TO A NEW SET. THERE WAS NO MEDICAL INTERVENTION REQUIRED. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE".

  Patient problems: Needle Stick/Puncture

  MAUDE report 20290928 ↗
• MalfunctionJun 4, 2024Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED "THE PROXIMAL LINE BENT." THERE WAS NO CLINICAL CONSEQUENCES FOR THE PATIENT. NO MEDICAL INTERVENTION REQUIRED. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19461723 ↗
• MalfunctionMay 9, 2024Material Twisted/Bent; Physical Resistance/Sticking; Material Twisted/Bent; Physical Resistance/Sticking

  IT WAS REPORTED THAT: DURING CENTRAL VENOUS LINE INSERTION, WHEN INTRODUCING THE GUIDEWIRE THROUGH THE INTRODUCER NEEDLE WITH ABOUT 1/3 OF THE LENGTH INSERTED, DOCTOR FOUND IT HARD FOR THE GUIDEWIRE TO FURTHER ADVANCE. THE DOCTOR THEN TRIED TO REMOVE THE GUIDEWIRE VIA THE INTRODUCING NEEDLE, BUT THE GUIDEWIRE WAS STUCK AND COULD NOT BE REMOVED. FINALLY, THE GUIDEWIRE AND THE INTRODUCER NEEDLE WAS REMOVED FROM THE PATIENT TOGETHER. ANOTHER SET WAS OPENED AND SECOND ATTEMPT WAS PERFORMED. THE SECOND ATTEMPT WAS SUCCESSFUL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19275648 ↗
• MalfunctionMay 7, 2024Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED "THE BROKEN GUIDEWIRE WAS FOUND WHILE OPENING THE PACKING OF PRODUCT." ANOTHER SET WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INVOLVEMENT. THEREFORE NO PATIENT HARM OR INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19259064 ↗
• MalfunctionMar 13, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT: ON (B)(6) 2024: AFTER MOVING THE PATIENT, THE NURSE CHECKED THE LINES AND REALIZED THAT THE EXTENSION LUER TIP BROKE OFF AND WAS STUCK IN THE CATHETER CONNECTOR. ON (B)(6) 2024: FOR THE SAME PATIENT, WHEN THE DEVICE USED ON (B)(6) 2024 - THAT FACED THE INCIDENT WAS REPLACED, THE EXTENSION LUER TIP BROKE OFF AGAIN AND BECAME STUCK IN THE CATHETER CONNECTOR. THERE WAS ONLY ONE LINE REMAINED ON THE CATHETER FOLLOWING THE TWO SUCCESSIVE BREAKAGES. ADDITIONAL INFORMATION: THE LINE IS STILL IN THE PATIENT. THERE MAY HAVE BEEN AN ISSUE BETWEEN THE CATHETER AND THE EXTENSION LINE WHICH WAS FROM ANOTHER COMPANY. THEY ARE QUESTIONING THE DIAMETER OF THE LEUR HUB OF THE EXTENSION LINE. THERE DOESN'T SEEM TO BE AN ISSUE WITH THE TELEFLEX CATHETER. THE PATIENT IS REPORTED AS STABLE. ASSOCIATED COMPLAINTS: 3006425876-2024-00225 AND 3006425876-2024-00226.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18892475 ↗
• MalfunctionMar 13, 2024Fluid/Blood Leak; Material Separation; Fluid/Blood Leak; Material Separation

  IT WAS REPORTED THAT: ON (B)(6) 2024: AFTER MOVING THE PATIENT, THE NURSE CHECKED THE LINES AND REALIZED THAT THE EXTENSION LUER TIP BROKE OFF AND WAS STUCK IN THE CATHETER CONNECTOR. ON (B)(6) 2024: FOR THE SAME PATIENT, WHEN THE DEVICE USED ON (B)(6)2024 - THAT FACED THE INCIDENT WAS REPLACED, THE EXTENSION LUER TIP BROKE OFF AGAIN AND BECAME STUCK IN THE CATHETER CONNECTOR. THERE WAS ONLY ONE LINE REMAINED ON THE CATHETER FOLLOWING THE TWO SUCCESSIVE BREAKAGES. ADDITIONAL INFORMATION: THE LINE IS STILL IN THE PATIENT. THERE MAY HAVE BEEN AN ISSUE BETWEEN THE CATHETER AND THE EXTENSION LINE WHICH WAS FROM ANOTHER COMPANY. THEY ARE QUESTIONING THE DIAMETER OF THE LEUR HUB OF THE EXTENSION LINE. THERE DOESN'T SEEM TO BE AN ISSUE WITH THE TELEFLEX CATHETER. THE PATIENT IS REPORTED AS STABLE. ASSOCIATED COMPLAINTS: 3006425876-2024-00225 AND 3006425876-2024-00226.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18892468 ↗
• InjuryJan 31, 2024Difficult to Remove; Material Deformation; Difficult to Remove; Material Deformation

  IT WAS REPORTED THAT "THE NIGHT NURSE CANNOT REMOVE THE CVC DUE TO RESISTANCE. PATIENT INITIALS (B)(6), MALE, 65 YEARS-OLD, 95 KG. THE DOCTOR ON CALL ALSO OBSERVED THE SAME RESISTANCE. THE DAY TEAM REQUESTED THE HELP OF THE VASCULAR SURGEONS WHO REMOVED THE CVC, WITH A SMALL BUBBLE, CVC BALLOONED OBSERVED. CLINICAL CONSEQUENCES: DIFFICULTIES DURING REMOVAL. ADDITIONAL INFORMATION: THE PATIENT PRESENTED WITH HYPERTHERMIA, THERE WAS INFLAMMATION AT THE ACCESS SITE. THE DEVICE WAS SURGICALLY REMOVED.

  Patient problems: Hyperthermia; Inflammation; Pain

  MAUDE report 18612206 ↗
• MalfunctionAug 10, 2023Material Deformation; Material Deformation

  IT WAS REPORTED THAT "GUIDEWIRE IS NOT GOOD. NOT MEETING THE STANDARD". IT WAS REPORTED THE WIRE WAS NOT USED ON THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17498976 ↗
• InjuryOct 19, 2021Improper Flow or Infusion; Improper Flow or Infusion

  THE COMPLAINT IS REPORTED AS: WHEN RINSING ONE OF THE LINES OF THE CVC, A BOLUS OF NOREPINEPHRINE OCCURRED. THE PATIENT HAD A "HEMODYNAMIC DISORDER" WITH HYPERTENSIVE SURGE THEN HYPOTENSIVE. THE NORADRENALINE WAS STOPPED AND THE PATIENT WAS PUT UNDER OXYGEN. IT WAS REPORTED THE SAME ISSUE RECURRED SHORTLY AFTERWARDS WHEN HYDRATION WAS CHANGED ON THE LINE FOR ISOFUNDINE RESULTING IN A BOLUS OF SODIUM. AFTER MEDICAL INTERVENTION AND HEMODYNAMIC STABILIZATION OF THE PATIENT, HYDRATION WAS PUT ON ANOTHER PERIPHERAL LINE. THE NORADRENALINE WAS ON THE MEDIAL LINE AT 8MG/40ML. PATIENT WAS REPORTED TO BE FINE.

  Patient problems: High Blood Pressure/ Hypertension

  MAUDE report 12658179 ↗
• MalfunctionSep 30, 2021Failure to Deliver; Failure to Deliver

  THE COMPLAINT IS REPORTED AS: HAPPENED IN THE ROOM OF THE PATIENT IN RESUSCITATION DEPARTMENT. INVOLVED A HYPOTENSIVE PATIENT REQUIRING THE INSERTION OF A CVC IN LEFT INTERNAL JUGULAR WITH INJECTION OF NORADRENALINE ON THE TRI-LUMEN CVC. THERE WAS A RAPID INCREASE OF THE NORADRENALINE (UP TO 15 MGR/H OR SPEED 30 CC/H, WHICH IS A VERY VERY HIGH DOSE) BUT WITH NO BENEFICIAL EFFECT FOR THE PATIENT. THE TEAM DECIDED TO INSERT A SECOND CENTRAL VENOUS CATHETER IN THE RIGHT FEMORAL. THERE WAS AN INCREASE OF THE PRESSURE ON THIS NEW CVC (THE ONE INSERTED IN FEMORAL) BECAUSE OF THE INJECTION OF NOREPINEPHRINE. THE PATIENT WAS TREATED, BUT THERE WAS A WASTE OF TIME TO INSERT THE SECOND DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12555899 ↗

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-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-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
• 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.