ARROW IPN036272Recalls & reported problems

Summary

The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 10801902112054), received between Jul 6, 2023 and Feb 13, 2024 — classified as 2 injuries, 19 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (16 reports).

10 other recalls cover devices cleared under the same FDA submission (K011761); 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 21 most recent of 21 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 13, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT: L IJ SITE IS LEAKING. BOTH LUMENS OF THE INTRODUCER ARE OCCLUDED AND 1 LUMEN OF THE CLIP-IN IS OCCLUDED. THE PHYSICIAN WAS ABLE TO FLUSH THE BROWN LUMEN AND CLEAR FLUID LEAKED OUT OF THE SKIN-CATHETER SITE. THE REPORTED DEFECT WAS DETECTED DURING USE ON PATIENT. THE PATIENT CONDITION WAS REPORTED AS "UNKNOWN". SHOULD FURTHER DETAILS BE PROVIDED, THE COMPLAINT WILL BE UPDATED ACCORDINGLY.

  Patient problems: Insufficient Information

  MAUDE report 18693395 ↗
• MalfunctionFeb 1, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED "ALBUMIN INFUSING INTO BROWN LUMEN OF INTRODUCER, ALBUMIN NOTED TO BE LEAKING PROFUSELY FROM SKIN CATHETER JUNCTION." THE PATIENT CONDITION IS REPORTED AS "UNKNOWN" AT THE TIME OF THIS REPORT. IF FURTHER INFORMATION IS RECEIVED, THE COMPLAINT FILE WILL BE UPDATED.

  Patient problems: Insufficient Information

  MAUDE report 18627272 ↗
• MalfunctionJan 22, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED "MAC CATHETER EXTRAVASATION. THE PATIENT FELT BURNING FROM POTASSIUM." THE CATHETER WAS REMOVED AND A NEW CATHETER WAS PLACED. THE PLACEMENT WAS SUCCESSFUL. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE".

  Patient problems: Burning Sensation

  MAUDE report 18558387 ↗
• MalfunctionDec 26, 2023Fluid/Blood Leak; Fluid/Blood Leak

  THE REPORT STATES, "ONE INTRODUCER LEAKED AND NEEDED TO BE REMOVED. FOR THE OTHER INTRODUCER, PROPOFOL, WHICH WAS INFUSING IN THE WHITE LUMEN OF THE INTRODUCER, WAS NOTED TO BE LEAKING FROM THE SKIN-CATHETER JUNCTION". AS A RESULT, THE DEVICE WAS REMOVED FROM THE PATIENT. THERE WAS NO PATIENT HARM OR INJURY. THE PATIENT STATUS IS REPORTED AS "FINE". SEE ASSOCIATED MDR #9680794-2023-01019.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18393836 ↗
• MalfunctionDec 26, 2023Fluid/Blood Leak; Fluid/Blood Leak

  THE REPORT STATES, "ONE INTRODUCER LEAKED AND NEEDED TO BE REMOVED. FOR THE OTHER INTRODUCER, PROPOFOL, WHICH WAS INFUSING IN THE WHITE LUMEN OF THE INTRODUCER, WAS NOTED TO BE LEAKING FROM THE SKIN-CATHETER JUNCTION". AS A RESULT, THE DEVICE WAS REMOVED FROM THE PATIENT. THERE WAS NO PATIENT HARM OR INJURY. THE PATIENT STATUS IS REPORTED AS "FINE". SEE ASSOCIATED MDR #9680794-2023-01020.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18393771 ↗
• MalfunctionOct 11, 2023Air/Gas in Device; Air/Gas in Device

  MEDWATCH FORM RECEIVED REPORTS: "LIJ INTRODUCER WITH CLIP IN TRIPLE CVC PLACED VIA US GUIDED WITH TEE AND REMOVED NEXT DAY. AIR IN WHITE LUMEN WHEN PULLED BACK WITH SYRINGE. CNS HAS LINE. LEAKING."

  Patient problems: Insufficient Information

  MAUDE report 17914551 ↗
• MalfunctionOct 11, 2023Air/Gas in Device; Air/Gas in Device

  MEDWATCH FORM RECEIVED REPORTS: "RIJ INTRODUCER AND PA CATH PLACED VIA US GUIDANCE ON AND REMOVED 8 DAYS AFTER. AIR FROM BROWN PORT. MEDS RUNNING: PRECEDEX/HEPARIN/INSULIN/ NOREPINEPHRINE. CNS HAS LINE."

  Patient problems: Insufficient Information

  MAUDE report 17914326 ↗
• MalfunctionOct 11, 2023Air/Gas in Device; Air/Gas in Device

  MEDWATCH FORM RECEIVED REPORTS: "RIJ INTRODUCER DOUBLE LUMEN (SIZE NOT SPECIFIED) PA TO INTRODUCER IN OPERATING ROOM (OR) VIA US GUIDANCE AND REMOVED 5 DAYS LATER. CENTRAL LINE BROWN PORT PULLING BACK AIR AND ALERTING ECMO OF VENOUS BUBBLES. LINE WAS IN USE WITH LACTATED RINGERS' SOLUTION (LR) AND INSULIN RUNNING WITH NO PRIOR ISSUES. LINE NOT SAVED."

  Patient problems: Insufficient Information

  MAUDE report 17914200 ↗
• InjuryOct 11, 2023Fluid/Blood Leak; Fluid/Blood Leak

  MEDWATCH FORM RECEIVED REPORTS: "RIJ 9 FR DL INTRODUCER PLACED VIA US GUIDANCE AND REMOVED 2.5 WEEKS LATER. EXTRAVASATION NOTED AT RIGHT IJ CENTRAL VENOUS ACCESS CATHETER SITE WHILE PERFORMING SITE CARE; ACTUAL DATE OF EXTRAVASATION NOT CLEAR AS THERE ARE MULTIPLE EPISODES OF LEAKING CATHETER/SITE WITH DRESSING CHANGES PERFORMED FOR SEVERAL DAYS PRIOR; PATIENT RECEIVED VASOPRESSORS AND ANTIBIOTICS AT VARIOUS INTERVALS. CONSULT OF SITE REVEALED NO UNDERLYING NECROTIZING SOFT TISSUE INJURY BUT WILL NEED DEBRIDEMENT AT SOME TIME IN FUTURE. NON OBSTRUCTIVE CLOT OF RIJ SEEN ON CT SCAN OF NECK 2 DAYS POST REMOVAL. SITE BEING MONITORED. NO LINE SAVED."

  Patient problems: Extravasation; Scar Tissue

  MAUDE report 17914110 ↗
• MalfunctionOct 11, 2023Fluid/Blood Leak; Fluid/Blood Leak

  MEDWATCH FORM RECEIVED REPORTS: "RIJ INTRODUCER W/ PAC THROUGH IT PLACED VIA US WITH TEE, REMOVED 2 DAYS LATER. SAT PATIENT UP IN THE CARDIAC CHAIR MODE AND NOTED THE RIJ CORDIS SITE WAS LEAKING AND THE CHLORHEXIDINE GLUCONATE (CHG) OF THE TRANSPARENT DRESSING WAS SOAKED. EPINEPHRINE AND ISUPREL WERE INFUSING. BEDSIDE LUNG ULTRASOUND IN EMERGENCY (BLUE) ULTRASOUND DONE AND NOTED A LARGE OCCLUSIVE CLOT. EXTRAVASATION PROTOCOL FOLLOWED AND INJECTIONS DONE. CNS HAS LINE."

  Patient problems: Extravasation; Obstruction/Occlusion; Thrombosis/Thrombus

  MAUDE report 17913327 ↗
• MalfunctionOct 11, 2023Fluid/Blood Leak; Fluid/Blood Leak

  MEDWATCH FORM RECEIVED REPORTS: "RIJ CENTRAL VENOUS CATHETER (CVC) (TRIPLE LUMEN) PLACED US GUIDED AND THEN REMOVED 5 DAYS LATER. PATIENT HAD RIGHT IJ CVC CENTRAL LINE. OOZY AND NEEDING SEVERAL DRESSING CHANGES. NECK SITE PAINFUL, IRRITATED, MACERATED. PATIENT RECEIVED MULTIPLE DOSES OF PAIN MEDS, SITE REDRESSED, AND ICE APPLIED. SITE PINK/ MOIST IRRITATED NO EVIDENCE OF UNDERLYING TISSUE INJURY. LINE NOT SAVED."

  Patient problems: Pain; Skin Inflammation/ Irritation

  MAUDE report 17913307 ↗
• InjuryOct 11, 2023Obstruction of Flow; Obstruction of Flow

  MEDWATCH FORM RECEIVED REPORTS: "RIGHT INTERNAL JUGULAR (RIJ) QUAD LUMEN & RIJ DL INTRODUCER (NOT SPECIFIED SIZE) WITH PA CATH PLACED WITH US GUIDANCE AND REMOVED SIX DAYS LATER. RIGHT IJ DOUBLE WITH PA CATH AND RIGHT IJ QUAD LUMEN EXTRAVASATION. EPINEPHRINE, VASOPRESSORS, ISOPROTERENOL, CALCIUM CHLORIDE, AND INSULIN RUNNING THROUGH LINE. EXTRAVASATION PROTOCOL FOLLOWED. LINE REMOVED- INJURY WITH INCISION AND DRAINAGE (I & D) OF NECK REQUIRING FLAP 4 WEEKS AFTER. THE RIJ WAS THROMBOSED BASED ON COMPUTERIZED TOMOGRAPHY (CT) SCAN WHICH IS THE LIKELY CAUSE FOR EXTRAVASATION AS THE LINES WERE IN THE APPROPRIATE LOCATION. LINE NOT SAVED."

  Patient problems: Extravasation; Thrombosis/Thrombus

  MAUDE report 17913227 ↗
• MalfunctionOct 11, 2023Fluid/Blood Leak; Obstruction of Flow; Fluid/Blood Leak; Obstruction of Flow

  MEDWATCH FORM RECEIVED REPORTS: "LIJ 9 FR DL WITH CLIP IN TRIPLE LUMEN PLACED VIA US GUIDED AND TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE) AND THEN REMOVED 13 DAYS LATER. NOTED BACKFLOW OF MEDICATION/BLOOD IN ONE OF THE CAPPED/CLAMPED LUMENS AND PINKNESS AROUND THE INSERTION SITE. SKIN PROGRESSED TO LOCALLY EDEMATOUS AND REDDENED. THE PATIENT ALSO REPORTED PAIN AT THE SITE. SKIN PINK, MILD IRRITATION, NO EVIDENCE OF UNDERLYING TISSUE INJURY. LINE NOT SAVED."

  Patient problems: Pain; Skin Inflammation/ Irritation

  MAUDE report 17913095 ↗
• MalfunctionOct 11, 2023Fluid/Blood Leak; Fluid/Blood Leak

  MEDWATCH FORM RECEIVED REPORTS: "LEFT INTERNAL JUGULAR (LIJ) 9 FR INTRODUCER (DOUBLE LUMEN (DL)) WITH PULMONARY ARTERY CATHETER (PA) TO INTRODUCER PLACED ULTRASOUND (US) GUIDED AND THEN REMOVED SIX DAYS LATER. EXTRAVASATED AND LEFT NECK ECCHYMOSIS, BLACK COLOR. EXTRAVASATION PROTOCOL HAD BEEN DONE. LINE REMOVED-PLASTIC SURGERY FOLLOWING PATIENT. LINE NOT SAVED ".

  Patient problems: Extravasation

  MAUDE report 17912902 ↗
• MalfunctionSep 12, 2023Fluid/Blood Leak; Fluid/Blood Leak

  CUSTOMER REPORTED ISSUE WITH INTRODUCER HAVING FLUID COMING BACK UP INTO THE DISTAL SIDE PORT, AIR BUBBLES COMING UP THE PROXIMAL LINE, AND FLUID LEAKING FROM THE JUNCTURE HUB AT THE SKIN. IT WAS REPORTED THE CATHETERS WORK GREAT IN THE OR AND THEN 1-9 DAYS LATER EXPERIENCE THE ISSUE. THE INTRODUCER WAS REMOVED AND A DIFFERENT CATHETER WAS PLACED. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17729068 ↗
• MalfunctionSep 12, 2023Fluid/Blood Leak; Fluid/Blood Leak

  CUSTOMER REPORTED ISSUE WITH INTRODUCER HAVING FLUID COMING BACK UP INTO THE DISTAL SIDE PORT, AIR BUBBLES COMING UP THE PROXIMAL LINE, AND FLUID LEAKING FROM THE JUNCTURE HUB AT THE SKIN. IT WAS REPORTED THE CATHETERS WORK GREAT IN THE OR AND THEN 1-9 DAYS LATER EXPERIENCE THE ISSUE. THE INTRODUCER WAS REMOVED AND A DIFFERENT CATHETER WAS PLACED. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17729032 ↗
• MalfunctionSep 12, 2023Fluid/Blood Leak; Fluid/Blood Leak

  CUSTOMER REPORTED ISSUE WITH INTRODUCER HAVING FLUID COMING BACK UP INTO THE DISTAL SIDE PORT, AIR BUBBLES COMING UP THE PROXIMAL LINE, AND FLUID LEAKING FROM THE JUNCTURE HUB AT THE SKIN. IT WAS REPORTED THE CATHETERS WORK GREAT IN THE OR AND THEN 1-9 DAYS LATER EXPERIENCE THE ISSUE. THE INTRODUCER WAS REMOVED AND A DIFFERENT CATHETER WAS PLACED. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17728996 ↗
• MalfunctionSep 12, 2023Fluid/Blood Leak; Fluid/Blood Leak

  CUSTOMER REPORTED ISSUE WITH INTRODUCER HAVING FLUID COMING BACK UP INTO THE DISTAL SIDE PORT, AIR BUBBLES COMING UP THE PROXIMAL LINE, AND FLUID LEAKING FROM THE JUNCTURE HUB AT THE SKIN. IT WAS REPORTED THE CATHETERS WORK GREAT IN THE OR AND THEN 1-9 DAYS LATER EXPERIENCE THE ISSUE. THE INTRODUCER WAS REMOVED AND A DIFFERENT CATHETER WAS PLACED. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17728971 ↗
• MalfunctionAug 22, 2023Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THE DEVICE WAS INSERTED IN THE OR AND FLUID WAS NOTED TO BE LEAKING FROM "THE SKIN-INTRODUCER JUNCTION". IT WAS REPORTED THE NURSES SAID THE FLUIDS WERE COMING FROM THE PUNCTURE SITE AROUND THE CATHETER AND THE FLUID WAS MEDICATION. AN ADDITIONAL IV ACCESS WAS PLACED FOR MEDICATION ADMINISTRATION. NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17597019 ↗
• MalfunctionAug 2, 2023Fluid/Blood Leak; Fluid/Blood Leak

  THE COMPLAINT IS REPORTED AS: "ITEM ASK-21242-MMC1 HAD MEDICATION LEAKING FROM SKIN-CATHETER JUNCTION. FLUID INFUSING INTO BOTH WHITE AND BROWN SIDE-ARMS OF THE INTRODUCER, AND INTO THE WHITE LUMEN OF A CLIP-IN TRIPLE LUMEN STCVC THAT WAS PLACED THROUGH THE INTRODUCER." IT WAS REPORTED CLEVIDIPINE WAS RUNNING THROUGH ONE OF THE LUMENS AND LEAKING FROM THE JUNCTION SITE. THE CATHETER WAS INSERTED IN THE RIGHT INTERNAL JUGULAR VEIN ON (B)(6) 2023. ALL FLUIDS WERE MOVED TO THE CLIP-IN TRIPLE-LUMEN STCVC WITH SUCCESS (CESSATION OF LEAKING). NO PATIENT HARM WAS REPORTED. THE PATIENT'S CONDITION IS REPORTED AS FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17441885 ↗
• MalfunctionJul 6, 2023Leak/Splash; Improper Flow or Infusion; Leak/Splash; Improper Flow or Infusion

  IT WAS REPORTED WHEN TRYING TO PULL BACK, THERE WAS NO BLOOD RETURN IN BOTH WHITE AND BROWN LUMENS. BEFORE STARTING HIGH CONCENTRATION PRESSORS IN WHITE LUMEN THE NURSE NOTICED NO BLOOD RETURN, BUT NO ISSUES WITH FLUSHING THE LINE. THE NURSE WAS TOLD IT WAS OKAY TO RUN PRESSORS IN THE WHITE LUMEN. THE BROWN LUMEN HAD SINGLE STRENGTH PRESSORS RUNNING WHEN SWITCHING OVER TO HIGH CONCENTRATED PRESSORS. WHEN PULLING BACK BROWN LUMEN, THE NURSE NOTICED AIR IN TUBING WITH NO BLOOD RETURN, THE 10CC PLUNGER WOULD FILL UP WITH AIR ALONG WITH PRESSOR MEDICATION. THE CVC HAD BEEN INSERTED IN THE RIGHT JUGULAR FOR ONE DAY AND THE ISSUE WAS IDENTIFIED UPON ARRIVAL FROM OR. NO PATIENT HARM WAS REPORTED. THE BROWN LUMEN WAS MARKED AS "DO NOT USE", BUT THE INTRODUCER WAS KEPT IN PLACE AND WHITE LUMEN USED. THE CENTRAL LINE WAS REMOVED NINE DAYS LATER. THE PATIENT'S CONDITION IS REPORTED AS FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17273595 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K011761. One submission often covers many models, so check the product and lot details in each record.

• Z-2385-2026 · Apr 21, 2026 · Open, Classified
  Description/REF: ACCESS TRAY/GU-04020; PSI KIT: 8.5 FR/AK-09803-CDC; PSI KIT: 9 FR/AK-09903-CDC; PSI KIT: 8.5 FR X 4 IN (10 CM)/ASK-09810-PCMH1; PSI KIT: 9 FR X 10 CM/ASK-09903-KH;
• Z-2555-2019 · Aug 6, 2019 · Terminated
  8.5 Fr. X 10 cm ARROW+gard Blue PSI Kit Cath-Gard for use with 7.5 - 8 Fr.Catheters Product Code: CDC-29803-1A - Product Usage: The MACTM Two-Lumen Central Venous Access Device wit
• Z-1983-2018 · Apr 11, 2018 · Terminated
  MAC(TM) Two-Lumen Central Venous Access Kit with ARROWg+ard Blue(R) Access Device, Integral Hemostasis Valve and Sharps Safety Features for use with 7.5 - 8 Fr. Catheters; Product
• Z-1324-2018 · Dec 22, 2017 · Terminated
  (1) ARROWg+ard Blue(R) MAC(TM) Two-Lumen Central Venous Access Kit for use with 7.5 - 8 Fr. Catheters, Product Number: ASK-21142-RH; (2) Arrowg+ard Blue(R) MAC(TM) Two-Lumen Centra
• Z-1002-2018 · Nov 27, 2017 · Terminated
  ARROWg+ard Blue Product Usage: The Arrow CVC is indicated to provide short-term (< 30 days) central venous access for treatment of diseases or conditions requiring central venous
• Z-1000-2018 · Nov 27, 2017 · Terminated
  ARROWg+ard Blue MAC" Two-Lumen Central Venous Access Kit Product Usage: The Arrow CVC is indicated to provide short-term (< 30 days) central venous access for treatment of disease
• Z-2333-2017 · May 9, 2017 · Terminated
  1) ARROWg+ard Blue MAC Two-Lumen Central Venous Access Kit 2) ARROWg+ard Blue PSI Kit 3) ARROWg+ard Blue MAC Two-Lumen Central Venous Access Kit 4) ARROWg+ard Blue PSI Kit The MACT
• Z-2825-2015 · Aug 27, 2015 · Terminated
  Arrow Kits with Medtronic Covidien 0.9% Sodium Chloride Flush Syringes
• Z-0066-2015 · Aug 6, 2014 · Terminated
  Arrow Select Kits (ASK) and Maximal Barrier Precautions Kits (CDC) with BD Medical Posiflush 10mL Saline Flush Syringe.
• Z-0783-2010 · Nov 24, 2009 · Terminated
  MAC (TM) Two Lumen Central Venous Access Kit with ARROWg+ard Blue (R) Access Device, Integral Hemostasis Valve, Sharps Safety Features and Maximal Barrier Precautions for use with