ARROW IPN918400Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10801902179286), received between Aug 8, 2023 and Apr 17, 2026 — classified as 2 injuries, 7 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (2 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. 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 17, 2026Failure to Advance; Physical Resistance/Sticking

  IT WAS REPORTED THAT: "UNABLE TO FLOAT SWAN CATHETER THROUGH THE MAC. A NEW KIT WAS OPENED FOR THE SWAN SHEATH TO BE REPLACED. THERE WAS NO REPORTED PATIENT HARM." ASSOCIATED COMPLAINT 9680794-2026-00322.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24910180 ↗
• MalfunctionDec 26, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT "THE MAC WAS INDWELLING WITHIN THE PATIENT WHEN THE NURSE PULLED BACK ON THE LUMEN AND HAD NO BLOOD RETURN. WHEN THE NURSE DID GET BLOOD RETURN, BUBBLES WERE OBSERVED. ONE HOUR LATER THE NURSE NOTICED WETNESS ON THE PATIENT'S SKIN. THE NURSE FLUSHED THE CATHETER AND NOTICED SWELLING WITHIN THE PATIENT'S NECK. THE DECISION WAS MADE TO REMOVE THE CATHETER DUE TO CONCERN OVER POSSIBLE INFILTRATION AND/OR CATHETER DAMAGE". NO PATIENT HARM OR INJURY. THE PATIENT STATUS IS REPORTED AS "FINE".

  Patient problems: Extravasation

  MAUDE report 23896318 ↗
• MalfunctionNov 19, 2025Complete Blockage; Complete Blockage

  IT WAS REPORTED THAT "MAC INSERTED AND USED IN CVOR SURGERY THEN PATIENT TRANSPORTED TO CVICU. CVICU REPORTED CLOT IN DISTAL (BROWN) LUMEN WITHIN 30 MINUTES OF ARRIVAL AND CANNOT ASPIRATE THROUGH WHITE PROXIMAL LUMEN". ADDITIONAL INFORMATION RECEIVED STATES THAT THERE WAS NO PATIENT HARM OR INJURY. A NEW CATHETER WAS NOT INSERTED. THE PATIENT STATUS IS REPORTED AS "FINE'.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23596344 ↗
• MalfunctionOct 15, 2025Break; Break

  IT WAS REPORTED THAT "WE HAVE A KIT THAT HAD A BROKEN COMPONENT IF IT WHEN OPENED." THIS WAS FOUND PRIOR TO USE. THERE WAS NO PATIENT INVOLVEMENT. THE USER CHANGED TO A NEW DEVICE TO COMPLETE THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23278496 ↗
• MalfunctionAug 9, 2024Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT "THE CENTRAL LINE WAS PLACED IN THE OR BY ANESTHESIA ON (B)(6) 2024. WHILE TRYING TO DRAW LABS ON (B)(6) 2024, THE RN NOTICED THAT WHILE TRYING TO PULL BACK FROM THE INTRODUCER PORT, ALL SHE COULD DRAW BACK WAS AIR. THE LINE WAS INSPECTED AND USING A 10 ML SYRINGE APPROXIMATELY 100 ML OF AIR WAS REMOVED. ALL OF THE OTHER LUMENS PULLED BACK BLOOD WITH NO ISSUE. THE PATIENT HAD NO SUBCUTANEOUS AIR PALPABLE". ASSOCIATED COMPLAINTS (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 19948500 ↗
• MalfunctionAug 9, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT "THE CENTRAL LINE WAS PLACED IN THE OR BY ANESTHESIA ON (B)(6) 2024. WHILE TRYING TO DRAW LABS ON (B)(6) 2024, THE RN NOTICED THAT WHILE TRYING TO PULL BACK FROM THE INTRODUCER PORT, ALL SHE COULD DRAW BACK WAS AIR. THE LINE WAS INSPECTED AND USING A 10 ML SYRINGE APPROXIMATELY 100 ML OF AIR WAS REMOVED. ALL OF THE OTHER LUMENS PULLED BACK BLOOD WITH NO ISSUE. THE PATIENT HAD NO SUBCUTANEOUS AIR PALPABLE". ASSOCIATED COMPLAINTS 9680794-2024-00755, 9680794-2024-00754 AND 9680794-2024-00753

  Patient problems: Insufficient Information

  MAUDE report 19948490 ↗
• MalfunctionAug 9, 2024Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT "THE CENTRAL LINE WAS PLACED IN THE OR BY ANESTHESIA ON 3/8/24. WHILE TRYING TO DRAW LABS ON 3/11/24, THE RN NO TICED THAT WHILE TRYING TO PULL BACK FROM THE INTRODUCER PORT, ALL SHE COULD DRAW BACK WAS AIR. THE LINE WAS INSPECTED AND USING A 10 ML SYRINGE APPROXIMATELY 100 ML OF AIR WAS REMOVED. ALL OF THE OTHER LUMENS PULLED BACK BLOOD WITH NO ISSUE. THE PATIENT HAD NO SUBCUTANEOUS AIR PALPABLE".

  Patient problems: Insufficient Information

  MAUDE report 19948269 ↗
• InjuryFeb 8, 2024Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  IT WAS REPORTED THAT: PATIENT CODED TWICE AND HAD A CHLORHEXIDINE ALLERGIC REACTION. ADDITIONAL INFORMATION: IT WAS KNOWN THAT THE PATIENT HAD A CHG ALLERGY PRIOR TO THE PROCEDURE. HE HAD A PREVIOUS ARREST DURING A CABG BECAUSE OF THE ALLERGY. PRECAUTIONS WERE TAKEN WITH MEDICATION SELECTION AND AVOIDING ANY CHG SCRUBS OR CLEANERS FOR THE SURGERY. WHEN THE SHEATH WAS INSERTED THE PATIENT BECAME TACHYCARDIC AND HYPOTENSIVE. ONCE THE REACTION STARTED, HE WAS TREATED WITH BOLUS OF EPINEPHRINE AND A GTT WAS STARTED ALONG WITH VASOPRESSIN, COMPRESSIONS WERE STARTED FOR PERFUSION ONLY AS THE PATIENT DID NOT LOSE PULSE. ONCE THE SURGICAL TEAM REALIZED IT WAS THE SHEATH IT WAS REMOVED IMMEDIATELY AND REPLACE WITH A SHEATH THAT WAS NOT COATED. THE PATIENT WAS TRANSFERRED TO ICU FOLLOWING THE PROCEDURE WITH HEMODYNAMICS THAT WOULD BE WITHIN NORMAL LIMITS AFTER A CABG, MEANING THAT HE REQUIRED A LITTLE EXTRA BLOOD PRESSURE SUPPORT INITIALLY BUT WAS ABLE TO BE WEANED OFF. THE PATIENT DID DEVELOP AN ILEUS AFTER THE PROCEDURE BUT WAS UNLIKELY AS A RESULT OF THE ANAPHYLAXIS EVENT. THERE WAS NO FURTHER HEALTH CONSEQUENCES. THE PATIENT HAS BEEN DISCHARGED HOME WITH HOME HELP.

  Patient problems: Hypersensitivity/Allergic reaction; Low Blood Pressure/ Hypotension; Tachycardia

  MAUDE report 18666318 ↗
• InjuryAug 8, 2023Biocompatibility; Biocompatibility

  MEDWATCH REPORT RECEIVED: "PATIENT (PT) HAD MULTIPLE KNOWN ALLERGIES AND UNDERWENT ALLERGY TEST FOLLOWING RECENT ANAPHYLACTIC REACTION AFTER INTUBATION. SURGERY CANCELLED AND ALLERGY TESTING DONE REVEALED CHG (CHLORHEXIDINE GLUCONATE) ALLERGY. TWO MONTHS LATER, RETURNED TO OR. AFTER CENTRAL LINE PLACED - DEVELOPED HYPOTENSION, TREATED FOR ANAPHYLAXIS. SUSPECTED SOURCE CENTRAL LINE - CHLORHEXIDINE COATING. PATIENT PREPPED WITH BETADINE FOR BOTH LINE INSERTIONS. LINE REMOVED. NEW NON-COATED CHG INSERTED. DECISION TO PROCEED WITH SURGICAL PROCEDURE. PT REQUIRED 125 MG OF SOLU-CORTEF AND HAD ALREADY REC'D DECADRON FOR PONV (POSTOPERATIVE NAUSEA AND VOMITING) PRIOR TO ANAPHYLACTIC EPISODE."

  Patient problems: Anaphylactic Shock; Angioedema; Low Blood Pressure/ Hypotension; Renal Impairment; Urinary Retention

  MAUDE report 17479789 ↗

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