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Groshong NXT Catheter 7827505Recalls & reported problems

Bard Access Systems, Inc. · GRO NXT, 45 cm, D/L · Class 2 · Implant

All models of Groshong NXT Catheter (11)

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Adverse event reports
7
Deaths reported
0
Injuries reported
2
Recalls naming it
0

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00801741035340), received between Feb 18, 2016 and Jul 29, 2026 — classified as 2 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (3 reports).

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 18, 2026.

Reports received per month

Nov 2023: 0 reportsDec 2023: 0 reportsJan 2024: 0 reportsFeb 2024: 0 reportsMar 2024: 0 reportsApr 2024: 0 reportsMay 2024: 0 reportsJun 2024: 0 reportsJul 2024: 0 reportsAug 2024: 0 reportsSep 2024: 0 reportsOct 2024: 0 reportsNov 2024: 0 reportsDec 2024: 0 reportsJan 2025: 0 reportsFeb 2025: 0 reportsMar 2025: 0 reportsApr 2025: 0 reportsMay 2025: 0 reportsJun 2025: 0 reportsJul 2025: 0 reportsAug 2025: 0 reportsSep 2025: 0 reportsOct 2025: 0 reportsNov 2025: 0 reportsDec 2025: 0 reportsJan 2026: 0 reportsFeb 2026: 0 reportsMar 2026: 0 reportsApr 2026: 0 reportsMay 2026: 0 reportsJun 2026: 0 reportsJul 2026: 1 reportsAug 2026: 0 reportsSep 2026: 0 reportsOct 2026: 0 reports2024202520261
Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

  • Fluid/Blood Leak3
  • Adverse Event Without Identified Device or Use Problem2
  • Break1
  • Leak/Splash1
  • Material Puncture/Hole1

Patient problems

  • No Consequences Or Impact To Patient2
  • No Known Impact Or Consequence To Patient2
  • No Clinical Signs, Symptoms or Conditions1
  • Paralysis1
  • Thrombus1
  • Unspecified Infection1

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

  • InjuryJul 29, 2026Adverse Event Without Identified Device or Use Problem

    It was reported through the litigation process that, sometime after the port placement, the patient was diagnosed with an unspecified infection. However, the current status of the patient was unknown.

    Patient problems: Unspecified Infection

    MAUDE report 50072963 ↗
  • MalfunctionNov 30, 2021Fluid/Blood Leak; Fluid/Blood Leak

    IT WAS REPORTED THAT 4 FR GROSHONG DOUBLE LUMEN PICC LINE PUNCTURED. NO OTHER INFORMATION WAS PROVIDED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 12901677 ↗
  • InjuryMay 21, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    PATIENT REPORTED THAT HE HAS BEEN "SUFFERING WITH THE CATHETER" SINCE OCTOBER. NO OTHER INFORMATION AT THIS TIME. (B)(6)2020 - PATIENT REPORTED THE FOLLOWING ADDITIONAL INFORMATION: "I AM SUFFERING FROM ECHOGENIC THROMBUS. LAST YEAR (B)(6) DURING MONTH OF AUGUST I WENT TO INDIA FOR CANCER TREATMENT, AND IN THE HOSPITAL THE DOCTOR DECIDED TO FIX ONE CATHETER IN MY LEFT ARM, AND ALL THE TREATMENT OF THE CHEMOTHERAPY WERE GOING BY THIS CATHETER, BUT JUST AFTER FEW TREATMENT THE CATHETER GOT BLOCKED AND ULTRASOUND WAS DONE AND THROMBUS WAS FOUND DUE TO THE BLOCKED CATHETER AND I HAD TO GO BACK TO INDIA TO REMOVE THE CATHETER AND TO TREAT THE DAMAGES. ACTUALLY DAILY I HAVE TO TAKE TWO TABLETS OF PRADAXA OF 150 MG, WHICH IS NOT AVAILABLE TO GET EASY AND THIS TABLETS FOR ME IS VERY EXPENSIVE, I AM NOT ABLE TO WORK AND SURVIVE WITH AND OLD PERSON PENSION OF GOVERNMENT, I HAVE NOW MY LEFT ARM PARALYZED AND CAN NOT USE OF IT AND IF I STOP TAKING THIS TABLETS I WILL DIE BY STROKE. THE REPORT OF THE ULTRASOUND OF RADIOLOGIST DOCTOR X SAID LUMEN OF LT INTERNAL JUGULAR VEIN APPEARS DECREASED IN DIAMETER WITH THE PRESENCE OF AN ECHOGENIC THROMBUS SEEN PROXIMAL LT INTERNAL JUGULAR ( CAUDO-CRANIAL

    Patient problems: Paralysis; Thrombus

    MAUDE report 10080760 ↗
  • MalfunctionMay 12, 2020Fluid/Blood Leak; Fluid/Blood Leak

    IT WAS REPORTED THAT THE PICC LINE INSERTED BY CONSULTANT ANAESTHETIST ON SUBSEQUENT INVESTIGATION FOR CT -RADIOLOGIST NOTICED THAT ALL THORAX VESSELS WERE NOT AS ENHANCED AS EXPECTED AND THERE WAS SUSPICION THAT PICC WAS NOT FUNCTIONING PROPERLY SO IT WAS REMOVED. ON CLOSE EXAMINATION OF PICC WAS FOUND TO HAVE A HOLE IN THE MIDLINE. NO HARM TO PATIENT OR HEALTHCARE PROFESSIONAL.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 10049783 ↗
  • MalfunctionApr 8, 2020Fluid/Blood Leak; Fluid/Blood Leak

    IT WAS REPORTED PATIENT ATTENDED FOR A CT SCAN WITH THIS LINE IN. DURING THE SCAN IT WAS NOTED BY THE RADIOLOGIST THAT THE CONTRAST AGENT USED WAS NOT OPTIMAL (THE PICC LINE WAS USED TO ADMINISTER THE CONTRAST) THE RADIOLOGIST DECIDED TO REMOVE THE PICC AND ON CLOSE INSPECTION WAS FOUND TO HAVE A SMALL HOLE MIDLINE.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 9937647 ↗
  • MalfunctionJun 7, 2019Leak/Splash; Material Puncture/Hole

    IT WAS REPORTED THAT RIGHT ARM PICC THAT WAS INSERTED (B)(6) 2019 ALLEGEDLY FOUND TO BE LEAKING AND REMOVED (B)(6) 2019 BY CCU NURSE AND RETAINED FOR PICC TEAM TO ASSESS. UPON INSPECTION WITH FLUSHING, PINHOLE LEAK SUPPOSEDLY NOTICED JUST BELOW THE HUB.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 8679464 ↗
  • MalfunctionFeb 18, 2016Break

    IT WAS REPORTED THAT THE BLUE TUBING (CATHETER) IS ALLEGEDLY SNAPPING/BREAKING OFF RIGHT WHERE IT STARTS. THERE WERE APPARENTLY 3 INCIDENTS IN THE PAST MONTH.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 5446033 ↗

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Sources and updates

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