Groshong 7711800Recalls & reported problems
Bard Access Systems, Inc. · Groshong 8F Single-Lumen CV Catheter with SureCuff Tissue Ingrowth Cuff Intermediate Tray · Class 2 · Implant
All models of Groshong (12)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 17
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 00801741036743), received between Jun 1, 2017 and Feb 9, 2026 — classified as 3 injuries, 14 malfunctions.
The most frequently reported specific device problem is “Break” (4 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
Most reported problems
Device problems
- Break4
- Adverse Event Without Identified Device or Use Problem2
- Defective Component2
- Fluid/Blood Leak2
- Fracture2
- Tear, Rip or Hole in Device Packaging2
- Aspiration Issue1
- Component Missing1
Patient problems
- No Known Impact Or Consequence To Patient5
- No Clinical Signs, Symptoms or Conditions4
- No Consequences Or Impact To Patient4
- Hypersensitivity/Allergic reaction2
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
- Complaint, Ill-Defined1
- Extravasation1
- No Patient Involvement1
Recent adverse event reports
The 17 most recent of 17 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 9, 2026Stretched; Physical Resistance/Sticking
A PATIENT UNDERWENT A CATHETER PLACEMENT PROCEDURE USING THE GROSHONG CENTRAL VENOUS CATHETER. DURING THE PROCEDURE, THE GUIDEWIRE BECAME ALLEGEDLY STUCK INSIDE THE INTRODUCER NEEDLE FROM THE SINGLE LUMEN KIT THAT HAD BEEN OPENED FOR THE CASE. THE WIRE UNCOILED. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24289566 ↗MalfunctionAug 23, 2024Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging
IT WAS REPORTED THAT PRIOR TO A CHRONIC CATHETER PLACEMENT PROCEDURE. THE DEVICE PACKAGE WAS ALLEGEDLY DAMAGED WITH A HOLE IN THE BOX. THERE WAS NO PATIENT CONTACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20050044 ↗InjuryAug 25, 2021Fluid/Blood Leak; Fracture; Fluid/Blood Leak; Fracture
IT WAS REPORTED THAT DURING A PROCEDURE, THE DEVICE ALLEGEDLY WAS NON FUNCTIONING AND IT WAS FURTHER REPORTED THAT THE DEVICE WAS NOTED TO BE FRACTURED. UPON DYE STUDY, FLUID EXTRAVASATION WAS NOTED ON THE DEVICE. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.
Patient problems: Extravasation; No Clinical Signs, Symptoms or Conditions
MAUDE report 12363925 ↗InjuryMay 31, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT SOME TIME POST CATHETER PLACEMENT, THE PATIENT ALLEGEDLY EXPERIENCED AN ALLERGIC REACTION. THE CURRENT PATIENT STATUS IS UNKNOWN.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Hypersensitivity/Allergic reaction
MAUDE report 11906215 ↗MalfunctionApr 12, 2021Component Missing; Tear, Rip or Hole in Device Packaging; Component Missing; Tear, Rip or Hole in Device Packaging
IT WAS REPORTED THAT UPON RECEIVING THE PACKAGE, STERILE BARRIER OF THE PACKAGE ALLEGEDLY BREACHED. THERE WAS NO PATIENT CONTACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11647288 ↗MalfunctionJul 17, 2020Nonstandard Device; Nonstandard Device
THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATES THAT MODEL 7711800 CHRONIC CATHETER ALLEGEDLY EXPERIENCED NONSTANDARD DEVICE. THIS REPORT WAS RECEIVED FROM ONE SOURCE. ONE PATIENT WAS INVOLVED WITH NO PATIENT CONTACT. THE PATIENTS¿ AGE, WEIGHT, AND GENDER WERE NOT PROVIDED.
Patient problems: No Patient Involvement
MAUDE report 10289338 ↗MalfunctionJul 16, 2020Break; Fracture; Material Separation; Break; Fracture; Material Separation
THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL 7711800 CHRONIC CATHETER ALLEGEDLY BROKE. THIS INFORMATION WAS RECEIVED FROM ONE SOURCE. THIS MALFUNCTION INVOLVED PATIENT WITH NO KNOWN IMPACT TO THE PATIENT. THE PATIENT WAS 56-YEARS OLD MALE AND WEIGHED 327 LBS.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10283927 ↗MalfunctionJul 24, 2019Defective Component; Defective Component
THIS REPORT SUMMARIZES THREE MALFUNCTIONS. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL 7711800. CENTRAL VENOUS CATHETER ALLEGEDLY HAD DEFECTIVE COMPONENTS. THESE REPORTS WERE RECEIVED FROM VARIOUS SOURCES. ALL THREE EVENTS HAD NO REPORTED PATIENT INJURY. THE MALFUNCTIONS INVOLVED PATIENTS WITHOUT CONSEQUENCE. THREE PATIENTS AGE RANGED FROM 17-44 YEARS, FEMALES, AND WEIGHT RANGED FROM 37-102 KGS.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8822398 ↗MalfunctionNov 21, 2018Defective Component; Defective Component
IT WAS REPORTED THAT THE CUFF OF A CHRONIC CATHETER ALLEGEDLY FELL OFF THE CATHETER. IT WAS FURTHER REPORTED THAT A NEW DEVICE WAS PLACED. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8095694 ↗MalfunctionFeb 28, 2018Crack; Fluid/Blood Leak
IT WAS REPORTED THAT PATIENT'S TUNNELLED GROSHONG WAS INSERTED IN INTERVENTIONAL RADIOLOGY ON (B)(6) 2018. ON (B)(6) 2018 THE PATIENT CONTACTED HOME HEALTH AS SHE REPORTED THAT HER TPN INFUSION OVERNIGHT HAD ALLEGEDLY LEAKED ALL OVER HER. PATIENT MADE A VISIT TO HOME HEALTH TO HAVE HER CVC DRESSING CHANGED AS IT WAS ALLEGEDLY ALL WET AND THE NURSE DISCOVERED THAT THERE WAS AN ALLEGED CRACK IN THE TUBE BETWEEN THE INSERTION SITE AND THE HUB OF THE GROSHONG AND FLUID WAS LEAKED. THE PATIENT WENT TO HOSPITAL ON THE SAME DAY AND HAD THE GROSHONG REPAIRED. NO PATIENT INJURY REPORTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7304502 ↗InjuryFeb 27, 2018Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED BY THE FACILITY THAT THE PATIENT HAD A POWERPICC PLACED AND HAD "SOME SORT OF ALLERGIC REACTION". THE PICC WAS REMOVED AND A GROSHONG CVC WAS PLACED. IT WAS REPORTED THAT CHLORAPREP WAS USED BEFORE AND AFTER BOTH INSERTIONS. THIS FILE ADDRESSES THE REACTION TO THE GROSHONG CVC CATHETER. ON (B)(6) 2018 - ADDITIONAL INFORMATION REPORTED BY THE FACILITY THAT THE PATIENT HAD RASH AND HIVES AFTER PLACEMENT OF THE POWERPICC.
Patient problems: Hypersensitivity/Allergic reaction; Rash; Urticaria
MAUDE report 7301011 ↗MalfunctionNov 10, 2017Aspiration Issue
PATIENT REPORTED THAT SHE HAD A GROSHONG CVC PLACED IN (B)(6) OF 2017. THE CATHETER INFUSES WITHOUT ANY PROBLEM, BUT IS UNABLE TO ASPIRATE. PHYSICIAN PERFORMED A DYE STUDY INDICATED THE CATHETER TIP TO BE IN THE CORRECT LOCATION AND HAS NO DIFFICULTIES FLUSHING THE PORT, BUT IS STILL UNABLE TO OBTAIN BLOOD RETURN. PATIENT STATED THE PHYSICIAN TOLD HER THE CATHETER WAS PLACED IN THE SUBCLAVIAN, BUT IS SURE THE LACK OF BLOOD RETURN IS NOT CAUSED BY PINCH OFF.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7023096 ↗MalfunctionNov 1, 2017Break
IT WAS REPORTED BY THE FACILITY THAT THE DOCTOR COULDN'T INSERT THE GROSHONG, AS THE TIP "FELL OFF". ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT INJURY REPORTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6993493 ↗MalfunctionOct 18, 2017Device Operates Differently Than Expected
PATIENT REPORTED TO MEDICAL SERVICES & SUPPORT THAT SHE HAD A GROSHONG CVC PLACED IN 2007, AND THE CATHETER NEEDS TO BE REPAIRED DUE TO HOME HEALTHCARE "MESSING" UP THE CATHETER. THE CATHETER WILL FLUSH AND ASPIRATE WITH OUT ISSUE, HOWEVER, PATIENT IS HAVING BLEED BACK. PATIENTS STATES SHE WAS INFORMED THAT THE CATHETER WAS OBSOLETE. SHE CONTACTED MS&S INQUIRING ABOUT A YELLOW CONNECTOR AS SHE HAS 3 INCHES OF CATHETER THAT COULD BE REPAIRED. PATIENT IS SCHEDULED TO SEE HER PHYSICIAN TO HAVE HER GROSHONG CVC EVALUATED FOR REPAIR OR REPLACEMENT. MS&S ADVISED THE PATIENT THAT THE DEVICE IS NOT OBSOLETE. NO PATIENT INJURY WAS REPORTED.
Patient problems: Complaint, Ill-Defined
MAUDE report 6959943 ↗MalfunctionSep 7, 2017Device Dislodged or Dislocated
IT WAS REPORTED THAT SUTURES AND WING WERE REMOVED ACCORDING TO STANDARDS SET BY THE DEPARTMENT PLACING THE CATHETERS. SOME DAY LATER, THE CATHETER LOOSENS AND SLIDES OUT, THE CUFF IS LEFT AND IS EASY TO PALPATE UNDER THE SKIN. THE PATIENT STATES THAT HE HAS NOT PULLED THE CATHETER. NO PATIENT INJURY WAS REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6850039 ↗MalfunctionAug 17, 2017Break; Leak/Splash
IT WAS REPORTED THAT THE GROSHONG LINE WAS PLACED BUT APPEARED TO BE DAMAGED ON THE FINAL CHECK. THE CATHETER WAS REMOVED AND A SECOND LINE PLACED. AFTER REMOVAL, IT WAS STATED THAT FLUID COULD BE SEEN LEAKING FROM UNDER THE CUFF.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6800213 ↗MalfunctionJun 1, 2017Break
THE FACILITY REPORTED THAT THE CATHETER "FELL APART" UPON REMOVAL. NO OTHER INFORMATION WAS KNOWN BUT HAS BEEN REQUESTED. NO PATIENT INJURY WAS REPORTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6606228 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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