Groshong 7726950Recalls & reported problems
Bard Access Systems, Inc. · Groshong 9.5F Dual-Lumen CV Catheter with SureCuff Tissue Ingrowth Cuff Intermediate Tray · Class 2 · Implant
All models of Groshong (12)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
Quick summary
This is a Groshong dual-lumen central venous catheter, a short-term tube placed through a vein for infusions and blood draws. The 38 reports mostly describe the line breaking, cracking or separating, along with leaks of fluid or blood; a few also describe infections such as bacteremia. There are no deaths and 6 injuries. No recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 38
- Deaths reported
- 0
- Injuries reported
- 6
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 38 adverse event reports that list this exact device (DI 00801741041570), received between Dec 28, 2015 and Nov 28, 2024 — classified as 6 injuries, 32 malfunctions.
The most frequently reported specific device problem is “Break” (9 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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Break9
- Fluid/Blood Leak7
- Detachment Of Device Component5
- Fracture5
- Hole In Material3
- Leak/Splash3
- Adverse Event Without Identified Device or Use Problem2
- Component Falling2
Patient problems
- No Known Impact Or Consequence To Patient19
- No Clinical Signs, Symptoms or Conditions6
- No Consequences Or Impact To Patient6
- Unspecified Infection4
- Bacteremia1
- Chemical Exposure1
- No Information1
Recent adverse event reports
The 25 most recent of 38 reports, in the reporter's own words as published by the FDA.
InjuryNov 28, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THROUGH LITIGATION PROCESS THAT THREE MONTHS AND FOUR DAYS POST A CENTRAL VENOUS CATHETER PLACEMENT, THE PATIENT ALLEGEDLY DEVELOPED WITH BACTEREMIA. REPORTEDLY, THE CATHETER WAS REMOVED AND REPLACED. HOWEVER, THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.
Patient problems: Bacteremia
MAUDE report 20803778 ↗InjuryNov 27, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THROUGH LITIGATION PROCESS THAT ABOUT SOMETIME POST A CENTRAL VENOUS CATHETER PLACEMENT, THE PATIENT ALLEGEDLY DEVELOPED WITH INFECTION. HOWEVER, THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.
Patient problems: Unspecified Infection
MAUDE report 20794556 ↗MalfunctionNov 18, 2024Fluid/Blood Leak; Material Puncture/Hole; Fluid/Blood Leak; Material Puncture/Hole
IT WAS REPORTED THAT SIX MONTHS AND TWENTY-EIGHT DAYS POST A CHRONIC CATHETER PLACEMENT, LEAK WAS ALLEGEDLY NOTED FROM THE EXIT SITE AND WHEN REMOVED IT WAS NOTED AROUND THE CUFF AREA. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20703481 ↗MalfunctionApr 3, 2023Fracture; Fracture
IT WAS REPORTED THAT DURING A CHRONIC CATHETER PLACEMENT PROCEDURE, THE CATHETER ALLEGEDLY HAD A SMALL NICK IN THE LINE NEAR THE HUB. REPORTEDLY THE CATHETER WAS REPLACED. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16664244 ↗MalfunctionSep 8, 2022Fracture; Air/Gas in Device; Fracture; Air/Gas in Device
IT WAS REPORTED THAT APPROXIMATELY ONE YEAR POST CATHETER PLACEMENT PROCEDURE, THE CATHETER ALLEGEDLY ASPIRATED AIR FROM LINE REPEATEDLY. REPORTEDLY, THE CATHETER WAS REMOVED. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15378478 ↗MalfunctionMar 24, 2021Difficult to Flush; Suction Problem; Difficult to Flush; Suction Problem
IT WAS REPORTED THAT DURING CHRONIC CATHETER PLACEMENT PROCEDURE, THE PORT ALLEGEDLY FAILED TO FLUSH AND RETURN BLOOD. IT WAS FURTHER REPORTED THAT THE ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11560543 ↗MalfunctionDec 15, 2020Deformation Due to Compressive Stress; Material Deformation; Deformation Due to Compressive Stress; Material Deformation
IT WAS REPORTED THAT DURING THE PROCEDURE, THE CATHETER ALLEGEDLY KINKED. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11010931 ↗MalfunctionNov 12, 2020Fracture; Material Separation; Fracture; Material Separation
IT WAS REPORTED THAT DURING A CATHETER PLACEMENT, THE CATHETER BROKE INTO SEVERAL PIECES. IT WAS FURTHER REPORTED THAT ALL BROKEN PIECES WERE REMOVED FROM THE PATIENT. THE PROCEDURE WAS COMPLETED BY USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 10828117 ↗MalfunctionAug 10, 2020Break; Fracture; Nonstandard Device; Break; Fracture; Nonstandard Device
IT WAS REPORTED THAT POST PORT IMPLANT THE PATIENT ALLEGEDLY EXPERIENCED BREAK ON THE RED LEG. IT WAS FURTHER REPORTED THAT THE PATIENT SEES THAT THE AIR IN THE LINE HAS PASSED HER CLAMP AND IS NOW AT THE LEVEL OF HER BODY. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10383603 ↗MalfunctionMar 19, 2020Break; Fracture; Break; Fracture
IT WAS REPORTED THAT DURING TUNNELING, THE CATHETER ALLEGEDLY BROKE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9855603 ↗MalfunctionJul 17, 2019Backflow; Backflow
THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL 5829502. PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR ALLEGEDLY EXPERIENCED BACKFLOW. THIS REPORT WAS RECEIVED FROM A SINGLE SOURCE. THIS EVENT DID INVOLVE PATIENT WITH NO REPORTED PATIENT INJURY. AGE, WEIGHT, AND GENDER WERE NOT PROVIDED FOR THE PATIENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8801019 ↗MalfunctionOct 10, 2018Defective Component; Defective Component
IT WAS REPORTED THAT WHILE FLUSHING THE CATHETER THE WHITE WINGED CONNECTOR DISCONNECTED. THE WINGED CONNECTOR WAS CLEANED AND REATTACHED, IT WAS IDENTIFIED THAT THERE WAS NO CONNECTOR LOCKING SLEEVE IN PLACE ON EITHER LUMEN. THE CATHETER WAS REMOVED. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7953658 ↗MalfunctionAug 14, 2018Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT WHEN THE NURSE ATTEMPTED TO FLUSH THE LINE, THE WING CONNECTOR FELL OFF. ANOTHER CONNECTOR WAS ATTACHED TO THE CATHETER TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7782173 ↗MalfunctionAug 1, 2018Break; Break
IT WAS REPORTED THAT THE CATHETER BROKE DURING THE INSERTION PROCESS. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7741387 ↗MalfunctionJun 20, 2018Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT DURING CATHETER FLUSH, THE PATIENT'S GOWN WAS WET, THE LINE WAS EXAMINED AND FOUND TO HAVE A LEAK. THE CATHETER WAS REPAIRED SO THE PATIENT COULD CONTINUE TREATMENT AND WAS REMOVED IN INTERVENTIONAL RADIOLOGY AFTER TREATMENT WAS COMPLETE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7623453 ↗InjuryMar 21, 2018Insufficient Device Problem Information
IT WAS REPORTED THAT THE FACILITY HAS SEEN AN INCREASE IN INFECTIONS WITH THE GROSHONG CATHETERS. NO OTHER INFORMATION WAS REPORTED, BUT HAS BEEN REQUESTED.
Patient problems: Unspecified Infection
MAUDE report 7360126 ↗MalfunctionJan 11, 2018Crack
IT WAS REPORTED THAT THE CATHETER WAS INSERTED ON (B)(6) 2017. IT WAS ALSO REPORTED THAT THERE WAS A CRACKING OF THE CATHETER LUMEN AND THAT "THE CATHETER CONTAINED SOME LACTATE(D) RINGER." THEY WERE FORCED TO STOP THE PERFUSION AND REMOVE THE CATHETER THE NEXT DAY.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7182950 ↗MalfunctionNov 17, 2017Crack
IT WAS REPORTED BY THE SALES REP THAT THE PATIENT WAS SEEN IN THE HOSPITAL, WHILE AT THE FACILITY THE PATIENTS PORT WAS FLUSHED WITH SALINE AND A CRACK WAS NOTED NEAR THE CUFF AND FILLED UP WITH SALINE AT THE TUNNEL SITE. NO REPORTED PATIENT INJURY.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7043295 ↗MalfunctionOct 5, 2017Break; Detachment Of Device Component; Occlusion Within Device
PER MEDWATCH- REPORT STATED THAT GROSHONG CATHETER WAS OCCLUDED DURING A PLATELET INFUSION A WEEK AFTER PLACEMENT, THEY DISCONNECTED THE LINE AND FLUSHED- THE RED LUMEN AND PORT BROKE OFF. THEY REPAIRED AND FLUSHED WITH GOOD BLOOD RETURN. NO PATIENT INJURY REPORTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6917485 ↗MalfunctionSep 14, 2017Detachment Of Device Component
IT WAS REPORTED BY THE FACILITY, VIA MEDWATCH, THAT THE PATIENT HAD A RIGHT GROSHONG PLACEMENT AND THEY NOTICED 4 DAYS LATER THAT THE RED PART OF THE LUMEN BECAME DISCONNECTED FROM THE GROSHONG CATHETER. IT WAS NOTED THAT IT WAS JUST FOUND "UNDONE" FROM THE CATHETER WHILE CHEMO WAS INFUSING.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6866764 ↗MalfunctionSep 14, 2017Hole In Material; Leak/Splash
IT WAS REPORTED BY THE FACILITY, VIA MEDWATCH, THAT THE PATIENT NOTIFIED THE RN THAT THE WHITE LUMEN OF THE CATHETER WAS LEAKING. THEY STATED THERE WAS A VISIBLE HOLE IN THE LUMEN, CHEMO BLINCYTO INFUSING RATE 10 ML/HOUR. NO HARM TO THE PATIENT WAS REPORTED AND A CATHETER REPAIR WAS SUCCESSFULLY DONE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6866734 ↗MalfunctionSep 14, 2017Break; Fluid/Blood Leak
IT WAS REPORTED BY THE FACILITY, VIA MEDWATCH, THAT THIS IS THE SECOND INCIDENT THAT THE GROSHONG FAILED ON THE SAME DAY. IT WAS REPORTED TO BE IRREPARABLE. THEY STATED THAT THE PATIENT WAS FOUND TO BE WET IN BED, THE GROSHONG CATHETER WAS "BROKEN" AND IVF WAS LEAKING ON TO THE BED AND FLOOR. THE LUMEN WAS REPAIRED AND ALTEPLASE WAS ADMINISTERED TO THE WHITE LUMEN TO RESOLVE THE CLOT.
Patient problems: Chemical Exposure
MAUDE report 6866715 ↗MalfunctionSep 14, 2017Fluid/Blood Leak
IT WAS REPORTED BY THE FACILITY, VIA MEDWATCH, THAT THE PATIENT CALLED THE RN TO THE ROOM TO REPORT THE RED LUMEN ON THE GROSHONG CATHETER WAS LEAKING IV FLUIDS. IT WAS REPORTED THAT THE LUMEN HAD BEEN REPAIRED PRIOR TO THIS INCIDENT. THE RN FLUSHED THE LUMEN AND IVF WAS SQUIRTING AT THE END OF THE WHITE CUFF OF THE CATHETER. A NEW RED LUMEN WAS INSERTED AND CAPPED, THE LUMEN WAS COVERED WITH TAPE, INDICATING NOT TO USE. BLOOD RETURN WAS NOTED IN THE WHITE LUMEN, NO LEAK NOTED DURING SALINE FLUSH.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6866678 ↗MalfunctionSep 1, 2017Fluid/Blood Leak; Hole In Material
IT WAS REPORTED BY THE FACILITY, VIA THE SALES REP, THAT THE WHITE LUMEN OF THE CATHETER WAS LEAKING, IT WAS REMOVED AND IT WAS NOTED THAT THERE WAS A HOLE. THE LINE WAS REPAIRED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6839102 ↗MalfunctionSep 1, 2017Break; Detachment Of Device Component
IT WAS REPORTED BY THE FACILITY, VIA THE SALES REP, THAT WHEN THE LINE WAS UNHOOKED, THE LINE TO FLUSH THE RED LUMEN BROKE OFF.
Patient problems: No Information
MAUDE report 6839016 ↗
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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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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