Groshong 7712800Recalls & reported problems
Bard Access Systems, Inc. · Groshong Replacement Connector for Groshong 8F Single Lumen CV Catheter · Class 2
All models of Groshong (12)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00801741087028), received between Apr 10, 2018 and Nov 10, 2023 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Break” (1 report).
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
- Break1
- Detachment of Device or Device Component1
- Fluid/Blood Leak1
- Manufacturing, Packaging or Shipping Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
- No Consequences Or Impact To Patient1
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 10, 2023Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT ONE YEAR, ELEVEN MONTHS, AND TWENTY-SEVEN DAYS POST A CHRONIC CATHETER PLACEMENT, THE FLUID ALLEGEDLY LEAKED IN THE CONNECTOR. REPORTEDLY, THE LEAK SEEMED TO BE CAME FROM THE CONNECTOR BECAUSE AFTER CHANGING IT, THE ISSUE WAS RESOLVED. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18110539 ↗MalfunctionJul 24, 2019Detachment of Device or Device Component; Detachment of Device or Device Component
THIS REPORT SUMMARIZES ONE (1) MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL 7712800 PORT AND CATHETER ACCESSORIES ALLEGEDLY EXPERIENCED A DETACHMENT OF DEVICE COMPONENT. THIS INFORMATION WAS RECEIVED FROM ONE SOURCE. THE MALFUNCTION INVOLVED A PATIENT WITH NO KNOWN IMPACT TO THE PATIENT. THE (B)(6) MALE PATIENT WAS (B)(6).
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8822596 ↗MalfunctionApr 10, 2018Break; Manufacturing, Packaging or Shipping Problem
IT WAS REPORTED THAT THE PHYSICIAN IS HAVING REPEATED BREAKS IN THE EXTERNAL HUB OF THE GROSHONG, THIS IS ALLEGEDLY HAPPENING AT LEAST ONCE A MONTH. THE PHYSICIAN STATES THAT IT IS HAPPENING WITH THE INITIAL DEVICE AND THE REPAIR KIT. HE STATED THAT IT HAS BEEN HAPPENING FOR YEARS AND HE THINKS IT IS A DESIGN FLAW. HE REPORTED THAT IT BREAKS A THE END EVERY TIME.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7419465 ↗
Other Catheter,intravascular,therapeutic,long-term greater than 30 days devices
- Groshong NXT ClearVue Catheter 7617405Bard Access Systems, Inc. · Catheter,intravascular,therapeutic,long-term greater than 30 days2 deaths1,708 reports
- Groshong NXT ClearVue Catheter 7655405Bard Access Systems, Inc. · Catheter,intravascular,therapeutic,long-term greater than 30 days2 deaths1,536 reports
- PowerPICC Catheter 3174118Bard Access Systems, Inc. · Catheter,intravascular,therapeutic,long-term greater than 30 days1 recall402 reports
- L-Cath™ S/L PICC S/L 26GA (1.9F) x 30cmArgon Medical Devices, Inc. · Catheter,Intravascular,Therapeutic,Long-Term Greater Than 30 Days2 recalls245 reports
- PowerPICC SOLO2 Catheter 1194108DBard Access Systems, Inc. · Catheter,intravascular,therapeutic,long-term greater than 30 days2 recalls216 reports
- Broviac 0600520Bard Access Systems, Inc. · Catheter,intravascular,therapeutic,long-term greater than 30 days1 recall265 reports
- Groshong® Catheter 7717405Bard Access Systems, Inc. · Catheter,intravascular,therapeutic,long-term greater than 30 days279 reports
- PowerPICC® Catheters 1174108DBard Access Systems, Inc. · Catheter,intravascular,therapeutic,long-term greater than 30 days1 recall222 reports
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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