Groshong 6626954Recalls & reported problems
Bard Access Systems, Inc. · Groshong 9.5F Dual-Lumen CV Catheter Peel-Apart Introducer Kit with SureCuff Tissue Ingrowth Cuff Intermediate Kit (Dual-Lumen) · Class 2 · Implant
All models of Groshong (12)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00801741041563), received between Sep 28, 2017 and Aug 8, 2025 — classified as 4 malfunctions.
The most frequently reported specific device problem is “Device Dislodged or Dislocated” (2 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
- Device Dislodged or Dislocated2
- Tear, Rip or Hole in Device Packaging2
- Fluid/Blood Leak1
- Material Integrity Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- No Code Available1
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 8, 2025Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging
IT WAS REPORTED THAT PRIOR TO A CHRONIC CATHETER PLACEMENT PROCEDURE USING A GROSHONG D/L CATHETERS, RECEIVED PACKAGE AND IT WAS CUT. THERE WAS NO PATIENT CONTACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22747160 ↗MalfunctionAug 8, 2025Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging
A PATIENT WAS PREPPED FOR A CHRONIC CATHETER PLACEMENT PROCEDURE USING DUAL-LUMEN CV CATHETER. IT WAS REPORTED THAT PRIOR TO THE PLACEMENT PROCEDURE, THE PACKAGE WAS ALLEGEDLY FOUND TO BE CUT. THERE WAS NO PATIENT CONTACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22746583 ↗MalfunctionOct 24, 2017Fluid/Blood Leak; Device Dislodged or Dislocated
THE PATIENT REPORTED THAT ON (B)(6) 2017 SHE HAD A GROSHONG CVC THAT BECAME DISLODGED WITHIN 2 WEEKS OF PLACEMENT AND THE TPN SHE WAS RECEIVING LEAKED OUT. PATIENT STATES SHE WAS HOSPITALIZED TO REPLACE DEVICE AS WELL AS RECEIVE IV ANTIBIOTICS TO PREVENT INFECTION.
Patient problems: No Code Available
MAUDE report 6974788 ↗MalfunctionSep 28, 2017Device Dislodged or Dislocated; Material Integrity Problem
IT WAS REPORTED THAT THE CATHETER PLASTIC SOFTENED IN SITU WHICH CAUSED IT TO DISLODGE. NO PATIENT INJURY WAS REPORTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6900557 ↗
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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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