Groshong 7726954Recalls & reported problems
Bard Access Systems, Inc. · Groshong 9.5F Dual-Lumen CV Catheter Peel-Apart Introducer with SureCuff Tissue Ingrowth Cuff Intermediate Kit · Class 2 · Implant
All models of Groshong (12)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 6
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00801741041587), received between May 26, 2016 and Sep 12, 2023 — classified as 2 injuries, 4 malfunctions.
The most frequently reported specific device problem is “Fracture” (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.
Most reported problems
Device problems
- Fracture2
- Break1
- Component Missing1
- Hole In Material1
- Material Fragmentation1
- Material Separation1
- Unintended Ejection1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- Injury1
- No Consequences Or Impact To Patient1
- No Information1
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 12, 2023Fracture; Material Separation; Component Missing; Fracture; Material Separation; Component Missing
IT WAS REPORTED THAT SOMETIME POST CHRONIC CATHETER PLACEMENT, THE CATHETER ALLEGEDLY HAD MISSING PIECES. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17727754 ↗MalfunctionOct 20, 2022Fracture; Fracture
IT WAS REPORTED THAT SOME TIME POST CATHETER PLACEMENT PROCEDURE, THE CATHETER ALLEGEDLY EXPLODED UPON POWER INFUSION. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15636911 ↗MalfunctionJun 8, 2017Break
IT WAS REPORTED BY THE PATIENT, VIA (B)(4) THAT SHE HAD TO HAVE HER GROSHONG CATHETER REPLACED ON (B)(6) 2017. SHE STATED THAT SHE HAD THE EXACT SAME TYPE OF CATHETER PLACED AFTER REMOVAL OF THE DAMAGED ONE, BUT THE SURGEON HAD TO INSERT IT THROUGH A NEW SITE. THE PATIENT REQUESTED A NEW ID CARD, WHICH (B)(4) SENT TO HER. NO OTHER INFORMATION WAS PROVIDE. NO HARM TO THE PATIENT WAS REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6624732 ↗InjuryMay 10, 2017Unintended Ejection
FACILITY REPORTED TO THE SALES REP THAT WHILE FLUSHING THE DEVICE THE HUB AND THE VALVE POPPED OUT. FACILITY HAS REPORTED PATIENT INJURY, ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Injury
MAUDE report 6556610 ↗MalfunctionJan 18, 2017Hole In Material
IT WAS REPORTED BY PHYSICIAN AT THE FACILITY THAT THE PICC HAD A HOLE THAT WAS FOUND DURING FLUSHING AS PART OF PROTOCOL AFTER IMPLANTATION; IT WAS REMOVED AND REPLACED. NO PATIENT HARM.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6261277 ↗InjuryMay 26, 2016Material Fragmentation
ON 05/06/2016- PER SALES REPRESENTATIVE USER FACILITY REPORTED THAT THEY WERE REMOVING A GROSHONG CATHETER FROM A PATIENT THAT WAS PLACED AT A DIFFERENT FACILITY. IT WAS STATED THAT AS THE DOCTOR WAS REMOVING THE CATHETER IT "SNAPPED". THE PATIENT HAD TO UNDERGO CUT DOWN SURGERY TO REMOVE THE REMAINING PORTION OF THE CATHETER.
Patient problems: No Information
MAUDE report 5682625 ↗
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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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