Poly Per-Q-Cath Catheter with Sherlock Tip Location System (TLS) Stylet 9254108Recalls & reported problems
Bard Access Systems, Inc. · Poly Per-Q-Cath Catheter with Sherlock Tip Location System (TLS) Stylet 4F Full Tray · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00801741035623), received between Sep 19, 2024 and Oct 14, 2024 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Material Frayed” (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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Material Frayed1
Patient problems
- Foreign Body In Patient2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 14, 2024Material Frayed; Material Frayed
IT WAS REPORTED BY MEDWATCH THAT THE PATIENT UNDERWENT A SUCCESSFUL PICC PLACEMENT. FOLLOW-UP IMAGING COMPLETED NOTED A 1.4 CM RETAINED PIECE OF GUIDEWIRE. NO OTHER INFORMATION WAS PROVIDED.
Patient problems: Foreign Body In Patient
MAUDE report 20444844 ↗MalfunctionSep 19, 2024
ON [REDACTED], THE PATIENT UNDERWENT A SUCCESSFUL PICC PLACEMENT. FOLLOW-UP IMAGING COMPLETED ON [REDACTED] NOTED A 1.4 CM RETAINED PIECE OF GUIDEWIRE.
Patient problems: Foreign Body In Patient
MAUDE report 20255995 ↗
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- Groshong® Catheter 7717405Bard Access Systems, Inc. · Catheter,intravascular,therapeutic,long-term greater than 30 days279 reports
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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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