VYGON 1261.203ARecalls & reported problems
Vygon Corporation · PREMICATH 28 G (1 FR) 20 CM CATHETER WITH STYLET AND SPLITTING NEEDLE · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00849884002270), received between Sep 8, 2023 and Sep 8, 2023 — classified as 1 malfunction.
The most frequently reported specific device problem is “Mechanical Jam” (1 report).
1 other recall cover devices cleared under the same FDA submission (K041468); they may or may not involve this specific model.
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.
Most reported problems
Device problems
- Mechanical Jam1
Patient problems
- Insufficient Information1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 8, 2023Mechanical Jam; Mechanical Jam
THE STYLET GOT STUCK IN THE CATHETER WHEN TRYING TO REMOVE THE STYLET. THE STYLET BROKE OFF AND THE ENTIRE PICC HAD TO BE REMOVED.
Patient problems: Insufficient Information
MAUDE report 17713062 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K041468. One submission often covers many models, so check the product and lot details in each record.
- Z-0090-06 · Jun 27, 2005 · TerminatedPremicath 28G PICC Catheter
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 Catheter 3275118Bard Access Systems, Inc. · Catheter,intravascular,therapeutic,long-term greater than 30 days272 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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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