VYGON CLG-2034Recalls & reported problems
Vygon Corporation · 10" LIFEGUARD SAFETY INFUSION SET WITH 20 GA. X .75" HUBER NEEDLE · Class 2
- 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 08498840006283), received between Dec 6, 2019 and Dec 6, 2019 — classified as 1 malfunction.
The most frequently reported specific device problem is “Break” (1 report).
3 other recalls cover devices cleared under the same FDA submission (K013871); 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. How this data works · Data updated Oct 13, 2026.
Most reported problems
Device problems
- Break1
- Detachment of Device or Device Component1
Patient problems
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 6, 2019Break; Detachment of Device or Device Component
WHEN REMOVING NEEDLE FROM PORT, THE SAFETY RETRACTION PIECE ON HUBER NEEDLE BROKE OFF. NEAR MISS FOR NEEDLE STICK. FDA SAFETY REPORT ID # (B)(4).
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9437683 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K013871. One submission often covers many models, so check the product and lot details in each record.
- Z-0679-2018 · Jul 24, 2017 · Terminated20Ga x .75 LifeGuard Huber Needle with Y-site. Product Code: CLGY-2034.
- Z-0914-2013 · Jan 21, 2013 · TerminatedLifeguard Infusion Set with Smartsite, 20Ga, 1, CLGY-2010 Huber type needle set used for the infusion of medical fluids into implantable ports.
- Z-1327-2011 · Nov 16, 2010 · TerminatedChurchill Medical Systems LifeGuard Non-Coring Huber Needle, Lifeguard Non-Coring Safety Infusion Set 22GA, 3/4"; Item # CLG-2234 The Lifeguard
Other Set, administration, intravascular devices
- Autosoft XC 1001680Unomedical A/S · Set, Administration, Intravascular1 death16,105 reports
- Autosoft90™ 1002817Unomedical A/S · Set, Administration, Intravascular1 recall11,907 reports
- Minimed™ Quick-set™ MMT-399AUnomedical A/S · Set, Administration, Intravascular9 deaths8,669 reports
- Medtronic Extended MMT-431AUnomedical A/S · Set, Administration, Intravascular3 deaths8,574 reports
- MiniMed™ Mio™ Advance MMT-242AUnomedical A/S · Set, Administration, Intravascular15 deaths8,164 reports
- CADD 21-7302-24Icu Medical, Inc. · Set, administration, intravascular4 recalls1 death4,657 reports
- Autosoft XC 1001681Unomedical A/S · Set, Administration, Intravascular1 death4,216 reports
- Minimed™ Quick-set™ MMT-397AUnomedical A/S · Set, Administration, Intravascular19 deaths4,134 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.