Catheter, Femoral
Gastroenterology, Urology · 21 CFR 876.5540
Recent MDR events
42 adverse event reports on file
- THIRD PARTY CONMED VCAREAug 12, 2023InjuryConmed CorporationMW5136897
- VOLUMEVIEW FEMORAL CATHETER KITJul 7, 2023MalfunctionEdwards Lifesciences, Pr2015691-2023-14406
- UTERINE CANNULAE W/2 CONES LGTH 330MMMar 18, 2021InjuryAesculap Ag2916714-2021-00039
- UTERINE CANNULAE W/2 CONES LGTH 330MMMar 18, 2021InjuryAesculap Ag9610612-2021-00187
- CATHETER, FEMORALJul 21, 2020Injury10303187
- ICY FEMORAL CATHETER 3893Jan 25, 2013MalfunctionZoll Circulation, Inc.3003793491-2013-00035
- *Sep 27, 2012Malfunction2800993
- QUINTON CATHETERFeb 7, 2008InjuryBaxter Healthcare Corp.MW5005347
- MEDCOMP PD CATHMay 14, 2007MalfunctionMps Medical Product Service GmbhMW1042878
- RESEARCH MEDICAL INCSep 21, 2006Other*MW1040478
Event type breakdown
Recalls
7 recall events for this product code
- Cook Inc.TerminatedAug 22, 2016
FluoroSet Radiographic Tubal Assessment Set
Increase in reports of polymer degradation of the catheter tip, resulting in tip fracture and/or separation. degradation could include loss of device function, separation of a device segment leading to medical intervention, or complications resulting from a separated segment. Such complications include device fragments in the vascular system, genitourinary system, or other soft tissues. Fragments within the vascular system could result in embolization to the heart or lungs, or occluding blood flow to end organs.
Z-2615-2016 · View FDA record ↗ - ConMed CorporationTerminatedOct 28, 2008
VCARE (Vaginal-Cervical-Ahluwalia's-Retractor-Elevator) STANDARD, Uterine Manipulator, REF 60-6085-000. Made in USA, CONMED CORPORATION, UTICA, NEW YORK USA 13
The firm received several complaints sighting detachment of the balloon at the distal end of the shaft. It was also noted that the incidence of the forward cup slipping off the shaft and being retained in the vaginal canal had increased.
Z-0175-2009 · View FDA record ↗ - ConMed CorporationTerminatedOct 28, 2008
VCARE (Vaginal-Cervical-Ahluwalia's-Retractor-Elevator) SMALL, Uterine Manipulator, REF 60-6085-001. Made in USA, CONMED CORPORATION, UTICA, NEW YORK USA 13502.
The firm received several complaints sighting detachment of the balloon at the distal end of the shaft. It was also noted that the incidence of the forward cup slipping off the shaft and being retained in the vaginal canal had increased.
Z-0176-2009 · View FDA record ↗ - ConMed CorporationTerminatedOct 28, 2008
VCARE (Vaginal-Cervical-Ahluwalia's-Retractor-Elevator) LARGE, Uterine Manipulator, REF 60-6085-002. Made in USA, CONMED CORPORATION, UTICA, NEW YORK USA 13502
The firm received several complaints sighting detachment of the balloon at the distal end of the shaft. It was also noted that the incidence of the forward cup slipping off the shaft and being retained in the vaginal canal had increased.
Z-0177-2009 · View FDA record ↗ - ConMed CorporationTerminatedOct 28, 2008
VCARE (Vaginal-Cervical-Ahluwalia's-Retractor-Elevator) STANDARD, Uterine Manipulator, REF 60-6085-100. Made in USA, CONMED CORPORATION, UTICA, NEW YORK USA 13
The firm received several complaints sighting detachment of the balloon at the distal end of the shaft. It was also noted that the incidence of the forward cup slipping off the shaft and being retained in the vaginal canal had increased.
Z-0178-2009 · View FDA record ↗ - ConMed CorporationTerminatedOct 28, 2008
VCARE (Vaginal-Cervical-Ahluwalia's-Retractor-Elevator) SMALL, Uterine Manipulator, REF 60-6085-101. Made in USA, CONMED CORPORATION, UTICA, NEW YORK USA 13502
The firm received several complaints sighting detachment of the balloon at the distal end of the shaft. It was also noted that the incidence of the forward cup slipping off the shaft and being retained in the vaginal canal had increased.
Z-0179-2009 · View FDA record ↗ - ConMed CorporationTerminatedOct 28, 2008
VCARE (Vaginal-Cervical-Ahluwalia's-Retractor-Elevator) LARGE, Uterine Manipulator, REF 60-6085-102. Made in USA, CONMED CORPORATION, UTICA, NEW YORK USA 13502
The firm received several complaints sighting detachment of the balloon at the distal end of the shaft. It was also noted that the incidence of the forward cup slipping off the shaft and being retained in the vaginal canal had increased.
Z-0180-2009 · View FDA record ↗
Registered firms
11 firms currently registered for this product code
510(k) clearances
16 clearances for this product code
- Medron, Inc.Oct 21, 1997
K971897 · CONTINUOUS ARTERIOVENOUS HEMOFILTRATION CATHETER 10 FR (CAVH)
- Akcess Medical Products, Inc.Apr 23, 1992
K914936 · CONTINUOUS ARTERIOVENOUS HEMOFILTRATION CATH SET
- Akcess Medical Products, Inc.Mar 27, 1992
K915215 · CONTINUOUS ARTERIOVENOUS HEMOFILTRATION CATH. KITS
- Akcess Medical Products, Inc.Apr 7, 1989
K891764 · FC-101 FEMORAL CATHETER GUIDE WIRE
- Akcess Medical Products, Inc.Apr 7, 1989
K891763 · FC-100 FEMORAL CATHETER
- Vas-Cath, Inc.Apr 5, 1989
K890717 · MODIFICATION HEMOFILTRATION CATHETER HF-100
- Medsurg Industries, Inc.Jul 25, 1988
K880775 · CONTINUOUS ARTERIAL/VENOUS HEMOFILTRATION TRAY
- Vas-Cath, Inc.Jul 13, 1988
K882466 · VAS-CATH PEDIATRIC HEMOFILTRATION CATHETER