Occluder, Catheter Tip
Cardiovascular · 21 CFR 870.1370
Recent MDR events
153 adverse event reports on file
- PRUITT IRRIGATION OCCLUSION CATHETERApr 15, 2025MalfunctionLemaitre Vascular, Inc.1220948-2025-00065
- PRUITT IRRIGATION OCCLUSION CATHETERJul 20, 2023MalfunctionLemaitre Vascular, Inc.1220948-2023-00120
- PRUITT IRRIGATION OCCLUSION CATHETERApr 14, 2023MalfunctionLemaitre Vascular, Inc.1220948-2023-00053
- MICRO-INTRODUCER KITSApr 3, 2023MalfunctionAngiodynamics1319211-2023-00017
- MICRO-INTRODUCER KITSMar 30, 2023MalfunctionAngiodynamics1319211-2023-00014
- PRUITT AORTIC OCCLUSION CATHETERAug 5, 2022MalfunctionLemaitre Vascular, Inc.1220948-2022-00070
- MICRO-INTRODUCER KITSJun 7, 2022MalfunctionAngiodynamics1319211-2022-00029
- MICRO-INTRODUCER KITSFeb 10, 2022MalfunctionAngiodynamics1319211-2022-00008
- MICRO-INTRODUCER KITSFeb 10, 2022MalfunctionAngiodynamics1319211-2022-00006
- MICRO-INTRODUCER KITSFeb 10, 2022MalfunctionAngiodynamics1319211-2022-00007
Event type breakdown
Recalls
4 recall events for this product code
- LeMaitre Vascular, Inc.Open, ClassifiedMay 12, 2025
Pruitt Irrigation Occlusion Catheter. Catalog Numbers: 2102-09, E2102-09.
During internal product testing, it was observed that some packages to have incomplete seals (sterile barrier).
Z-1752-2025 · View FDA record ↗ - Medtronic VascularTerminatedNov 15, 2013
Zinger Stainless Steel Workhorse Guidewire; Models: ZNGRLS180HJ, ZNGRLS180HS, ZNGRMS180HJ, ZNGRMS180HS, ZNGRMS180S, ZNGRS180HJ, ZNGRS180HS, ZNGRS180S
Potential for PTFE (polytetrafluroethylene) coating to delaminate and detach from Guidewire.
Z-0262-2014 · View FDA record ↗ - Medtronic VascularTerminatedNov 15, 2013
ZINGER Steerable Guidewire; Models: LVZRLS180J, LVZRLS180S, LVZRMS180J, LVZRMS180S, LVZRXT180J, LVZRXT180S
Potential for PTFE (polytetrafluroethylene) coating to delaminate and detach from Guidewire.
Z-0268-2014 · View FDA record ↗ - LeMaitre Vascular, Inc.TerminatedNov 30, 2005
Product is a Pruitt Aortic Occlusion Catheter contained in a molded tray. The product is labeled in part: ''***LeMaitre VASCULAR***Distributed By:LeMaitre Vas
LeMaitre Vascular is recalling certain lots of its Pruitt Aortic Occlusion Catheters due to a packaging defect which could compromise product sterility.
Z-0219-06 · View FDA record ↗
Registered firms
9 firms currently registered for this product code
510(k) clearances
12 clearances for this product code
- Arterial Vascular Engineering, Inc.Mar 11, 1999
K983927 · GT1 FLOPPY, GT1 HI-PER FLEX, GT1 LIGHT SUPPORT
- Micro Interventional Systems, Inc.Feb 8, 1995
K945963 · THE OMNIGUIDE GUIDING CATHETER WITH BALLOON
- Cathlab Corp.Jun 24, 1991
K910916 · CATHLAB SILICONE OCCLUSION BALLOON CATHETER
- Applied Vascular Devices, Inc.May 29, 1991
K910339 · AVD INTIMAX OCCLUSION CATHETER
- Dlp, Inc.May 26, 1988
K880860 · CORONARY OSTIUM OCCLUDER, CATALOG CODE 32015
- Ideas For Medicine, Inc.May 25, 1988
K880231 · MODIFIED PRUITT IRRIGATION & OCCLUSION CATHETER
- Ideas For Medicine, Inc.Oct 30, 1987
K872090 · THE ROBICSEK - PRUITT AORTIC BALLOON OCCLUSION KIT
- Bd Becton Dickinson Vacutainer Systems PreanalyticSep 15, 1987
K872790 · PERFUSION CATHETER