Cannula, Catheter
Cardiovascular · 21 CFR 870.1300
Recent MDR events
654 adverse event reports on file
- OPTISITE ARTERIAL CANNULAJun 17, 2026MalfunctionEnablecv, Llc3031571797-2026-00013
- OPTISITE ARTERIAL CANNULAApr 22, 2026MalfunctionEnablecv, Llc3031571797-2026-00004
- CANNULA, CATHETERMar 26, 2026Malfunction24698235
- OPTISITE ARTERIAL CANNULAAug 12, 2025MalfunctionEdwards Lifesciences2015691-2025-06574
- OPTISITE ARTERIAL CANNULAMay 28, 2025MalfunctionEdwards Lifesciences2015691-2025-04218
- OPTISITE ARTERIAL CANNULAMay 1, 2025MalfunctionEdwards Lifesciences2015691-2025-03442
- OPTISITE ARTERIAL CANNULAMar 24, 2025MalfunctionEdwards Lifesciences2015691-2025-02219
- OPTISITE ARTERIAL PERFUSION CANNULAJan 15, 2025MalfunctionEdwards Lifesciences Llc21157835
- OPTISITE ARTERIAL CANNULAJan 6, 2025MalfunctionEdwards Lifesciences2015691-2025-00096
- PHENOMAug 29, 2024InjuryMicro Therapeutics, Inc. Dba Ev32029214-2024-01496
Event type breakdown
Recalls
26 recall events for this product code
- Edwards Lifesciences, LLCOpen, ClassifiedJul 10, 2025
Brand Name: Optisite Arterial Cannula
due to complaints received for 3mm to 4mm section wire exposed/protruding from the outside of the cannula body.
Z-2080-2025 · View FDA record ↗ - Edwards Lifesciences, LLCOpen, ClassifiedJul 10, 2025
Brand Name: Optisite Arterial Cannula
due to complaints received for 3mm to 4mm section wire exposed/protruding from the outside of the cannula body.
Z-2081-2025 · View FDA record ↗ - Edwards Lifesciences, LLCOpen, ClassifiedJul 10, 2025
Brand Name: FEM-FLEX II
due to complaints received for 3mm to 4mm section wire exposed/protruding from the outside of the cannula body.
Z-2082-2025 · View FDA record ↗ - Edwards Lifesciences, LLCOpen, ClassifiedJul 10, 2025
Brand Name: FEM-FLEX II
due to complaints received for 3mm to 4mm section wire exposed/protruding from the outside of the cannula body.
Z-2083-2025 · View FDA record ↗ - Edwards Lifesciences, LLCOpen, ClassifiedJul 10, 2025
Brand Name: FEM-FLEX II
due to complaints received for 3mm to 4mm section wire exposed/protruding from the outside of the cannula body.
Z-2084-2025 · View FDA record ↗ - Edwards Lifesciences, LLCOpen, ClassifiedJul 10, 2025
Brand Name: FEM-FLEXII
due to complaints received for 3mm to 4mm section wire exposed/protruding from the outside of the cannula body.
Z-2085-2025 · View FDA record ↗ - Angiodynamics, Inc.TerminatedMay 25, 2013
AngioDynamics Micro Introducer Kits under the following labeling:
AngioDynamics Inc., is recalling Micro Introducer Kits and VenaCure EVLT NeverTouch Procedure Kits, because the potential exists that the micro Introducer (sheath/dilator) packaged within the kit could be the incorrect French size.
Z-1405-2013 · View FDA record ↗ - Guidant Corp-Cpi DivisionTerminatedJul 20, 2004
Guidant EasyTrak 8 French Guiding Catheter, Inner Diameter .087'', 2.21 mm, Overall Length 54 cm, CS Wide Tip Shape, CS-W, REF 6705
The terminal hub component in a some of the catheters has an unintended abrupt transition between the entry port and the catheter lumen which can result in difficulty introducing or removing delivery system components during lead placement.
Z-0790-04 · View FDA record ↗ - Guidant Corp-Cpi DivisionTerminatedJul 20, 2004
Guidant EasyTrak 8 French Guiding Catheter, Inner Diameter .087'', 2.21 mm, Overall Length 44 cm, Coronary Sinus - Multi-Purpose Tip Shape, CS-MP, REF 6716
The terminal hub component in a some of the catheters has an unintended abrupt transition between the entry port and the catheter lumen which can result in difficulty introducing or removing delivery system components during lead placement.
Z-0791-04 · View FDA record ↗ - Guidant Corp-Cpi DivisionTerminatedJul 20, 2004
Guidant EasyTrak 8 French Guiding Catheter, Inner Diameter .087'', 2.21 mm, Overall Length 49 cm, Coronary Sinus - Multi-Purpose Tip Shape, CS-MP, REF 6717
The terminal hub component in a some of the catheters has an unintended abrupt transition between the entry port and the catheter lumen which can result in difficulty introducing or removing delivery system components during lead placement.
Z-0792-04 · View FDA record ↗
Registered firms
26 firms currently registered for this product code
Steril Verona Srl
Nogara Verona, IT
Sorin Group Italia S.r.l
MIRANDOLA Modena, IT
Jarit Gmbh
Rietheim-Weilheim Baden-Wurttemberg, DE
Biomerics
Salt Lake City, UT, US
Angiodynamics, Inc.
Queensbury, NY, US
St. Jude Medical, Cardiology Division, Inc.
Plymouth, MN, US
Qsa Surgical (pvt) Ltd.
SIALKOT Punjab, PK
Medron, Llc
SALT LAKE CITY, UT, US
Integra Lifesciences Corporation
Princeton, NJ, US
Ilg Medizintechnik Gmbh
DURCHHAUSEN Baden-Wurttemberg, DE
Benchmark Electronics, Inc.
WINONA, MN, US
Vygon S A
ECOUEN 95440 Val-d'Oise, FR
Enablecv, Llc
Midvale, UT, US
Angiodynamics, Inc.
Marlborough, MA, US
Ultimate Medical Products Ltd.
SHARJAH Ash Shariqah, AE
Vygon Verneuil
Verneuil En Halatte Oise, FR
Sterigenics U.s., Llc
Salt Lake City, UT, US
Argon Medical Devices, Inc.
WHEELING, IL, US
Oxiline Llc
Miami, FL, US
Midwest Sterilization Corp.
JACKSON, MO, US
Integra Lifesciences Production Corporation
Mansfield, MA, US
510(k) clearances
25 clearances for this product code
- Integra LifeSciences CorporationOct 28, 2013
K131446 · INTEGRA JARIT HEPARIN CANNULAS, INJECTORS, AND NEEDLES
- Edwards Lifesciences Research MedicalJan 31, 2008
K073559 · 18 FR. RMI ARTERIAL PERFUSION CANNULA II, 20 FR. RMI ARTERIAL PERFUSION CANNULA II
- AngioDynamics, Inc.Sep 12, 2005
K051655 · ANGIODYNAMICS, INC., MICRO ACCESS KITS
- Cardiacassist, Inc.May 23, 2003
K030398 · CARDIACASSIST TRANSSEPTAL CANNULA SET, MODEL 5132-6221
- Research Medical, Inc.Mar 26, 1996
K960098 · RMI INTERNAL MAMMARY ARTERY CANNULA
- Datascope Corp.Jan 16, 1991
K902674 · DATASCOPE ARTERIAL CANNULA W/ACCESS PORT
- Shiley, Inc.Mar 28, 1990
K894784 · MODIFIED SHILEY FEMORAL VENOUS CANNULA
- Research Medical, Inc.Sep 19, 1989
K894243 · RMI ARTERIAL PERFUSION CANNULA