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enableCV OptiSite™ Arterial Perfusion Cannula

ENABLECV INC. · Model OPTI16 · UDI-DI 00840479401034

DQR Prescription
1
510(k) clearances
654
Adverse events (23 deaths)
26
Recalls
21
Facilities

Description

OptiSite™ Arterial Perfusion Cannula - OPTI16

Recalls

DateFirmReason
2025-05-14Edwards Lifesciences, LLCdue to complaints received for 3mm to 4mm section wire exposed/protruding from the outside of the cannula body.
2025-05-14Edwards Lifesciences, LLCdue to complaints received for 3mm to 4mm section wire exposed/protruding from the outside of the cannula body.
2025-05-14Edwards Lifesciences, LLCdue to complaints received for 3mm to 4mm section wire exposed/protruding from the outside of the cannula body.
2025-05-14Edwards Lifesciences, LLCdue to complaints received for 3mm to 4mm section wire exposed/protruding from the outside of the cannula body.
2025-05-14Edwards Lifesciences, LLCdue to complaints received for 3mm to 4mm section wire exposed/protruding from the outside of the cannula body.
2025-05-14Edwards Lifesciences, LLCdue to complaints received for 3mm to 4mm section wire exposed/protruding from the outside of the cannula body.
2020-10-14Angiodynamics, Inc.5F Micro-Introducer Kits may not contain the correct device, packaged with a 4F Sheath/Dilator component
2018-03-07SPS Sterilization, IncThe expiration date on the device labeling exceeds its actual validated shelf life because the sterilization process used does not have adequate support for the extended shelf life
2013-04-30Angiodynamics, Inc.AngioDynamics Inc., is recalling Micro Introducer Kits and VenaCure EVLT NeverTouch Procedure Kits, because the potential exists that the micro Introducer (sheath/dilator) packaged
2004-03-11Guidant Corp-Cpi DivisionThe 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

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.