FDA Device Intelligence
HomeBard Access Systems, Inc. › PowerPort ClearVUE, ChronoFlex

PowerPort ClearVUE, ChronoFlex

Bard Access Systems, Inc. · Model 1618380 · UDI-DI 00801741136740

LJT Prescription
10
510(k) clearances
22,474
Adverse events (405 deaths)
141
Recalls
59
Facilities

Description

PowerPort ClearVUE Slim, 8F ChronoFlex Catheter and Suture Plugs, Intermediate NAUTILUS DELTA Kit

Recalls

DateFirmReason
2026-04-21ARROW INTERNATIONAL, LLCLidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and sets. The supplier was found to have quality issues and limited repo
2025-07-21B.Braun Medical S.A.S.The potential for minor injury such as damage to the vessel and/or tearing of the vessel wall.
2025-02-13Smiths Medical ASD, Inc.The plastic port housing and port reservoir of the ProPort Plastic Implantable Ports may separate because of a manufacturing defect.
2025-02-13Smiths Medical ASD, Inc.The plastic port housing and port reservoir of the ProPort Plastic Implantable Ports may separate because of a manufacturing defect.
2025-02-13Smiths Medical ASD, Inc.The plastic port housing and port reservoir of the ProPort Plastic Implantable Ports may separate because of a manufacturing defect.
2025-02-13Smiths Medical ASD, Inc.The plastic port housing and port reservoir of the ProPort Plastic Implantable Ports may separate because of a manufacturing defect.
2025-02-13Smiths Medical ASD, Inc.The plastic port housing and port reservoir of the ProPort Plastic Implantable Ports may separate because of a manufacturing defect.
2025-02-13Smiths Medical ASD, Inc.The plastic port housing and port reservoir of the ProPort Plastic Implantable Ports may separate because of a manufacturing defect.
2025-02-13Smiths Medical ASD, Inc.The plastic port housing and port reservoir of the ProPort Plastic Implantable Ports may separate because of a manufacturing defect.
2025-02-13Smiths Medical ASD, Inc.The plastic port housing and port reservoir of the ProPort Plastic Implantable Ports may separate because of a manufacturing defect.

Query this across every FDA database — by API.

Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.

Get your free API keyRead the docs
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.