Angiodynamics Inc. (Navilyst Medical Inc.) recalls
Every recall we track for Angiodynamics Inc. (Navilyst Medical Inc.) — 56 in all, from 2017–2021 — plus the complaints and injury reports the public filed about them. 1 is rated “stop using now”.
Recalls per year, by danger level
Recalls from Angiodynamics Inc. (Navilyst Medical Inc.) peaked in 2018 (42); 56 since 2017. 2% rated “stop using now”.
All FDA recall records for Angiodynamics Inc. (Navilyst Medical Inc.) since 2017, counted by recall date (one bar per calendar year; 2026 is partial). Danger level is GovInfoNow’s plain-language rating; “not yet rated” records are still being written up.
| Year | Stop using now | Use caution | Lower risk | Not yet rated | Total |
|---|---|---|---|---|---|
| 2017 | 0 | 0 | 1 | 0 | 1 |
| 2018 | 1 | 0 | 39 | 2 | 42 |
| 2019 | 0 | 2 | 9 | 0 | 11 |
| 2020 | 0 | 0 | 0 | 0 | 0 |
| 2021 | 0 | 0 | 2 | 0 | 2 |
| 2022 | 0 | 0 | 0 | 0 | 0 |
| 2023 | 0 | 0 | 0 | 0 | 0 |
| 2024 | 0 | 0 | 0 | 0 | 0 |
| 2025 | 0 | 0 | 0 | 0 | 0 |
| 2026 (to date) | 0 | 0 | 0 | 0 | 0 |
What to do if you have a recalled Angiodynamics Inc. (Navilyst Medical Inc.) product
- Match the model, catalog or lot number on your device to the recall.
- Ask the prescribing clinician or supplier what to do — many device recalls are corrections, not removals.
- Report problems to FDA MedWatch.
All Angiodynamics Inc. (Navilyst Medical Inc.) recalls
9 shown- Lower riskMedical device
Angiodynamics Inc. (Navilyst Medical Inc.) recalls AngioDynamics Safe Sheath Ultralite - Vascular Introducer/Catheter Introducer Catalogue #: VI10 - Product Usage: For
Angiodynamics recalls specific batch of Safe Sheath Ultralite vascular introducers due to potential sterility compromise. Affected units have Catalogue # VI10 and Lot # DP-11759. Contact for remedy.
AngiodynamicsFeb 22, 2021 - Lower riskMedical device
Angiodynamics Inc. (Navilyst Medical Inc.) recalls Starburst Talon Semi-Flex Electrosurgical Device, Part Number H7877001028451 incorrectly labelled as Starburst MRI
Angiodynamics recalls Starburst Talon Semi-Flex Electrosurgical Devices incorrectly labeled as Starburst MRI. This labeling error may cause procedural delays for end users.
AngiodynamicsOct 2, 2019 - Lower riskMedical device
Angiodynamics Inc. (Navilyst Medical Inc.) recalls BIOFLO 8F SINGLE TITANIUM NON- FILLED; VALVED, UPN H965440250, Cat. No. 44-025 - Product Usage: Long-term access to the
Angiodynamics recalls BIOFLO 8F titanium ports due to snap lock connector issues that may delay implantation procedures. Affected units have specific model numbers and were sold for long-term IV access.
AngiodynamicsSep 18, 2019 - Lower riskMedical device
Angiodynamics Inc. (Navilyst Medical Inc.) recalls AngioDynamics Solero Microwave Tissue Ablation (MTA) System: Solero Generator PG (1) Catalog Number:12740000 UPN:
Angiodynamics recalls Solero Generator PG units with specific serial numbers to reduce risk of procedure delays. Updated software and manual instructions help ensure safe use during medical procedures.
AngiodynamicsApr 17, 2019 - Lower riskMedical device
Angiodynamics Inc. (Navilyst Medical Inc.) recalls Xcela Power Injectable PICC with PASV (XCELA PASV 4F SL 55CM Catheter Kit CE PG), Cat no. 55-711
Angiodynamics recalls Xcela Power PICC kits with incorrect expiration dates that could lead to use beyond validated shelf life. Affected kits may need replacement to ensure safety.
AngiodynamicsOct 16, 2018 - Lower riskMedical device
Angiodynamics Inc. (Navilyst Medical Inc.) recalls BioFlo Port with ENDEXO and PASV Technology-AngioDynamics BIOFLO 8F SINGLE PLASTIC NON-FILLED; VALVED PG UPN:
Angiodynamics recalls BioFlo 8F ports with incorrect sterile port assembly. This could lead to infection or other complications during medical use. Affected units include specific lot numbers and catalog codes.
AngiodynamicsJul 24, 2018 - Lower riskMedical device
Angiodynamics Inc. (Navilyst Medical Inc.) recalls CAN 5F SINGLE XCELA PICC, Catalog Number 60M701531
Angiodynamics recalls CAN 5F SINGLE XCE:LA PICC kits with potential bacterial endotoxins. Affected units have specific catalog and lot numbers. Consumers should contact for details.
AngiodynamicsMay 10, 2018 - Lower riskMedical device
Angiodynamics Inc. (Navilyst Medical Inc.) recalls Fluid Management Convenience Kits (Angioplasty Kits) intended to be used in Fluid Management and/or Invasive Pressure
Angiodynamics recalls fluid management kits with specific lot numbers due to assembly issues causing minor procedure delays. Affected kits may not function properly during medical procedures.
AngiodynamicsJan 18, 2018 - Lower riskMedical device
Angiodynamics Inc. (Navilyst Medical Inc.) recalls Xcela PICC with PASV Valve Technology/Kit 5 F-55cm; (Maximum Flow Rate 3.5 mL/Sec)-indicated for short or long-term
Angiodynamics recalls Xcela PICC with PASV Valve Kit 5F-55cm due to mislabeling as 5F when it's actually 4F. This could lead to incorrect use in medical procedures.
AngiodynamicsOct 17, 2017
Angiodynamics Inc. (Navilyst Medical Inc.) recall questions
How many recalls has Angiodynamics Inc. (Navilyst Medical Inc.) had?
56 recalls from Angiodynamics Inc. (Navilyst Medical Inc.) are on record with U.S. safety agencies, from 2017–2021.
What is the most recent Angiodynamics Inc. (Navilyst Medical Inc.) recall?
Angiodynamics Inc. (Navilyst Medical Inc.) recalls AngioDynamics Safe Sheath Ultralite - Vascular Introducer/Catheter Introducer Catalogue #: VI10 - Product Usage: For, dated Feb 22, 2021. Every Angiodynamics Inc. (Navilyst Medical Inc.) recall is listed on this page, newest first.
What should I do if I have a recalled Angiodynamics Inc. (Navilyst Medical Inc.) product?
Match the model, catalog or lot number on your device to the recall. Ask the prescribing clinician or supplier what to do — many device recalls are corrections, not removals. Report problems to FDA MedWatch.
How do I get alerts for new Angiodynamics Inc. (Navilyst Medical Inc.) recalls?
Sign up for free email alerts on GovInfoNow — we check official CPSC, FDA, USDA and NHTSA data every day and email you only when a recall matches what you follow.