Angiodynamics Navilyst Medical recalls
Angiodynamics Navilyst Medical appears in 78 official U.S. recall notices indexed by RecallRadar, most recently on 2021-10-06.
Company names are normalized from agency data (legal suffixes removed), so related firms may appear under separate pages.
Recall summary
| Recall notices | 78 |
|---|---|
| Published | 2016-06-01 to 2021-10-06 |
| By agency | FDA Device (78) |
| By classification | Class II (78) |
| By status | terminated (78) |
| Distribution named in notices | AZ, CA, CO, CT, DC, FL, GA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, US, VA, WA, WI, WV |
Recalls
- Xcela PICC with PASV Valve Technology/Kit 5 F-55cm
FDA Device · Class II · 2021-10-06 · Angiodynamics Navilyst Medical
Reason: Mislabeled: The product is labeled as 5F (55cm; Maximum Flow Rate 3.5 mL/Sec) and the product is actually 4F (55cm; Maximum Flow Rate 3.5 mL/Sec). - AngioDynamics Safe Sheath Ultralite - Vascular Introducer/Catheter Introducer Catalogue #: VI10 - Product Usage: For the introduction of va…
FDA Device · Class II · 2021-04-28 · Angiodynamics Navilyst Medical
Reason: AngioDynamics, Inc. is recalling a specific batch of AngioDynamics Implantable Infusion Port kits and Valved introducers that may have potential for compromised sterility of the device. Only the specific product/lot of… - Smart Port CT-Implantable Port Catalogue #: CT96STSD-VI, CT96STSA-VI - Product Usage: indicated for any patient requiring repeated access o…
FDA Device · Class II · 2021-04-28 · Angiodynamics Navilyst Medical
Reason: AngioDynamics, Inc. is recalling a specific batch of AngioDynamics Implantable Infusion Port kits and Valved introducers that may have potential for compromised sterility of the device. Only the specific product/lot of… - XCELA, 8F SINGLE PLASTIC PORT FILLED, VALVED, UPN H965440400, Cat
FDA Device · Class II · 2019-11-27 · Angiodynamics Navilyst Medical
Reason: Snap lock connectors provided within implantable port kits may not meet dimensional specifications, and the catheter cannot be inserted into the snap lock connector prior to connection to the port chamber, resulting in… - BIOFLO 8F SINGLE PLASTIC FILLED
FDA Device · Class II · 2019-11-27 · Angiodynamics Navilyst Medical
Reason: Snap lock connectors provided within implantable port kits may not meet dimensional specifications, and the catheter cannot be inserted into the snap lock connector prior to connection to the port chamber, resulting in… - BIOFLO 8F SINGLE TITANIUM NON- FILLED
FDA Device · Class II · 2019-11-27 · Angiodynamics Navilyst Medical
Reason: Snap lock connectors provided within implantable port kits may not meet dimensional specifications, and the catheter cannot be inserted into the snap lock connector prior to connection to the port chamber, resulting in… - BIOFLO 8F SINGLE PLASTIC FILLED
FDA Device · Class II · 2019-11-27 · Angiodynamics Navilyst Medical
Reason: Snap lock connectors provided within implantable port kits may not meet dimensional specifications, and the catheter cannot be inserted into the snap lock connector prior to connection to the port chamber, resulting in… - BIOFLO 8F SINGLE PLASTIC NON-FILLED
FDA Device · Class II · 2019-11-27 · Angiodynamics Navilyst Medical
Reason: Snap lock connectors provided within implantable port kits may not meet dimensional specifications, and the catheter cannot be inserted into the snap lock connector prior to connection to the port chamber, resulting in… - Starburst Talon Semi-Flex Electrosurgical Device, Part Number H7877001028451 incorrectly labelled as Starburst MRI Semi-Flex Electrosurgica…
FDA Device · Class II · 2019-11-27 · Angiodynamics Navilyst Medical
Reason: The devices are not labelled correctly. End users impacted by this issue may experience a procedural delay. - AngioDynamics Solero Microwave Tissue Ablation (MTA) System: Solero Generator PG (1) Catalog Number:12740000 UPN: H78712740000 (2) Solero G…
FDA Device · Class II · 2019-06-12 · Angiodynamics Navilyst Medical
Reason: Updated Warning Statements in the Operator's Manual/Directions for Use and Software Updates to reduce the risk of potential patient harm due to a delay in performing a procedure - AngioDynamics Solero Microwave Tissue Ablation (MTA) System: (1)Solero Applicator 19cm PG Catalog Number: 700106002 UPN: H7877001060020 (2)…
FDA Device · Class II · 2019-06-12 · Angiodynamics Navilyst Medical
Reason: Updated Warning Statements in the Operator's Manual/Directions for Use and Software Updates to reduce the risk of potential patient harm due to a delay in performing a procedure - AngioDynamics Solero Microwave Tissue Ablation (MTA) System: (1) Solero Generator Refurbished PG Catalog Number: 12740000D UPN: H7871274000…
FDA Device · Class II · 2019-06-12 · Angiodynamics Navilyst Medical
Reason: Updated Warning Statements in the Operator's Manual/Directions for Use and Software Updates to reduce the risk of potential patient harm due to a delay in performing a procedure - AngioDynamics Solero Microwave Tissue Ablation (MTA) System: (1) Solero Applicator 14cm PG Catalog Number: 700106001 UPN:H7877001060010
FDA Device · Class II · 2019-06-12 · Angiodynamics Navilyst Medical
Reason: Updated Warning Statements in the Operator's Manual/Directions for Use and Software Updates to reduce the risk of potential patient harm due to a delay in performing a procedure - AngioDynamics Solero Microwave Tissue Ablation (MTA) System: (1)Solero Applicator 29cm PG Catalog Number:700106003 UPN: H7877001060030 (2)S…
FDA Device · Class II · 2019-06-12 · Angiodynamics Navilyst Medical
Reason: Updated Warning Statements in the Operator's Manual/Directions for Use and Software Updates to reduce the risk of potential patient harm due to a delay in performing a procedure - Xcela Power Injectable PICC with PASV (XCELA PASV 4F SL 55CM Catheter Kit CE PG), Cat no. 55-711
FDA Device · Class II · 2018-12-19 · Angiodynamics Navilyst Medical
Reason: Specific lots of Xcela Power Injectable and BioFlo PICCs are labelled with incorrect expiration dates. The labelled expiration date extends the shelf life of the product beyond the date supported by validation testing.… - BioFlo PICC with ENDEXO and PASV, ( RS 5F DL BIOFLO PASV - MEMORIAL HOSPITAL SYSTEM (LTP) PG) Cat. no. 60M183481
FDA Device · Class II · 2018-12-19 · Angiodynamics Navilyst Medical
Reason: specific lots of Xcela Power Injectable and BioFlo PICCs are labelled with incorrect expiration dates. The labelled expiration date extends the shelf life of the product beyond the date supported by validation testing.… - BioFlo Port with ENDEXO and PASV Technology-AngioDynamics BIOFLO 8F SINGLE PLASTIC NON-FILLED
FDA Device · Class II · 2018-10-17 · Angiodynamics Navilyst Medical
Reason: BioFlo Ports was partially manufactured with the incorrect sterile port assembly. The actual sterile port assembly used was, 8F SL Xcela Plus Titanium Valved Non-Filled, when it should have been, 8F SL BioFlo Plastic Va… - BioFlo Midline 5F DL-20cm MST-45 Kit w/ Two Nitinol Guidewires PG, Catalog Number 46-810
FDA Device · Class II · 2018-06-20 · Angiodynamics Navilyst Medical
Reason: A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens). - RS 5F DL BIOFLO PICC, Catalog Number 60M071831
FDA Device · Class II · 2018-06-20 · Angiodynamics Navilyst Medical
Reason: A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens). - RS 5F DL XPP KIT, Catalog Number 60M183104
FDA Device · Class II · 2018-06-20 · Angiodynamics Navilyst Medical
Reason: A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens). - BioFlo PICC (Valved) 5FDL-55cm Maximal Barrier Nursing Kit w/70cm Nitinol Wire PG, Catalog Number 75-038
FDA Device · Class II · 2018-06-20 · Angiodynamics Navilyst Medical
Reason: A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens). - RS 5F DL XPP, Catalog Number 60M030393
FDA Device · Class II · 2018-06-20 · Angiodynamics Navilyst Medical
Reason: A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens). - Xcela 5FDL-55cm Maximal Barrier Nursing Kit PG, Catalog Number 75-003
FDA Device · Class II · 2018-06-20 · Angiodynamics Navilyst Medical
Reason: A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens). - Bio-Stable 5F DL-55CM IR-145 Kit Non-Valved with Nitinol GW PG, Catalog Number 45-887
FDA Device · Class II · 2018-06-20 · Angiodynamics Navilyst Medical
Reason: A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens). - RS 5F DL BIOFLO PASV, Catalog Number 60M150373
FDA Device · Class II · 2018-06-20 · Angiodynamics Navilyst Medical
Reason: A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens). - CAN 5F SINGLE XCELA PICC, Catalog Number 60M701531
FDA Device · Class II · 2018-06-20 · Angiodynamics Navilyst Medical
Reason: A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens). - Bio-Stable 5F SL-55CM IR-145 Kit Valved with Nitinol GW PG, Catalog Number 45-882
FDA Device · Class II · 2018-06-20 · Angiodynamics Navilyst Medical
Reason: A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens). - RS 5F DL BIOFLO PASV, Catalog Number 60M183481
FDA Device · Class II · 2018-06-20 · Angiodynamics Navilyst Medical
Reason: A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens). - RS TANDEM 5F DL BIOFLO PASV, Catalog Number 60M232242
FDA Device · Class II · 2018-06-20 · Angiodynamics Navilyst Medical
Reason: A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens). - RS 5F DL BIOFLO PASV, Catalog Number 60M132324
FDA Device · Class II · 2018-06-20 · Angiodynamics Navilyst Medical
Reason: A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens). - 5F DL BIOFLO PICC, Catalog Number 60M180592
FDA Device · Class II · 2018-06-20 · Angiodynamics Navilyst Medical
Reason: A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens). - BioFlo PICC (NV) 5FDL-55cm Maximal Barrier Nursing Kit w/70cm Nitinol Wire PG, Catalog Number 75-033
FDA Device · Class II · 2018-06-20 · Angiodynamics Navilyst Medical
Reason: A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens). - RS - TANDEM 5F DL BIOFLO MIDLINE, Catalog Number 60M035472
FDA Device · Class II · 2018-06-20 · Angiodynamics Navilyst Medical
Reason: A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens). - CAN 5F DUAL XCELA PICC, Catalog Number 60M701532
FDA Device · Class II · 2018-06-20 · Angiodynamics Navilyst Medical
Reason: A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens). - Bio-Stable 5F SL-55CM IR-145 Kit Valved PG, Catalog Number 45-818
FDA Device · Class II · 2018-06-20 · Angiodynamics Navilyst Medical
Reason: A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens). - BioFlo PICC (Valved) 5FDL-55cm Maximal Barrier Nursing Kit PG, Catalog Number 75-019
FDA Device · Class II · 2018-06-20 · Angiodynamics Navilyst Medical
Reason: A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens). - CAN 5F DL BIOFLO PASV PICC NURSING TRAY, Catalog Number 60M700936
FDA Device · Class II · 2018-06-20 · Angiodynamics Navilyst Medical
Reason: A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens). - XCELA PASV 5F SL 55CM IR-145 Nitinol Wire KIT PG, Catalog Number 25-124
FDA Device · Class II · 2018-06-20 · Angiodynamics Navilyst Medical
Reason: A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens). - Bio-Stable 5F DL-55CM MST-70 KIT Non-Valved with Nitinol Guidewire PG, Catalog Number 45-895
FDA Device · Class II · 2018-06-20 · Angiodynamics Navilyst Medical
Reason: A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens). - Bio-Stable 5F SL-55CM IR-145 Kit Non-Valved with Nitinol GW PG, Catalog Number 45-886
FDA Device · Class II · 2018-06-20 · Angiodynamics Navilyst Medical
Reason: A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens). - Bio-Stable 5F DL-55CM MST-70 KIT Non-Valved PG, Catalog Number 45-871
FDA Device · Class II · 2018-06-20 · Angiodynamics Navilyst Medical
Reason: A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens). - RS TANDEM 5F DL XPP, Catalog Number 60M019881
FDA Device · Class II · 2018-06-20 · Angiodynamics Navilyst Medical
Reason: A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens). - Microintroducer Kit, 5F, Tearaway Sheath/Dilator PG, Catalog Number 45-901
FDA Device · Class II · 2018-06-20 · Angiodynamics Navilyst Medical
Reason: A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens). - RS TANDEM 5F DL BIOFLO PASV, Catalog Number 60M120196
FDA Device · Class II · 2018-06-20 · Angiodynamics Navilyst Medical
Reason: A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens). - Bio-Stable 5F DL-55CM IR-145 Kit Non-Valved PG, Catalog Number 45-872
FDA Device · Class II · 2018-06-20 · Angiodynamics Navilyst Medical
Reason: A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens). - RS TANDEM 5F DL XCELA PICC PASV, Catalog Number 60M181582
FDA Device · Class II · 2018-06-20 · Angiodynamics Navilyst Medical
Reason: A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens). - RS TANDEM 5F DL BIOFLO PICC, Catalog Number 60M250097
FDA Device · Class II · 2018-06-20 · Angiodynamics Navilyst Medical
Reason: A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens). - RS 5F DL BIOFLO PASV, Catalog Number 60M181578
FDA Device · Class II · 2018-06-20 · Angiodynamics Navilyst Medical
Reason: A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens). - BioFlo PICC (NV) 5FSL-55cm Maximal Barrier Nursing Kit w/ 70cm Nitinol Wire PG, Catalog Number 75-032
FDA Device · Class II · 2018-06-20 · Angiodynamics Navilyst Medical
Reason: A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens). - RS 5F DL XCELA PICC, Catalog Number 60M122272
FDA Device · Class II · 2018-06-20 · Angiodynamics Navilyst Medical
Reason: A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens).