Glens Falls, NY, United States
Angiodynamics Inc. (Navilyst Medical Inc.) recalls
9 recalls recorded since 2018, most recently on 22 February 2021. None are listed as ongoing. Status and classification are as published by the FDA.
Recalls9
Ongoing (FDA)0
Terminated or completed9
Class I (FDA)0
Terminated Class II Medical devices
- Recall started
- 22 February 2021
- Terminated
- 19 July 2022
- 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 the kit identified below is affected by this recall action. The Product Description, Product Number, Ref./Catalog Number and Batch/Lot number is provided below. No other products are affected by this recall.
- Distribution
- US Nationwide distribution in the states of AR, CA, CO, FL, HI, IL, IN, KS, MI, MO, NC, ND, NM, NY, OH, OR, PA, SC, TN, TX, VA, WA.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1467-2021, Z-1466-2021
- AngioDynamics Safe Sheath Ultralite - Vascular Introducer/Catheter Introducer Catalogue #: VI10 - Product Usage: For the introduction of various types of pacing leads and catheters.
- Smart Port CT-Implantable Port Catalogue #: CT96STSD-VI, CT96STSA-VI - Product Usage: indicated for any patient requiring repeated access of the vascular system, for delivery of medications, nutritional supplementation,
Terminated Class II Medical devices
- Recall started
- 2 October 2019
- Terminated
- 29 July 2020
- Reason
- The devices are not labelled correctly. End users impacted by this issue may experience a procedural delay.
- Distribution
- The products were distributed to the following US states: LA, MA, OR, VA, and WA.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0411-2020
- Starburst Talon Semi-Flex Electrosurgical Device, Part Number H7877001028451 incorrectly labelled as Starburst MRI Semi-Flex Electrosurgical Device, Part Number H7877001026151
Terminated Class II Medical devices
- Recall started
- 18 September 2019
- Terminated
- 24 September 2020
- 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 a delay to the implantation procedure.
- Distribution
- Worldwide distribution - US Nationwide in the state of CA, CT, FL, GA, IA, IN, KS, KY, MI, MO, MS, MT, NE, NJ, NY, OH, OK, OR, PA, TN, TX, WA, WI and country of Canada.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0502-2020, Z-0504-2020, Z-0501-2020, Z-0505-2020, Z-0503-2020
- BIOFLO 8F SINGLE TITANIUM NON- FILLED; VALVED, UPN H965440250, Cat. No. 44-025 - Product Usage: Long-term access to the central venous system for administration of fluids including but not limited to hydration fluids, ch
- BIOFLO 8F SINGLE PLASTIC FILLED; VALVED, UPN H965440220, Cat. No. 44-022
- BIOFLO 8F SINGLE PLASTIC FILLED; NON-VALVED, UPN H965440140, Cat. No. 44-014 - Product Usage: Long-term access to the central venous system for administration of fluids including but not limited to hydration fluids, chem
- XCELA, 8F SINGLE PLASTIC PORT FILLED, VALVED, UPN H965440400, Cat. No. 44-040 - Product Usage: Long-term access to the central venous system for administration of fluids including but not limited to hydration fluids, che
- BIOFLO 8F SINGLE PLASTIC NON-FILLED; VALVED, UPN H965440210, Cat. No. 44-021 - Product Usage: Long-term access to the central venous system for administration of fluids including but not limited to hydration fluids, chem
Terminated Class II Medical devices
- Recall started
- 17 April 2019
- Terminated
- 9 June 2020
- 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
- Distribution
- Worldwide distribution - US Nationwide distribution and countries of AE AT AU BE CA CH CL CO CZ DE DK DZ EG ES FR GB GE GR HK IE IL IN IQ IT LB LT MC MT MX NL NZ PL PT SG TH TR TW VN ZA
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1700-2019, Z-1702-2019, Z-1704-2019, Z-1701-2019, Z-1703-2019
- AngioDynamics Solero Microwave Tissue Ablation (MTA) System: Solero Generator PG (1) Catalog Number:12740000 UPN: H78712740000 (2) Solero Generator US PG Catalog Number: 12740000US UPN: H78712740000US0 (3
- AngioDynamics Solero Microwave Tissue Ablation (MTA) System: (1) Solero Applicator 14cm PG Catalog Number: 700106001 UPN:H7877001060010; (2)Solero Applicator 14cm PG US Catalog Number:700106001US UPN: H7877001
- AngioDynamics Solero Microwave Tissue Ablation (MTA) System: (1)Solero Applicator 29cm PG Catalog Number:700106003 UPN: H7877001060030 (2)Solero Applicator 29cm PG US Catalog Number:700106003US UPN:H78770010600
- AngioDynamics Solero Microwave Tissue Ablation (MTA) System: (1) Solero Generator Refurbished PG Catalog Number: 12740000D UPN: H78712740000D0 (2) Solero Generator Refurbished US PG Catalog Number: 12740000USD ;U
- AngioDynamics Solero Microwave Tissue Ablation (MTA) System: (1)Solero Applicator 19cm PG Catalog Number: 700106002 UPN: H7877001060020 (2)Solero Applicator 19cm PG US Catalog Number:700106002US UPN: H78770010
Terminated Class II Medical devices
- Recall started
- 16 October 2018
- Terminated
- 26 June 2020
- 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. Although the product under recall has not yet reached its validated expiry date, removal of the affected product is warranted to prevent use beyond the validated expiry date.
- Distribution
- Distributed to accounts in Florida. Foreign distribution to Great Britain.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0595-2019, Z-0596-2019
- Xcela Power Injectable PICC with PASV (XCELA PASV 4F SL 55CM Catheter Kit CE PG), Cat no. 55-711
- BioFlo PICC with ENDEXO and PASV, ( RS 5F DL BIOFLO PASV - MEMORIAL HOSPITAL SYSTEM (LTP) PG) Cat. no. 60M183481
Terminated Class II Medical devices
- Recall started
- 24 July 2018
- Terminated
- 17 May 2019
- 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 Valved Non-Filled
- Distribution
- US Nationwide in the state of IN.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0076-2019
- BioFlo Port with ENDEXO and PASV Technology-AngioDynamics BIOFLO 8F SINGLE PLASTIC NON-FILLED; VALVED PG UPN: H965440210 Catalog Number: 44-021 Box of 1 Port - Product Usage - Long-term access to the central venous sys
Terminated Class II Medical devices
- Recall started
- 10 May 2018
- Terminated
- 13 May 2020
- Reason
- A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens).
- Distribution
- The products were distributed to the following US states: AZ, CA, CO, CT, DC, FL, GA, IL, IN, KS, KY, LA, MD, MI, MN, MO, MS, MT, NC, ND, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, WA, WI, and WV. The products were distributed to the following foreign countries: Canada, China, Ireland, Spain.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2218-2018, Z-2207-2018, Z-2205-2018, Z-2199-2018, Z-2200-2018, Z-2210-2018, Z-2222-2018, Z-2219-2018, Z-2212-2018, Z-2208-2018, Z-2220-2018, Z-2191-2018 and 26 more
- CAN 5F SINGLE XCELA PICC, Catalog Number 60M701531
- 5F DL BIOFLO PASV, Catalog Number 60M141006
- RS 5F DL BIOFLO PASV, Catalog Number 60M132324
- BioFlo Midline 5F DL-20cm MST-45 Kit w/ Two Nitinol Guidewires PG, Catalog Number 46-810
- RS TANDEM 5F DL XPP, Catalog Number 60M019881
- 5F DL BIOFLO PICC, Catalog Number 60M180592
- BioFlo PICC (NV) 5FSL-55cm Maximal Barrier Nursing Kit w/ 70cm Nitinol Wire PG, Catalog Number 75-032
- CAN 5F DUAL XCELA PICC, Catalog Number 60M701532
- and 30 more product lines
Terminated Class II Medical devices
- Recall started
- 18 January 2018
- Terminated
- 21 September 2018
- Reason
- NAMIC Fluid Management Convenience Kits contains a Fluid Delivery Set that was not assembled in accordance with specification, and prevents the device from being used, resulting in a minor delay in procedure.
- Distribution
- Recall conducted to end user level. Recall Notifications were delivered by Fed Express.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1390-2018
- Fluid Management Convenience Kits (Angioplasty Kits) intended to be used in Fluid Management and/or Invasive Pressure Monitoring systems.
Terminated Class II Medical devices
- Recall started
- 17 October 2017
- Terminated
- 14 June 2022
- 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).
- Distribution
- Canada
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2617-2021
- Xcela PICC with PASV Valve Technology/Kit 5 F-55cm; (Maximum Flow Rate 3.5 mL/Sec)-indicated for short or long-term peripheral access to the central venous system for intravenous therapy, including but not limited to, th
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.