Angiodynamics Worldwide Headquarters
Latham, NY, US
Angiodynamics Worldwide Headquarters appears in FDA device records in Latham, NY. FDA records list no 510(k) clearances, no PMA records and no registered establishments. As of , FDA records show 82 recalls for this company.
FDA records held for this company
- 510(k) clearances
- 0
- PMA records
- 0
- Recall records
- 82
- Registered establishments
- 0
510(k) clearance history
No 510(k) clearance records for this company in the ingested FDA data.
No 510(k) clearance records in the ingested FDA data.
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
No FDA product codes recorded against this company.
Recall records
Showing 25 of 82| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-2180-2012 | AngioDynamics Angiographic catheter --- Soft-Vu (JB-1) Non-braided. --- Size: 5F; Length: 100cm; designed to accept guidewire: .035 in. --- Catalog No. [REF]: 10734201. Packaged in boxes of 5 catheters each, with manufacturer listed as AngioDynamics, Inc., Queensbury, NY USA. Intended use: angiographic diagnosis. | AngioDynamics is recalling one lot of Soft-Vu Angiographic catheters because one of the catheter pouches within the outer box may be mislabeled. | Class II | Terminated | |
| Z-1069-2012 | AngioDynamics SPECIAL ORDER Morpheus Smart PICC CT --- 4F Single Lumen 65cm --- Max CT Flow Rate: 4mL/sec --- Kit Contains: --- 1 each Nitinol Guidewire, 0.46mm (0.018in.) x 130cm --- Catalog No. [REF] 52110902 --- [Mfg symbol] AngioDynamics, Inc., 603 Queensbury, NY USA 12804. Indicated for short or long term peripheral access to the central venous system for intravenous therapy and power injections of contrast media. | The Morpheus Smart PICC label states the kit contains a Nitinol guidewire; however the kit contains a Platinum guidewire. | Terminated | ||
| Z-1068-2012 | AngioDynamics SPECIAL ORDER Morpheus Smart PICC CT --- 5F Dual Lumen 65cm --- Max CT Flow Rate: 4mL/sec --- Kit Contains: --- 1 each Nitinol Guidewire, 0.46mm (0.018in.) x 130cm --- Catalog No. [REF] 52110901 --- [Mfg symbol] AngioDynamics, Inc., 603 Queensbury, NY USA 12804. Indicated for short or long term peripheral access to the central venous system for intravenous therapy and power injections of contrast media. | The Morpheus Smart PICC label states the kit contains a Nitinol guidewire; however the kit contains a Platinum guidewire. | Terminated | ||
| Z-1114-2012 | AngioDynamics BENEPHIT CV Infusion System Targeted Renal Therapy Infusion System --- Catalog No. [REF] 60040 --- Manufactured in USA --- [Mfg symbol] AngioDyanamics, 603 Queensbury Avenue, Queensbury, NY USA 12804. Intended to facilitate targeted renal therapy, or TRT, the delivery of physician-specific agents to the kidneys via the renal arteries. | The Benephit CV Infusion System contains a Sheath Y Connector that has the potential to develop cracks. | Terminated | ||
| Z-1113-2012 | AngioDynamics BENEPHIT CV Infusion System Targeted Renal Therapy Infusion System --- Catalog No. [REF] 60030 --- Manufactured in USA --- [Mfg symbol] AngioDyanamics, 603 Queensbury Avenue, Queensbury, NY USA 12804. Intended to facilitate targeted renal therapy, or TRT, the delivery of physician-specific agents to the kidneys via the renal arteries. | The Benephit CV Infusion System contains a Sheath Y Connector that has the potential to develop cracks. | Terminated | ||
| Z-1112-2012 | AngioDynamics BENEPHIT CV Infusion System Targeted Renal Therapy Infusion System --- Catalog No. [REF] 60035 --- Manufactured in USA --- [Mfg symbol] AngioDyanamics, 603 Queensbury Avenue, Queensbury, NY USA 12804. Intended to facilitate targeted renal therapy, or TRT, the delivery of physician-specific agents to the kidneys via the renal arteries. | The Benephit CV Infusion System contains a Sheath Y Connector that has the potential to develop cracks. | Terminated | ||
| Z-0918-2012 | NanoKnife Irreversible Electroporation System. System consists of multiple components: Generator, footswitch, disposable electrode. System is manufactured by AngioDynamics, Inc. --- Catalog #20300101 Intended use: the generator system with six outputs is indicated for surgical ablation of soft tissue. | Angiodynamics was marketing the NanoKnife System with the ablation zone estimator feature in the US without FDA clearance. | Terminated | ||
| Z-0912-2012 | AngioDynamics Special Order Morpheus Smart PICC CT 65cm 5F Dual Lumen with Reverse Taper --- Max CT Flow Rate: 4mL/sec --- Injector Pressure Limit --- Catalog No.: 52102638--- Made in the USA --- [Manufacturer symbol] AngioDynamics, 603 Queensbury Avenue, Queensbury, NY 12804 indicated for short or long term peripheral access to the central venous system for intravenous therapy and power injections of contrast media. | The red luer on the Morpheus CT PICC (Peripherally Inserted Central Catheter) has the potential to crack during use of the product. | Terminated | ||
| Z-0911-2012 | AngioDynamics Special Order Morpheus Smart PICC CT 65cm 6F Dual Lumen with Reverse Taper --- Max CT Flow Rate: 6mL/sec --- Injector Pressure Limit --- Catalog No.: 52102624 --- Made in the USA --- [Manufacturer symbol] AngioDynamics, 603 Queensbury Avenue, Queensbury, NY 12804 indicated for short or long term peripheral access to the central venous system for intravenous therapy and power injections of contrast media. | The red luer on the Morpheus CT PICC (Peripherally Inserted Central Catheter) has the potential to crack during use of the product. | Terminated | ||
| Z-0910-2012 | AngioDynamics Special Order Morpheus Smart PICC CT 65cm 5F Dual Lumen with Reverse Taper --- Max CT Flow Rate: 4mL/sec --- Injector Pressure Limit --- Catalog No.: 52102618 --- Made in the USA --- [Manufacturer symbol] AngioDynamics, 603 Queensbury Avenue, Queensbury, NY 12804 indicated for short or long term peripheral access to the central venous system for intravenous therapy and power injections of contrast media. | The red luer on the Morpheus CT PICC (Peripherally Inserted Central Catheter) has the potential to crack during use of the product. | Terminated | ||
| Z-0909-2012 | AngioDynamics Special Order Morpheus Smart PICC CT 65cm 5F Dual Lumen with Reverse Taper --- Max CT Flow Rate: 4mL/sec --- Injector Pressure Limit --- Catalog No.: 52100602 --- Made in the USA --- [Manufacturer symbol] AngioDynamics, 603 Queensbury Avenue, Queensbury, NY 12804 indicated for short or long term peripheral access to the central venous system for intravenous therapy and power injections of contrast media. | The red luer on the Morpheus CT PICC (Peripherally Inserted Central Catheter) has the potential to crack during use of the product. | Terminated | ||
| Z-0908-2012 | AngioDynamics Morpheus Smart PICC CT 6F Triple Lumen w/ Reverse Taper 55cm --- Max CT Flow Rate: 5mL/sec --- Catalog No.: 12110941 --- AngioDynamics, Inc., 603 Queensbury Avenue, Queensbury, NY 12804 --- Assembled and Packaged in the USA. indicated for short or long term peripheral access to the central venous system for intravenous therapy and power injections of contrast media. | The red luer on the Morpheus CT PICC (Peripherally Inserted Central Catheter) has the potential to crack during use of the product. | Terminated | ||
| Z-0907-2012 | AngioDynamics Morpheus Smart PICC CT with Stylet 5F Dual Lumen w/ Reverse Taper 55cm --- Max CT Flow Rate: 5mL/sec --- Catalog No.: 12110937 --- AngioDynamics, Inc., 603 Queensbury Avenue, Queensbury, NY 12804 --- Assembled and Packaged in the USA. indicated for short or long term peripheral access to the central venous system for intravenous therapy and power injections of contrast media. | The red luer on the Morpheus CT PICC (Peripherally Inserted Central Catheter) has the potential to crack during use of the product. | Terminated | ||
| Z-0906-2012 | AngioDynamics Morpheus Smart PICC CT 5F Dual Lumen w/ Reverse Taper 55cm --- Max CT Flow Rate: 5mL/sec --- Catalog No.: 12110936 --- AngioDynamics, Inc., 603 Queensbury Avenue, Queensbury, NY 12804 --- Assembled and Packaged in the USA. indicated for short or long term peripheral access to the central venous system for intravenous therapy and power injections of contrast media. | The red luer on the Morpheus CT PICC (Peripherally Inserted Central Catheter) has the potential to crack during use of the product. | Terminated | ||
| Z-0905-2012 | AngioDynamics Morpheus Smart PICC CT 5F Dual Lumen w/ Reverse Taper 65cm --- Max CT Flow Rate: 4mL/sec --- Catalog No.: 12110934 --- AngioDynamics, Inc., 603 Queensbury Avenue, Queensbury, NY 12804 --- Assembled and Packaged in the USA. indicated for short or long term peripheral access to the central venous system for intravenous therapy and power injections of contrast media. | The red luer on the Morpheus CT PICC (Peripherally Inserted Central Catheter) has the potential to crack during use of the product. | Terminated | ||
| Z-0904-2012 | AngioDynamics Morpheus Smart PICC CT with Stylet 5F Dual Lumen w/ Reverse Taper 65cm --- Max CT Flow Rate: 4mL/sec --- Catalog No.: 12110929 --- AngioDynamics, Inc., 603 Queensbury Avenue, Queensbury, NY 12804 --- Assembled and Packaged in the USA. indicated for short or long term peripheral access to the central venous system for intravenous therapy and power injections of contrast media. | The red luer on the Morpheus CT PICC (Peripherally Inserted Central Catheter) has the potential to crack during use of the product. | Terminated | ||
| Z-0903-2012 | AngioDynamics Morpheus Smart PICC CT with Stylet 5F Dual Lumen 65cm --- Max CT Flow Rate: 4mL/sec --- Catalog No.: 12110923 --- AngioDynamics, Inc., 603 Queensbury Avenue, Queensbury, NY 12804 --- Assembled and Packaged in the USA. indicated for short or long term peripheral access to the central venous system for intravenous therapy and power injections of contrast media. | The red luer on the Morpheus CT PICC (Peripherally Inserted Central Catheter) has the potential to crack during use of the product. | Terminated | ||
| Z-0902-2012 | AngioDynamics Morpheus Smart PICC CT 5F Dual Lumen w/ Reverse Taper 65cm --- Max CT Flow Rate: 4mL/sec --- Catalog No.: 12110919 --- AngioDynamics, Inc., 603 Queensbury Avenue, Queensbury, NY 12804 --- Assembled and Packaged in the USA. indicated for short or long term peripheral access to the central venous system for intravenous therapy and power injections of contrast media. | The red luer on the Morpheus CT PICC (Peripherally Inserted Central Catheter) has the potential to crack during use of the product. | Terminated | ||
| Z-0901-2012 | AngioDynamics Morpheus Smart PICC CT 6F Dual Lumen w/ Reverse Taper 65cm --- Max CT Flow Rate: 6mL/sec --- Catalog No.: 12110918 --- AngioDynamics, Inc., 603 Queensbury Avenue, Queensbury, NY 12804 --- Assembled and Packaged in the USA. indicated for short or long term peripheral access to the central venous system for intravenous therapy and power injections of contrast media. | The red luer on the Morpheus CT PICC (Peripherally Inserted Central Catheter) has the potential to crack during use of the product. | Terminated | ||
| Z-0900-2012 | AngioDynamics Morpheus Smart PICC CT 5F Dual Lumen w/ Reverse Taper 65cm --- Max CT Flow Rate: 4mL/sec --- Catalog No.: 12110917 --- AngioDynamics, Inc., 603 Queensbury Avenue, Queensbury, NY 12804 --- Assembled and Packaged in the USA. indicated for short or long term peripheral access to the central venous system for intravenous therapy and power injections of contrast media. | The red luer on the Morpheus CT PICC (Peripherally Inserted Central Catheter) has the potential to crack during use of the product. | Terminated | ||
| Z-0899-2012 | AngioDynamics Morpheus Smart PICC CT 5F Dual Lumen 65cm --- Max CT Flow Rate: 4mL/SEC --- Catalog No.: 12110904 --- AngioDynamics, Inc., 603 Queensbury Avenue, Queensbury, NY 12804 --- Assembled and Packaged in the USA. indicated for short or long term peripheral access to the central venous system for intravenous therapy and power injections of contrast media. | The red luer on the Morpheus CT PICC (Peripherally Inserted Central Catheter) has the potential to crack during use of the product. | Terminated | ||
| Z-0898-2012 | AngioDynamics Morpheus Smart PICC CT 65cm 6F Dual Lumen --- Max CT Flow Rate: 6mL/SEC --- Injector Pressure Limit: 300 PSI --- Catalog No. [REF] 12104830 --- Made in the USA --- [Manufacturing symbol] AngioDynamics, 603 Queensbury Avenue, Queensbury, NY USA 12804 indicated for short or long term peripheral access to the central venous system for intravenous therapy and power injections of contrast media. | The red luer on the Morpheus CT PICC (Peripherally Inserted Central Catheter) has the potential to crack during use of the product. | Terminated | ||
| Z-0897-2012 | AngioDynamics Morpheus Smart PICC CT 65cm 5F Dual Lumen --- Max CT Flow Rate: 4mL/SEC --- Injector Pressure Limit: 300 PSI --- Catalog No. [REF] 12104821 --- Made in the USA --- [Manufacturing symbol] AngioDynamics, 603 Queensbury Avenue, Queensbury, NY USA 12804 indicated for short or long term peripheral access to the central venous system for intravenous therapy and power injections of contrast media. | The red luer on the Morpheus CT PICC (Peripherally Inserted Central Catheter) has the potential to crack during use of the product. | Terminated | ||
| Z-0896-2012 | AngioDynamics Morpheus Smart PICC CT 65cm 6F Dual Lumen --- Max CT Flow Rate: 6mL/SEC --- Injector Pressure Limit: 300 PSI --- Catalog No. [REF] 12104814 --- Made in the USA --- [Manufacturing symbol] AngioDynamics, 603 Queensbury Avenue, Queensbury, NY USA 12804 indicated for short or long term peripheral access to the central venous system for intravenous therapy and power injections of contrast media. | The red luer on the Morpheus CT PICC (Peripherally Inserted Central Catheter) has the potential to crack during use of the product. | Terminated | ||
| Z-0895-2012 | AngioDynamics Morpheus Smart PICC CT 65cm 5F Dual Lumen --- Max CT Flow Rate: 4mL/SEC --- Injector Pressure Limit: 300 PSI --- Catalog No. [REF] 12104813 --- Made in the USA --- [Manufacturing symbol] AngioDynamics, 603 Queensbury Avenue, Queensbury, NY USA 12804 indicated for short or long term peripheral access to the central venous system for intravenous therapy and power injections of contrast media. | The red luer on the Morpheus CT PICC (Peripherally Inserted Central Catheter) has the potential to crack during use of the product. | Terminated |
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Data as of , FDA export datePage updated Source: openFDA, public domain