Soft-Vu and Accu-Vu 4 FR Angiographic Catheters
Brand(s)
Summary
Contact the manufacturer if you require additional information.
Affected products
Affected products |
Lot or serial number |
Model or catalogue number |
|---|---|---|
Soft-Vu Angiographic Catheters: Berentstein: (Braided & Non) |
More than 10 numbers, contact manufacturer. |
10714009 |
Soft-Vu Angiographic Catheters: Berentstein: (Braided & Non) |
More than 10 numbers, contact manufacturer. |
10714016 |
Accu-Vu Sizing Catheter - Pigtail Flush |
More than 10 numbers, contact manufacturer. |
13709804 |
Soft-Vu Angigraphic Catheters: Shepherd Hook (Braided & Non) |
More than 10 numbers, contact manufacturer. |
H787107100315 |
Soft-Vu Angiographic Catheters - Omni Flush |
More than 10 numbers, contact manufacturer. |
10732301 |
Soft-Vu Angiographic Catheters - Omni Flush |
More than 10 numbers, contact manufacturer. |
10714001 |
Soft-Vu Angiographic Flush Catheters: Pigtail |
More than 10 numbers, contact manufacturer. |
10707103 |
Soft-Vu Angiographic Flush Catheters: Pigtail |
More than 10 numbers, contact manufacturer. |
10714002 |
Soft-Vu Angiographic Selective Catheters: Cobra (Braided & Non) |
More than 10 numbers, contact manufacturer. |
10714018 |
Soft-Vu Angiographic Selective Catheters: Cobra (Braided & Non) |
More than 10 numbers, contact manufacturer. |
10714017 |
Soft-Vu Angiographic Catheters - Kumpe |
More than 10 numbers, contact manufacturer. |
10714021 |
Soft-Vu Angiographic Catheters - Kumpe |
More than 10 numbers, contact manufacturer. |
10714014 |
Soft-Vu Angiographic Catheters - Kumpe |
More than 10 numbers, contact manufacturer. |
10734301 |
Issue
AngioDynamics, Inc., is conducting a voluntary medical device field safety corrective action or recall to the end-user level based on the non-conformance of a molded hub in specific models and lots of Soft-Vu and Accu-Vu 4 fr angiographic catheters. The affected Soft-Vu and Accu-Vu 4 fr angiographic catheters being recalled (removed) contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the catheter hub.
AngioDynamics has become aware of the non-conformance by way of multiple complaints associated with the affected angiographic catheter devices; however, there have been no complaints or events that occurred in Canada. There are no reports of patient injury as a result of this issue.
Additional information
Details
| AngioDynamics, Inc. |
| 603 Queensbury Avenue, Queensbury, New York, United States, 12804 |
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