Recall MonitorSoft-Vu and Accu-Vu 4 FR Angiographic Catheters
· Published by Health Canada · Official notice
Details
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.