Overview of recall records associated with Stryker Neurovascular, including dates, categories and classifications where available.
Classification mix: Class II: 29, Class I: 1.
Embolization coil detachment system devices may experience premature battery drain causing devices to: 1) Not power on; 2) Power on with faint audible and visual indicators; 3) Be unable to…
Stryker Neurovascular has observed that devices with Out of United States (OUS) approved Instructions for Use (IFU) and Packaging Labels (pouch and carton), different configurations, have…
Stryker Neurovascular has observed an increased frequency of PTFE coating damage occurring on the Synchro Guidewires that may be caused by the practice of backloading the guidewire through…
Stryker Neurovascular has observed an increased frequency of PTFE coating damage occurring on the Synchro Guidewires that may be caused by the practice of backloading the guidewire through…
Stryker Neurovascular has observed an increased frequency of PTFE coating damage occurring on the Synchro Guidewires that may be caused by the practice of backloading the guidewire through…
Neurovascular devices did not meet the minimum sample size required for endotoxin testing during manufacturing processes and are out of compliance with the AAMI ST72 standard, so these…
Neurovascular devices did not meet the minimum sample size required for endotoxin testing during manufacturing processes and are out of compliance with the AAMI ST72 standard, so these…
Neurovascular devices did not meet the minimum sample size required for endotoxin testing during manufacturing processes and are out of compliance with the AAMI ST72 standard, so these…
Neurovascular devices did not meet the minimum sample size required for endotoxin testing during manufacturing processes and are out of compliance with the AAMI ST72 standard, so these…
Neurovascular devices did not meet the minimum sample size required for endotoxin testing during manufacturing processes and are out of compliance with the AAMI ST72 standard, so these…
Neurovascular devices did not meet the minimum sample size required for endotoxin testing during manufacturing processes and are out of compliance with the AAMI ST72 standard, so these…
Neurovascular devices did not meet the minimum sample size required for endotoxin testing during manufacturing processes and are out of compliance with the AAMI ST72 standard, so these…
Neurovascular devices did not meet the minimum sample size required for endotoxin testing during manufacturing processes and are out of compliance with the AAMI ST72 standard, so these…
Stryker Neurovascular is recalling their DAC- Distal Access Catheter -038 136cm, a Distal Access Catheter by removal. The reason for the recall is: the DAC Lot #0000486382 was released with…
Microcatheter product label on the carton is missing the microcatheter product drawing/illustration.
Increase in fracture complaints of the flexible, tapered core wire, resulting in stent retriever separation from the core wire during use. The stent retriever can be left behind in the…
The firm has become aware of a potential problem that their Catheters may break/fracture and/or kink/bend if improperly removed from the packaging/dispenser hoop or during catheter use.
The firm has become aware of a potential problem that their Catheters may break/fracture and/or kink/bend if improperly removed from the packaging/dispenser hoop or during catheter use.
The product labels (pouch and carton) for products contain an incorrect value in millimeters (0.036mm) for the Guidewire Outer Diameter dimension. The inches dimension (0.014in) on the…
The product labels (pouch and carton) for products contain an incorrect value in millimeters (0.036mm) for the Guidewire Outer Diameter dimension. The inches dimension (0.014in) on the…
The product labels (pouch and carton) for products contain an incorrect value in millimeters (0.036mm) for the Guidewire Outer Diameter dimension. The inches dimension (0.014in) on the…
The product labels (pouch and carton) for products contain an incorrect value in millimeters (0.036mm) for the Guidewire Outer Diameter dimension. The inches dimension (0.014in) on the…
The product labels (pouch and carton) for products contain an incorrect value in millimeters (0.036mm) for the Guidewire Outer Diameter dimension. The inches dimension (0.014in) on the…
The product labels (pouch and carton) for products contain an incorrect value in millimeters (0.036mm) for the Guidewire Outer Diameter dimension. The inches dimension (0.014in) on the…
This page summarizes recall records in which the official source identifies Stryker Neurovascular as the recalling firm or manufacturer. The number of records should not be treated as a safety rating or a measure of company size, because recall counts depend on product mix, reporting periods and how government records are organized.
Compare the dates, categories and classifications together rather than relying on the total alone. Open an individual record for the recalled product, reason, distribution details and current instructions available from the source.
