Stryker Neurovascular Recalls

All product recalls associated with Stryker Neurovascular.

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Recall Summary

Total Recalls

20

Past Year

0

Class I (Serious)

0

Most Recent

Aug 2024

Data from FDA, USDA, CPSC, and NHTSA public records. Recall counts vary by company size, industry, and reporting practices. Always check official sources for current information.

Showing 1–20 of 20 recalls

Trevo Trak Microcatheter (Stryker) – Packaging Label Issue (2024)

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 been erroneously distributed to customers in the US.

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FDAAug 30, 2024Nationwide• Stryker Neurovascular

Trevo ProVue (Stryker) – Endotoxin Testing (2024)

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 devices may exceed the acceptable limits of endotoxin levels; high levels of endotoxins may increase the risk of fever, shock and aseptic meningitis.

FDAApr 23, 2024Nationwide• Stryker Neurovascular

FlowGate2 (Stryker) – Endotoxin Testing (2024)

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 devices may exceed the acceptable limits of endotoxin levels; high levels of endotoxins may increase the risk of fever, shock and aseptic meningitis.

FDAApr 23, 2024Nationwide• Stryker Neurovascular

Trevo NXT ProVue (Stryker) – Endotoxin Testing (2024)

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 devices may exceed the acceptable limits of endotoxin levels; high levels of endotoxins may increase the risk of fever, shock and aseptic meningitis.

FDAApr 23, 2024Nationwide• Stryker Neurovascular

Trevo Trak Microcatheter (Stryker) – Endotoxin Testing (2024)

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 devices may exceed the acceptable limits of endotoxin levels; high levels of endotoxins may increase the risk of fever, shock and aseptic meningitis.

FDAApr 23, 2024Nationwide• Stryker Neurovascular

Trevo Pro Microcatheter (Stryker) – Endotoxin Testing (2024)

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 devices may exceed the acceptable limits of endotoxin levels; high levels of endotoxins may increase the risk of fever, shock and aseptic meningitis.

FDAApr 23, 2024Nationwide• Stryker Neurovascular

Trevo XP ProVue Retriever (Stryker) – Endotoxin Testing (2024)

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 devices may exceed the acceptable limits of endotoxin levels; high levels of endotoxins may increase the risk of fever, shock and aseptic meningitis.

FDAApr 23, 2024Nationwide• Stryker Neurovascular

Synchro Guidewire (Stryker) – Endotoxin Testing (2024)

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 devices may exceed the acceptable limits of endotoxin levels; high levels of endotoxins may increase the risk of fever, shock and aseptic meningitis.

FDAApr 23, 2024Nationwide• Stryker Neurovascular

DAC Device (Stryker) – Endotoxin Testing (2024)

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 devices may exceed the acceptable limits of endotoxin levels; high levels of endotoxins may increase the risk of fever, shock and aseptic meningitis.

FDAApr 23, 2024Nationwide• Stryker Neurovascular

Synchro2 Guidewires (Stryker) – PTFE coating damage (2024)

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 the optional introducer accessory. This issue is limited to certain lots of the Synchro Guidewire that contain an older version of the introducer accessory. Due to variation in the manufacturing process of the supplier of the introducer accessory, certain lots of introducers have sharper than intended edges that can peel off the PTFE coating when physicians use a technique known as backloading. Users with impacted product in their inventory are cautioned not to use this backloading technique.

FDAApr 18, 2024Nationwide• Stryker Neurovascular

Synchro Neuro Guidewires (Stryker) – PTFE coating damage (2024)

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 the optional introducer accessory. This issue is limited to certain lots of the Synchro Guidewire that contain an older version of the introducer accessory. Due to variation in the manufacturing process of the supplier of the introducer accessory, certain lots of introducers have sharper than intended edges that can peel off the PTFE coating when physicians use a technique known as backloading. Users with impacted product in their inventory are cautioned not to use this backloading technique.

FDAApr 18, 2024Nationwide• Stryker Neurovascular

Synchro SELECT Guidewires (Stryker) – PTFE coating damage (2024)

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 the optional introducer accessory. This issue is limited to certain lots of the Synchro Guidewire that contain an older version of the introducer accessory. Due to variation in the manufacturing process of the supplier of the introducer accessory, certain lots of introducers have sharper than intended edges that can peel off the PTFE coating when physicians use a technique known as backloading. Users with impacted product in their inventory are cautioned not to use this backloading technique.

FDAApr 18, 2024Nationwide• Stryker Neurovascular

Distal Access Catheter (Stryker) – Unspecified Recall Reason (2024)

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 out-of-specification endotoxin results.

FDAApr 3, 2024Nationwide• Stryker Neurovascular

Stryker Neurovascular: Trevo Trak 21 Microcatheter, REF: 90338. TREVO NXT 3X32+...

Microcatheter product label on the carton is missing the microcatheter product drawing/illustration.

FDAJun 3, 2022Nationwide• Stryker Neurovascular

Stryker Neurovascular: Trevo XP ProVue Retriever, REF (Size): 90182 (4MM x 20MM...

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 vasculature.

FDASep 21, 2020AL, AK, AZ +44 more• Stryker Neurovascular