The Recall Desk
HighFDA (Devices)·Z-1939-2024·Announced 2024-06-12

Stryker Synchro Neuro Guidewires Recalled for PTFE Coating Damage Risk

Stryker Neurovascular is recalling certain lots of Synchro Neuro Guidewires due to PTFE coating damage that can occur when using a backloading technique with the optional introducer. Clinicians should avoid the backloading technique with affected product.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: These are risk-of-harm products used in critical neurovascular procedures. While PTFE coating damage is preventable through technique modification, the potential for serious harm if a defect occurs during a critical vascular intervention justifies a High severity classification despite no injuries being reported.

Plain-English summary

Stryker Neurovascular is recalling 105,286 units of Synchro Neuro Guidewires across multiple lot numbers. These steerable guidewires with shapeable tips are used in endovascular procedures for diagnosis and treatment of neurovascular disease. The guidewires feature a PTFE (polytetrafluoroethylene) coating that provides lubricity and aids in vessel navigation.

The manufacturer has observed an increased frequency of PTFE coating damage on the guidewires. This damage occurs when the guidewire is inserted through the optional introducer accessory using a technique called backloading. The issue is limited to certain product lots containing an older version of the introducer. Due to manufacturing variations, those introducers have sharper than intended edges that can peel off the PTFE coating during the backloading process.

The affected product has been distributed worldwide, including throughout all U.S. states and territories, and to multiple countries internationally. Healthcare facilities and clinicians with affected product in their inventory should avoid using the backloading technique with these guidewires to prevent coating damage. Review your inventory against the provided lot numbers to determine if your facility has affected product.

The recalled product

Product
The Synchro Neuro Guidewires are a steerable guidewire family with a shapeable tip. The outside diameter of the Synchro 10 guidewire is 0.010in. The outside diameter of the Syncrho 14 guidewire is 0.014in. The guidewires are compatible with existing microcatheters used in common
Manufacturer
Stryker Neurovascular
Category
Medical Device — Neurovascular Instruments
Hazard
Affected units
105,286

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

  • Catalog/UDI-DI/Lots: M00316310/07613252187158/0000131357
  • 0000132153
  • 0000132740
  • 0000135026
  • 0000138147
  • 0000138148
  • 0000138579
  • 0000142533
  • 0000144961
  • 0000145874
  • 0000154419
  • 0000156324
  • 0000156614
  • 0000158907
  • 0000158911
  • 0000164603
  • 0000173346
  • 0000173701
  • 0000173702
  • 0000173771

Distribution

Distributed nationwide across the United States.

The notice also names 52 states specifically:

Part of a larger recall action

This product is one of 3 recalled by Stryker Neurovascular under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 3 products in this recall →

Related recalls

Same manufacturer · Stryker Neurovascular

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Same hazard · coating damage

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