Synchro Guide Wires Recalled for Inadequate Endotoxin Testing
Stryker Neurovascular is recalling 2,859 Synchro guide wires in multiple configurations due to inadequate endotoxin testing during manufacturing. The devices may exceed acceptable endotoxin limits, increasing the risk of fever, shock, and aseptic meningitis.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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: FDA Class II recall without reported illnesses or injuries. The hazard is theoretical—devices may exceed endotoxin limits due to inadequate testing—with potential for serious complications (fever, shock, aseptic meningitis) but no confirmed patient harm reported. This fits the 'risk-of-harm products where injury has not yet been reported' criterion.
Plain-English summary
Stryker Neurovascular is recalling multiple configurations of Synchro guide wires. During manufacturing, these devices did not meet the minimum sample size required for endotoxin testing. This noncompliance with AAMI ST72 standards means the devices may have endotoxin levels exceeding acceptable limits.
High endotoxin levels may increase the risk of fever, shock, and aseptic meningitis.
The recall affects 2,859 units distributed worldwide, including throughout the United States. The recalled products are Synchro .014" guide wires (35 cm tip, Catalog M00313010; 300 cm length, Catalog M00313310) and Synchro .010" soft straight wires (200 cm, Catalog M00316310; 300 cm, Catalog M00316330). Specific lot numbers are identified in the FDA recall notice.
The recalled product
- Product
- Synchro .014"guide wire, 35 cm tip, Catalog: M00313010 Synchro .014 guide wire, 300 cm length, Catalog: M00313310 SYNCHRO .010 WIRE SOFT STRAIGHT 200cm, Catalog: M00316310 SYNCHRO .010 WIRE SOFT STRAIGHT 300cm, Catalog: M00316330
- Manufacturer
- Stryker Neurovascular
- Category
- Medical Device — Neurovascular
- Affected units
- 2,859
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 (9)
- Catalog/UDI-DI/Lot: M00313010/07613252186922/123279
- 123364
- 123404
- 123985
- 124214
- 124216
- M00313310/07613252186946/123494
- M00316310/07613252187158/123851
- M00316330/07613252187165/124156
Distribution
Part of a larger recall action
This product is one of 8 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.
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