Synchro2 Guidewires: PTFE coating damage from improper backloading technique
Stryker Neurovascular is recalling certain lots of Synchro2 Guidewires due to PTFE coating damage caused by backloading through an introducer accessory with manufacturing variations. Affected users should discontinue the backloading technique.
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 device recall without reported illnesses or injuries. The hazard (PTFE coating damage) presents a risk of harm during neurovascular procedures but has not resulted in documented adverse events, fitting the criterion for High severity with risk-of-harm products where injury has not yet been reported.
Plain-English summary
The Synchro2 Guidewires are steerable medical devices with a shapeable tip used in endovascular diagnosis and therapy of neurovascular disease. Approximately 373,246 units have been distributed worldwide, including throughout the United States.
Stryker Neurovascular identified an increased frequency of PTFE coating damage on certain lots of Synchro guidewires. The damage occurs when the guidewire is backloaded through an optional introducer accessory that was manufactured with sharper-than-intended edges due to supplier manufacturing variations. These sharp edges can peel off the protective PTFE coating when the backloading technique is used.
This issue affects only certain lots that contain an older version of the introducer accessory. No injuries or adverse events have been reported. Stryker recommends that healthcare providers with affected product in inventory should discontinue use of the backloading technique with these guidewires to prevent coating damage that could compromise device integrity during procedures.
The recalled product
- Product
- The Synchro2 Guidewires are a steerable guidewire family with a shapeable tip and are available in straight and pre-shaped versions. The outside diameters of the guidewires are 0.014 in. The guidewires are compatible with existing microcatheters used in common procedures such as…
- Manufacturer
- Stryker Neurovascular
- Affected units
- 373,246
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: M00326110/04546540688736/0000064108
- 0000065017
- 0000065616
- 0000066470
- 0000066581
- 0000067561
- 0000067801
- 0000068246
- 0000069276
- 0000071094
- 0000071841
- 0000073548
- 0000075207
- 0000077751
- 0000078371
- 0000078837
- 0000080548
- 0000080988
- 0000082965
- 0000083195
Distribution
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
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