Synchro SELECT Guidewires may have PTFE coating damage
Stryker Neurovascular recalls certain lots of Synchro SELECT Guidewires due to PTFE coating damage that may occur when using a backloading technique. The damage is caused by sharper-than-intended edges on older introducer versions.
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: FDA Class II recall for a manufacturing defect affecting device coating integrity. No illnesses or injuries have been reported, limiting the score to High per the severity rubric.
Plain-English summary
Stryker Neurovascular is recalling certain lots of Synchro SELECT Guidewires, steerable guidewires used in endovascular procedures for diagnosis and treatment of neurovascular disease. A total of 41,074 units have been distributed worldwide.
The company has identified an increased frequency of PTFE coating damage occurring on the guidewires. The damage is caused by the practice of backloading the guidewire through the optional introducer accessory. This issue is limited to certain lots containing an older version of the introducer accessory. The root cause is variation in the manufacturing process of the introducer supplier, which resulted in certain lots having sharper-than-intended edges that can peel off the PTFE coating.
Users with impacted product in their inventory should not use the backloading technique with these guidewires.
The recalled product
- Product
- The Synchro SELECT 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 0.014in. The guidewires are compatible with existing microcatheters used in common procedures s
- Manufacturer
- Stryker Neurovascular
- Hazard
- ptfe-coating-damage
- device-defect
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: SSFT215PRE/07613327508598/0000139994
- 0000144321
- 0000146842
- 0000154408
- SSFT215STR/07613327508574/0000122897
- 0000123151
- 0000123405
- 0000124931
- 0000125040
- 0000125719
- 0000125720
- 0000125787
- 0000126356
- 0000129220
- 0000129221
- 0000130861
- 0000131723
- 0000132954
- 0000133179
- 0000137045
Distribution
Distributed nationwide across the United States.
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