Boston Scientific Recalls Sensor Nitinol Wire Due to Tracking Issues
Boston Scientific is recalling Sensor Nitinol Wires with Hydrophilic Tips because an increased rate of complaints indicates difficulty tracking over the guidewire, which may cause procedural delays.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II. The hazard involves procedural delays and device exchange rather than direct injury or death, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Boston Scientific is voluntarily recalling specific lots of Sensor Nitinol Wire with Hydrophilic Tip .035 3CM FLEX STR/150CM. The recall affects 25,956 units distributed nationwide and in foreign regions including Europe, the Middle East, Africa, the Americas, Asia Pacific, and Japan.
The recall was initiated due to an increase in the rate of complaints regarding difficulty or inability to track over the guidewire. This issue may result in procedural delays due to the need to exchange the affected device during a procedure.
Healthcare providers and facilities should identify and stop using the affected devices. The specific lot numbers are listed in the official recall notice. Consumers should contact their healthcare provider if they have questions regarding this recall.
The recalled product
- Product
- Sensor Nitinol Wire with Hydrophilic Tip .035 3CM FLEX STR/150CM UPN: M0066703051 box 5 UPN: M0066703050 single unit
- Manufacturer
- Boston Scientific
- Affected units
- 25,956
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)
- Lot Numbers: 24423656
- 24423820
- 24424087
- 24427952
- 24427959
- 24428330
- 24430010
- 24437882
- 24440182
- 24440998
- 24444952
- 24446611
- 24447516
- 24447658
- 24447722
- 24447735
- 24451828
- 24452126
- 24452132
- 24452266
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 12 recalled by Boston Scientific 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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