Boston Scientific Recalls Sensor Nitinol Wire with Hydrophilic Tip
Boston Scientific is recalling 225 units of Sensor Nitinol Wire with Hydrophilic Tip due to increased complaints about difficulty tracking over the guidewire.
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 2/5 (Moderate).
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 source text describes a procedural delay due to device performance issues but does not report any injuries, illnesses, or fatalities, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Boston Scientific is voluntarily recalling 225 units of Sensor Nitinol Wire with Hydrophilic Tip .0383CM FLEX ANG/150CM. The affected products are identified by Lot Numbers 24538844 and 24647121, and are available in box of 5 (UPN: M0066703101) and single unit (UPN: M0066703100) configurations.
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.
The affected devices were distributed nationwide and in foreign regions including Europe, the Middle East and Africa, the Americas (North and South America), Asia Pacific, and Japan. Healthcare providers should stop using the affected devices and contact Boston Scientific for further instructions.
The recalled product
- Product
- Sensor Nitinol Wire with Hydrophilic Tip .0383CM FLEX ANG/150CM UPN: M0066703101 box 5 UPN: M0066703100 single unit
- Manufacturer
- Boston Scientific
- Hazard
- Affected units
- 225
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 (2)
- Lot Numbers: 24538844
- 24647121
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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