Boston Scientific Recalls Sensor Nitinol Wire Due to Tracking Issues
Boston Scientific is recalling specific lots of Sensor Nitinol Wire with Hydrophilic Tip because increased complaints indicate difficulty tracking over the guidewire, which may cause procedural delays.
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: The recall is classified as FDA Class II and involves a risk-of-harm product (medical device) where the hazard is procedural delay rather than reported injury or death, fitting the 'High' severity criteria for risk-of-harm products without reported illness.
Plain-English summary
Boston Scientific is recalling 1,785 units of Sensor Nitinol Wire with Hydrophilic Tip .035 3CM FLEX /150CM. The affected products are identified by specific lot numbers and are distributed nationwide as well as in 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 lots. Boston Scientific is the recalling firm responsible for managing this Class II recall.
The recalled product
- Product
- Sensor Nitinol Wire with Hydrophilic Tip .035 3CM FLEX /150CM UPN: M0066703061 box 5 UPN: M0066703060 single unit
- Manufacturer
- Boston Scientific
- Affected units
- 1,785
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)
- Lot Numbers: 24484631
- 24494135
- 24494288
- 24533782
- 24584655
- 24617736
- 24625474
- 24665994
- 24723912
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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