Daig Livewire Steerable BDB Electrophysiology Catheter Recall
Stryker Sustainability Solutions is recalling Daig Livewire Steerable BDB reprocessed electrophysiology catheters due to incomplete seals on the sterile product.
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 recall involving a sterile medical device with incomplete seals that could compromise sterility, creating a risk of infection. No illnesses or injuries have been reported, but the hazard is not theoretical—defective seals on a sterile product used in invasive electrophysiology procedures present a significant risk of harm.
Plain-English summary
Stryker Sustainability Solutions is recalling Daig Livewire Steerable BDB reprocessed electrophysiology catheters, Product Number 401918, due to incomplete seals on the sterile product. The affected units are identified by UDI 00885825007324 and Lot Numbers 4101996 and 4175347.
The recalled product has been distributed nationwide in the United States as well as in Israel and Canada. A total of 2 units were involved in this recall. The incomplete seals may compromise the sterility of the product.
Patients or healthcare providers who have this product should contact Stryker Sustainability Solutions for instructions on how to return or dispose of the recalled catheters. Consult with your healthcare provider if you have questions about treatment alternatives.
The recalled product
- Product
- Daig Livewire Steerable BDB, Product Number 401918, REPROCESSED ELECTROPHYSIOLOGY CATHETER
- Manufacturer
- Stryker Sustainability Solutions
- Affected units
- 2
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 (3)
- UDI 00885825007324
- Lot Numbers: 4101996
- 4175347.
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 26 recalled by Stryker Sustainability Solutions 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 26 products in this recall →Related recalls
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