Reprocessed Electrophysiology Catheter Daig Livewire Steerable recalled
Stryker Sustainability Solutions is recalling Daig Livewire Steerable reprocessed electrophysiology catheters due to incomplete seals on the sterile product. The recall affects 19 units distributed nationwide in the US, Israel, and Canada.
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: This is an FDA Class II medical device recall with a sterile barrier compromise (incomplete seal). Although no reported illnesses or injuries are mentioned in the source, sterile product integrity issues create a risk of contamination and infection, which qualifies as a high-risk-of-harm medical device defect.
Plain-English summary
Stryker Sustainability Solutions is recalling the Daig Livewire Steerable, Product Number 401582 reprocessed electrophysiology catheter. The reason for the recall is incomplete seals on the sterile product.
A total of 19 units were affected by this recall. The product was distributed in the United States, Israel, and Canada.
The affected lot numbers are: 3002664, 4092049, 4580888, 4627994, 4778840, 4860529, 4998452, 4026540, 4098358, 4620256, 4627999, 4813542, 4985859, 4072508, 4498128, 4620257, 4755333, 4860528, and 4985861. The product UDI is 00885825006884.
If you have this product, contact your healthcare facility or Stryker Sustainability Solutions for instructions on handling and return.
The recalled product
- Product
- Daig Livewire Steerable, Product Number 401582; REPROCESSED ELECTROPHYSIOLOGY CATHETER
- Manufacturer
- Stryker Sustainability Solutions
- Hazard
- sterile-seal-failure
- infection-risk
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)
- UDI 00885825006884
- Lot Numbers: 3002664
- 4092049
- 4580888
- 4627994
- 4778840
- 4860529
- 4998452
- 4026540
- 4098358
- 4620256
- 4627999
- 4813542
- 4985859
- 4072508
- 4498128
- 4620257
- 4755333
- 4860528
- 4985861.
Distribution
Distributed nationwide across the United States.