Daig Livewire Steerable Electrophysiology Catheter Sterile Seal Defect Recall
Stryker Sustainability Solutions is recalling three lots of Daig Livewire Steerable reprocessed electrophysiology catheters due to incomplete seals on the sterile packaging. The defect affects units distributed 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 recall of a sterile medical device with a defect (incomplete seal) that could compromise sterility and create a risk of contamination-related harm. No illnesses or injuries have been reported, making it ineligible for the Severe (4) category, but the potential for patient harm from a compromised sterile barrier justifies a High (3) rating.
Plain-English summary
Stryker Sustainability Solutions is recalling Daig Livewire Steerable reprocessed electrophysiology catheters, Product Number 401908, due to incomplete seals on the sterile product packaging. Three units with lot numbers 3459566, 3623281, and 4191726 (UDI 00885825007287) have been identified as affected.
The incomplete seals may compromise the sterility of the device, potentially exposing patients to contamination during use. These catheters are intended for electrophysiology procedures where sterility is critical.
The affected products were distributed nationwide in the United States, as well as in Israel and Canada. Patients and healthcare providers who have received or used these catheters should contact Stryker Sustainability Solutions or their healthcare provider if they have questions or concerns about their use.
The recalled product
- Product
- Daig Livewire Steerable, Product Number 401908; REPROCESSED ELECTROPHYSIOLOGY CATHETER
- Manufacturer
- Stryker Sustainability Solutions
- Hazard
- sterile-seal-defect
- contamination-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 (4)
- UDI 00885825007287
- Lot Numbers: 3459566
- 3623281
- 4191726.
Distribution
Distributed nationwide across the United States.