Daig Livewire Steerable Electrophysiology Catheters Recalled for Incomplete Seals
Stryker Sustainability Solutions is recalling Daig Livewire Steerable electrophysiology catheters with incomplete seals on sterile packaging. The defect may allow contamination of the sterile product.
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 manufacturing defect (incomplete seals) that could compromise sterility and result in patient harm through infection or contamination. Although no injuries have been reported in the source text, the risk-of-harm nature of a compromised sterile barrier in an invasive electrophysiology catheter justifies a High severity rating.
Plain-English summary
Stryker Sustainability Solutions is recalling Daig Livewire Steerable, Product Number 401603, reprocessed electrophysiology catheters distributed nationwide in the US and in Israel and Canada. The recall involves 9 units across lot numbers 3978113, 4465650, 4468623, 4594989, 4622932, 4622934, 4629627, 4665006, and 4720693 (UDI 00885825006969).
The reason for this recall is incomplete seals on the sterile product packaging. Incomplete seals may compromise the sterile barrier and allow contamination of the device.
Patients or healthcare facilities that have received this product should contact Stryker Sustainability Solutions or their healthcare provider for guidance on whether the product should be used. Any adverse events or injuries related to this device should be reported to the FDA MedWatch program.
The recalled product
- Product
- Daig Livewire Steerable, Product Number 401603, REPROCESSED ELECTROPHYSIOLOGY CATHETER
- Manufacturer
- Stryker Sustainability Solutions
- Hazard
- sterility-compromise
- contamination
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 (10)
- UDI 00885825006969
- Lot Numbers: 3978113
- 4465650
- 4468623
- 4594989
- 4622932
- 4622934
- 4629627
- 4665006
- 4720693.
Distribution
Distributed nationwide across the United States.