Reprocessed Electrophysiology Catheter with Incomplete Sterile Seals Recalled
Stryker Sustainability Solutions is recalling Daig Livewire Steerable reprocessed electrophysiology catheters due to incomplete seals on the sterile product, which may compromise sterility.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: This is an FDA Class II recall of a sterile medical device (electrophysiology catheter) with compromised sterility due to incomplete seals. Breach of sterility in a device used in an invasive cardiac procedure presents significant risk of infection and harm, meeting the Severe classification criterion.
Plain-English summary
Stryker Sustainability Solutions is recalling Daig Livewire Steerable, Product Number 401923, reprocessed electrophysiology catheters. The recalled units have incomplete seals on the sterile product, which could compromise the sterility of the device.
The affected units were distributed in the United States, Israel, and Canada. The recall involves three specific lot numbers: 3557411, 3702628, and 4498116. Affected devices carry UDI 00885825007331.
Patients who have received this device should consult their healthcare provider. Healthcare facilities should identify and quarantine affected units and consider returning them to Stryker Sustainability Solutions.
The recalled product
- Product
- Daig Livewire Steerable, Product Number 401923; REPROCESSED ELECTROPHYSIOLOGY CATHETER
- Manufacturer
- Stryker Sustainability Solutions
- Affected units
- 3
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 00885825007331. Lot Numbers: 3557411
- 3702628
- 4498116.
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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