Daig Livewire Steerable Electrophysiology Catheter Incomplete Seals Recall
Stryker Sustainability Solutions is recalling Daig Livewire Steerable reprocessed electrophysiology catheters (Product Number 401904) due to incomplete seals on sterile product. The recall affects 1,352 units distributed across the United States, Israel, and Canada.
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: This is an FDA Class II recall of a sterile medical device with a compromised sterile barrier (incomplete seals), which presents a risk of harm (contamination and potential infection) to patients. No reported illnesses or injuries are stated in the source, but the hazard is significant for a sterile implantable/invasive device used in electrophysiology procedures.
Plain-English summary
Stryker Sustainability Solutions is recalling the Daig Livewire Steerable reprocessed electrophysiology catheter (Product Number 401904, UDI 00885825007263) due to incomplete seals on the sterile product. Approximately 1,352 units have been distributed in the United States and internationally to Israel and Canada.
The affected product includes multiple lot numbers ranging from 3016810 through 5087325. Patients and healthcare facilities currently possessing affected units should discontinue use and contact the manufacturer for instructions regarding replacement or return.
The incomplete seals compromise the sterile barrier of the product, which may allow contamination and create a potential safety risk during use. Healthcare providers should verify their inventory against the provided lot numbers and take appropriate action with affected units.
For more information or to report any adverse events, contact Stryker Sustainability Solutions or notify the FDA.
The recalled product
- Product
- Daig Livewire Steerable, Product Number 401904; REPROCESSED ELECTROPHYSIOLOGY CATHETER
- Manufacturer
- Stryker Sustainability Solutions
- Affected units
- 1,352
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 00885825007263
- Lot Numbers: 3016810
- 4488621
- 4592565
- 4801485
- 4882673
- 4967856
- 4993019
- 5004980
- 5043929
- 5071232
- 3481897
- 4488631
- 4592566
- 4802770
- 4882750
- 4967857
- 4993023
- 5005187
- 5043930
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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