Daig Livewire Steerable Reprocessed Electrophysiology Catheters Recalled
Stryker Sustainability Solutions is recalling Daig Livewire Steerable reprocessed electrophysiology catheters due to incomplete seals on sterile product packaging. The defect 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 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 risk of harm (loss of sterility in a device intended for invasive use). The source text does not report any illnesses or injuries; the hazard is potential rather than realized, making this a High severity case per the rubric criterion for risk-of-harm products without reported injury.
Plain-English summary
Stryker Sustainability Solutions is recalling Daig Livewire Steerable reprocessed electrophysiology catheters (Product Number 401914) due to incomplete seals on sterile product packaging. The affected catheters were distributed nationwide in the United States and to Israel and Canada.
The incomplete seals on the sterile packaging may allow the product to become non-sterile, potentially compromising patient safety during use. Affected lot numbers are 3293805, 4060170, 4533158, 4613654, 4678077, 4846998, 4973532, 4976226, 5005455, and 5056648. The product is identified by UDI 00885825007294.
Healthcare providers and patients who have these catheters should stop using them and contact Stryker Sustainability Solutions for instructions on return or replacement. Patients who have already received treatment with affected catheters should consult their healthcare provider with any concerns.
The recalled product
- Product
- Daig Livewire Steerable, Product Number 401914; REPROCESSED ELECTROPHYSIOLOGY CATHETER
- Manufacturer
- Stryker Sustainability Solutions
- Affected units
- 10
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 (11)
- UDI 00885825007294
- Lot Numbers: 3293805
- 4060170
- 4533158
- 4613654
- 4678077
- 4846998
- 4973532
- 4976226
- 5005455
- 5056648.
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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