Daig Livewire Steerable Reprocessed Electrophysiology Catheter Recall
Stryker Sustainability Solutions is recalling 458 units of Daig Livewire Steerable reprocessed electrophysiology catheters due to incomplete seals on the sterile product packaging.
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 involving a sterile medical device with potential for loss of sterility due to incomplete seals. Although no illnesses or injuries have been reported, the risk of contamination to a device intended for internal cardiac use presents a significant harm potential, meeting the High severity threshold.
Plain-English summary
Stryker Sustainability Solutions is recalling the Daig Livewire Steerable reprocessed electrophysiology catheter (Product Number 401932, UDI 00885825007355) in 458 units. The recall is due to incomplete seals on the sterile product packaging, which could compromise the sterility of the device.
The affected units were distributed nationwide in the United States and to Israel and Canada. The recall involves multiple lot numbers, including 4248065, 4625922, 4792899, 4880229, and many others.
Patients or healthcare providers who have received or are using these catheters should contact Stryker Sustainability Solutions for instructions on proper handling or replacement. Healthcare facilities should verify the lot numbers of any Daig Livewire Steerable catheters in inventory against the recall list to identify affected units.
The recalled product
- Product
- Daig Livewire Steerable, Product Number 401932; REPROCESSED ELECTROPHYSIOLOGY CATHETER
- Manufacturer
- Stryker Sustainability Solutions
- Affected units
- 458
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 00885825007355
- Lot Numbers: 4248065
- 4625922
- 4792899
- 4880229
- 4947722
- 4982083
- 5004927
- 5022043
- 5031874
- 5063926
- 4253253
- 4642049
- 4798611
- 4880230
- 4950352
- 4982089
- 5004930
- 5022044
- 5032223
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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