Reprocessed Electrophysiology Catheters Recalled for Incomplete Seals
Stryker Sustainability Solutions is recalling Daig Livewire Steerable reprocessed electrophysiology catheters due to incomplete seals on sterile product packaging, which could compromise sterility and patient safety.
What this means for you
Illness, injury, or structural failure has been reported. 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 a packaging defect that compromises sterility. The potential for patient harm from loss of sterility of an invasive device, combined with the Class II designation and significant unit quantity, meets the threshold for Severe severity.
Plain-English summary
Stryker Sustainability Solutions is recalling Daig Livewire Steerable reprocessed electrophysiology catheters, Product Number 401575 (UDI 00885825006815), due to incomplete seals on sterile product packaging. The recall affects 319 units distributed nationwide in the United States and to Israel and Canada.
Incomplete seals on the sterile packaging may compromise the sterility of the device, which could result in patient harm if the product is used in its current condition.
Patients and healthcare providers who have received or are using affected devices should stop use immediately. Affected lot numbers are listed in this recall notice. Healthcare facilities should check their inventories and quarantine any affected units. Consumers and providers should contact Stryker Sustainability Solutions with questions or to report any related adverse events.
The recalled product
- Product
- Daig Livewire Steerable, Product Number 401575; REPROCESSED ELECTROPHYSIOLOGY CATHETER
- Manufacturer
- Stryker Sustainability Solutions
- Hazard
- sterility-compromise
- incomplete-seal
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 00885825006815
- Lot Numbers: 2696145
- 3794476
- 4262195
- 4633829
- 4786916
- 4849947
- 5002352
- 2965551
- 3812493
- 4265992
- 4637189
- 4792723
- 4850691
- 5002356
- 3152561
- 3814730
- 4299204
- 4637394
- 4792893
Distribution
Distributed nationwide across the United States.