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.
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 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
- Affected units
- 319
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.
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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Same hazard · sterility compromise
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- HighMedline Myringotomy Kits Recalled for Potential Sterility Compromise
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Similar recalls
- ModerateStryker Recalls Mislabeled Reprocessed Diagnostic Electrophysiology Catheters
FDA (Devices) · 2016-06-01
- HighStryker Recalls Reprocessed Diagnostic Electrophysiology Catheters and Cables
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- ModerateStryker Recalls Reprocessed Diagnostic Electrophysiology Catheters Due to Mislabeled French Size
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- HighStryker Recalls Reprocessed Electrophysiology Catheter Cables Due to Sterility Breach
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- HighStryker Diagnostic Electrophysiology Catheters Recalled for Testing Failure
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- CriticalReprocessed steerable electrophysiology catheters recalled over residual particulates on surfaces
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