Stryker Recalls Reprocessed EP Catheters Due to Navigation System Error
Stryker is recalling eight reprocessed electrophysiology catheters because an EEPROM chip error may occur when used with CARTO navigation systems.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II. The source text describes a potential software error code but does not report any illnesses, injuries, or deaths, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Stryker Sustainability Solutions is recalling eight units of Reprocessed BW Lasso 2515 NAV eco Variable Diagnostic EP Catheters (Ref D134302). The recall is due to a potential EEPROM chip error code that may occur when the catheters are used with CARTO EP Navigation Systems.
The affected devices are sterile, prescription-only electrophysiology catheters indicated for multiple electrode electrophysiological mapping of cardiac structures. The recall covers specific serial numbers: 2468846, 2468849, 2509029, 2489074, 2491174, 2500529, 2465989, and 2500528.
Distribution was made to medical facilities in Arizona, California, Connecticut, Florida, Georgia, Illinois, Kansas, Louisiana, Minnesota, Missouri, Ohio, Pennsylvania, Texas, Vermont, Washington, and Wisconsin, as well as to Canada. Medical facilities should stop using the affected devices and contact Stryker Sustainability Solutions for instructions on return or replacement.
The recalled product
- Product
- Stryker Sustainability Solutions Reprocessed BW Lasso 2515 NAV eco Variable Diagnostic EP Catheters, Ref D134302, Sterile, Rx. The Reprocessed 2515 NAV eco Variable Electrophysiology (EP) Catheters are indicated for multiple electrode electrophysiological mapping of the…
- Manufacturer
- Stryker Sustainability Solutions
- Hazard
- Affected units
- 8
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 (8)
- Serial numbers 2468846
- 2468849
- 2509029
- 2489074
- 2491174
- 2500529
- 2465989
- and 2500528
Distribution
Part of a larger recall action
This product is one of 2 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.
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