Stryker Recalls Reprocessed Diagnostic Electrophysiology Catheters Due to Chip Error
Stryker is recalling 103 reprocessed diagnostic 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 technical error code but does not report any hospitalizations, injuries, or deaths, aligning with the criteria for a moderate severity score.
Plain-English summary
Stryker Sustainability Solutions is recalling 103 units of the BW Lasso 2515 ANV eco Variable Diagnostic EP Catheter (REF D134301). These diagnostic electrophysiology catheters are designed to transmit electrical impulses and are positioned for endocardial recording or stimulation.
The recall was initiated after Stryker received an increase in reports indicating that an EEPROM chip error code may occur when the reprocessed catheters are used with CARTO(R) EP Navigation Systems.
The affected units were distributed in the United States to Georgia, Kansas, Missouri, Florida, California, Washington, and Iowa, as well as internationally to Germany, Japan, and Canada. Specific lot codes for the recalled units are listed in the official recall documentation.
The recalled product
- Product
- BW Lasso 2515 ANV eco Variable Diagnostic EP Catheter, REF D134301 Diagnostic electrophysiology (EP) catheters are specially designed electrode catheters that transmit electrical impulses and can be positioned for endocardial recording or stimulation.
- Manufacturer
- Stryker Sustainability Solutions
- Hazard
- Affected units
- 103
Distribution
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