Stryker Recalls Reprocessed Diagnostic EP Catheters Due to Item Number Error
Stryker Sustainability Solutions is recalling two reprocessed diagnostic EP catheters because they were identified as item # D134903 but are actually item # D134909, which is not approved for reprocessing.
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 hazard involves the use of a device not approved for reprocessing, which is a significant quality and safety concern, but the source text does not report any specific injuries, illnesses, or deaths, placing it in the Moderate category rather than High or Severe.
Plain-English summary
Stryker Sustainability Solutions is recalling two units of LASSO NAV eco Reprocessed Diagnostic EP Catheters. These medical devices are designed to obtain electrophysiological mapping of the cardiac structures of the heart.
The recall was initiated because the catheters were identified and distributed as item # D134903. It was subsequently determined that these specific catheters are actually item # D134909. Item # D134909 is not approved for reprocessing by Stryker’s Sustainability Solutions Division, meaning the company does not create or possess labeling for this item and did not receive labeling from the manufacturer.
The affected units were distributed in Kansas, United States. No other countries were affected. Consumers and healthcare providers should stop using these specific catheters and contact Stryker Sustainability Solutions for further instructions.
The recalled product
- Product
- Stryker Sustainability Solutions LASSO NAV eco Reprocessed Diagnostic EP Catheters designed to obtain electrophysiological mapping of the cardiac structures of the heart.
- Manufacturer
- Stryker Sustainability Solutions
- Affected units
- 2
Distribution
Distributed in 1 state:
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