Stryker Recalls Reprocessed Coronary Sinus Diagnostic Catheters
Stryker Sustainability Solutions is recalling 2,722 reprocessed Coronary Sinus Diagnostic EP Catheters because thrombogenicity tests showed they did not meet non-thrombogenic specifications.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device with a failure to meet non-thrombogenic specifications, which poses a risk of harm (thrombosis) even though no injuries are reported, fitting the 'High' severity criteria for risk-of-harm products.
Plain-English summary
Stryker Sustainability Solutions is recalling 2,722 units of the Coronary Sinus (CS) Uni-Directional Diagnostic Electrophysiology (EP) Catheter, catalog numbers D135303 and D135304. These reprocessed catheters are indicated for electrophysiological mapping of cardiac structures, specifically for stimulation and recording in the coronary sinus.
The recall was initiated because thrombogenicity test results demonstrated that both the test devices and control devices did not meet the internal specification of being non-thrombogenic. The affected units were distributed worldwide, including US Nationwide and Canada.
Healthcare providers should stop using the affected catheters and contact Stryker Sustainability Solutions for further instructions. The source text does not report any specific illnesses or injuries associated with this recall.
The recalled product
- Product
- Coronary Sinus (CS) Uni-Directional Diagnostic Electrophysiology (EP) Catheter, catalog numbers D135303 and D135304. Product Usage: The Reprocessed CS Diagnostic EP Catheter is indicated for electrophysiological mapping of cardiac structures; i.e., stimulation and recording…
- Manufacturer
- Stryker Sustainability Solutions
- Hazard
- Affected units
- 2,722
Distribution
Distributed nationwide across the United States.
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