Stryker Recalls Reprocessed Diagnostic Electrophysiology Catheters and Cables
Stryker Sustainability Solutions is recalling 46 reprocessed diagnostic electrophysiology catheters and cables due to a potential sterility breach in the package seal.
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 potential sterility breach in a medical device, which poses a risk of harm (infection) even though no injuries have been reported. This aligns with the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Stryker Sustainability Solutions is recalling 46 units of Reprocessed Diagnostic Electrophysiology (EP) Catheters and Diagnostic EP Catheter Cables. The recall is due to a potential sterility breach in the package seal. The affected model numbers include D6-DR-252-RT, F6-QF-252RT, 201101, 201104, 401442, 401860, D7-A20-131-RT, 401661, 401972, 401977, 401981, 401982, C6-MR/MST4-SA, and CB3434CT.
These devices are indicated for temporary intracardiac sensing, recording, stimulation, and electrophysiological mapping of cardiac structures. The recall covers units distributed in Arizona, California, and Ohio. The source text does not report any illnesses or injuries associated with this recall.
Healthcare facilities should stop using the affected devices and contact Stryker Sustainability Solutions for further instructions. The recall is classified as Class II by the FDA.
The recalled product
- Product
- Reprocessed Diagnostic Electrophysiology (EP) Catheters and Diagnostic EP Catheter Cables, Model Numbers: D6-DR-252-RT, F6-QF-252RT, 201101, 201104, 401442, 401860, D7-A20-131-RT, 401661, 401972, 401977, 401981, 401982, C6-MR/MST4-SA, CB3434CT. Product Usage: Reprocessed…
- Manufacturer
- Stryker Sustainability Solutions
- Affected units
- 46
Distribution
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