Stryker Bard EP XT Decapolar Steerable Diagnostic EP Catheter Recalled for Sterile Barrier Breach
Stryker is recalling Bard EP XT Decapolar Steerable Diagnostic EP Catheters due to a potential sterile barrier breach that could lead to particulate embolization, infection, or thrombus formation.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II, and the source describes hazards including particulate embolization, infection, thrombus, or granuloma formation, which are serious adverse health consequences. The source does not report any illnesses, injuries, or deaths.
Plain-English summary
Stryker Sustainability Solutions is recalling Bard EP XT Decapolar Steerable, Diagnostic EP Catheters, 6F, Large 4.0, 10, 2-5-2MM, Reference 201007. The recall is due to a potential breach of the sterile barrier on the straight seal side of the primary pouch.
If the affected catheters are used, the breach could lead to particulate embolization, infection, thrombus, or granuloma formation from particulate matter. The source text does not report any illnesses, injuries, or deaths associated with this recall.
The affected units were distributed nationwide in the United States, specifically within the state of New Jersey. The specific lot number is 5640704, serial number 5097742, with a distribution date of May 26, 2026. The UDI-DI is 00885825003838. Healthcare providers and patients should check their inventory and records for these specific identifiers and contact Stryker for further instructions on handling or replacement of the devices.
The recalled product
- Product
- BARD EP XT DECAPOLAR STEERABLE, DIAGNOSTIC EP CATHETER, 6F, LARGE 4.0, 10, 2-5-2MM, REF: 201007
- Manufacturer
- Stryker Sustainability Solutions
- Category
- Medical Device — Catheter
- Affected units
- 10
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 (3)
- UDI-DI: 00885825003838. Lot: 5640704
- Serial: 5097742
- Distribution Date: May 26th 2026
Distribution
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