Stryker Sustainability Solutions: Catheter, Recording, Electrode, Reprocessed
Recall Summary Stryker Sustainability Solutions is recalling reprocessed BARD EP XT DECAPOLAR STEERABLE diagnostic catheters (Model 201007) distributed nationwide because the sterile packaging may have a breach that could allow particles to enter the device. If used, these contaminated catheters could cause blood clots, infections, or other complications from particulate matter entering the bloodstream. Healthcare facilities that received these devices should identify and quarantine affected units.
- Recalling firm
- Stryker Sustainability Solutions
- Product
- BARD EP XT DECAPOLAR STEERABLE, DIAGNOSTIC EP CATHETER, 6F, LARGE 4.0, 10, 2-5-2MM, REF: 201007
- Reason
- Diagnostic electrophysiology (EP) catheter may have a breached sterile barrier on the straight seal side of the primary pouch, which if used could lead to particulate embolization, infection, thrombus or ganuloma formation from particulate matter.
- Classification
- Class II
- Category
- medical device recall
- Country
- United States
- Agency
- FDA-DEVICES
- Recall date
- 2026-08-18
- Status
- Open, Classified
- Areas affected
- AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...
- Distribution
- US Nationwide distribution in the state of NJ.
Official recall notice from FDA-DEVICES
Recall details on Nibble Recalls: https://trynibble.app/recalls/ddf01c0b-05f2-4237-9e0d-9f7f92ff3cd8