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U.S. Department of Health and Human Services

Class 2 Device Recall BARD EP XT DECAPOLAR STEERABLE, DIAGNOSTIC EP CATHETER

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 Class 2 Device Recall BARD EP XT DECAPOLAR STEERABLE, DIAGNOSTIC EP CATHETERsee related information
Date Initiated by FirmAugust 18, 2026
Date PostedOctober 05, 2026
Recall Status1 Open3, Classified
Recall NumberZ-0085-2027
Recall Event ID 99655
510(K)NumberK030187 
Product Classification Catheter, recording, electrode, reprocessed - Product Code NLH
ProductBARD EP XT DECAPOLAR STEERABLE, DIAGNOSTIC EP CATHETER, 6F, LARGE 4.0, 10, 2-5-2MM, REF: 201007
Code Information UDI-DI: 00885825003838. Lot: 5640704, Serial: 5097742, Distribution Date: May 26th 2026
FEI Number 3009350690
Recalling Firm/
Manufacturer		 Stryker Sustainability Solutions
1810 W Drake Dr
Tempe AZ 85283-4327
For Additional Information Contact
888-888-3433
Manufacturer Reason
for Recall		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.
FDA Determined
Cause 2		Packaging process control
ActionOn 8/18/2026, the recall notice was mailed to the customer asking them to do the following: 1) Inform individuals within your organization who need to be aware of this action. 2) Quarantine and return affected product to the firm. 4) Complete and return the Business Reply Form via email to SSSPFA@stryker.com Questions can be directed to the firm via email, SSSPFA@stryker.com, or via phone 800-624-4422.
Quantity in Commerce10
DistributionUS Nationwide distribution in the state of NJ.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = NLH
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