Z-0085-2027

Bard Ep Xt Decapolar Steerable, Diagnostic Ep Catheter, 6F, Large 4.0, 10, 2-5-2Mm, Ref: 201007

Name: Z-0085-2027 Bard Ep Xt Decapolar Steerable, Diagnostic Ep Catheter, 6F, Large 4.0, 10, 2-5-2Mm, Ref: 201007
Creator: Stryker Sustainability Solutions
Published: 2026-08-18
License: https://open.fda.gov/license/

Stryker Sustainability Solutions / initiated 2026-08-18 / Open, Classified

FDA source

Recall record

Recall number: Z-0085-2027
Status: Open, Classified
Initiated: 2026-08-18
Posted: 2026-10-05
Recalling firm: Stryker Sustainability Solutions
Product: Bard Ep Xt Decapolar Steerable, Diagnostic Ep Catheter, 6F, Large 4.0, 10, 2-5-2Mm, Ref: 201007
Product code: NLH Catheter, Recording, Electrode, Reprocessed
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 root cause: Packaging process control
Action: On 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 [email protected] Questions can be directed to the firm via email, [email protected], or via phone 800-624-4422.
Quantity in commerce: 10
Distribution: US Nationwide distribution in the state of NJ.
Product codes and lots: UDI-DI: 00885825003838. Lot: 5640704, Serial: 5097742, Distribution Date: May 26th 2026

Product code NLH

K030187Class IIReprocessed Electrophysiology CatheterAlliance Medical, Inc. / cleared 2003-09-24

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-10-09. View this recall on fda.gov (opens on fda.gov)