Drug recall
BARD EP XT DECAPOLAR STEERABLE, DIAGNOSTIC EP CATHETER, 6F, LARGE 4.0, 10, 2-5-2MM, REF: 201007
FDA recall event 99655 · Class II · Stryker Sustainability Solutions
Key facts
| Event ID | 99655 |
|---|---|
| Recall numbers | Z-0085-2027 |
| Recalling firm | Stryker Sustainability Solutions |
| Product type | Devices |
| Products | BARD EP XT DECAPOLAR STEERABLE, DIAGNOSTIC EP CATHETER, 6F, LARGE 4.0, 10, 2-5-2MM, REF: 201007 |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Firm Initiated |
| 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… |
| Initiation date | Aug 18, 2026 |
| Report date | Oct 14, 2026 |
| City | Tempe |
| State | AZ |
| Country | United States |
| FEI number | 3009350690 |
At a glance
- 1–9 Products in this recall
- 1–9 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: