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Reprocessed DECANAV EP Catheter, D Curve

STERILMED, INC. · Model RR7D282CT · UDI-DI 10888551045698

NLH Prescription
1
510(k) clearances
474
Adverse events (1 deaths)
49
Recalls
12
Facilities

Description

Reprocessed DECANAV EP Catheter, D Curve, 7Fr, 115cm, Electrodes: 11, SP:2-8-2mm, Tip Length: 2.4mm, Pin Connector:34

Recalls

DateFirmReason
2026-08-18Stryker Sustainability SolutionsDiagnostic 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,
2026-05-15Medline Industries, LPExpansion of RES 98277. Specific lots of reprocessed catheters may contain small particles of residual material. If devices with residual particulates on patient-contacting surface
2026-04-10Stryker Sustainability SolutionsIncomplete seals on sterile product
2026-04-10Stryker Sustainability SolutionsIncomplete seals on sterile product
2026-04-10Stryker Sustainability SolutionsIncomplete seals on sterile product
2026-04-10Stryker Sustainability SolutionsIncomplete seals on sterile product
2026-04-10Stryker Sustainability SolutionsIncomplete seals on sterile product
2026-04-10Stryker Sustainability SolutionsIncomplete seals on sterile product
2026-04-10Stryker Sustainability SolutionsIncomplete seals on sterile product
2026-04-10Stryker Sustainability SolutionsIncomplete seals on sterile product

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.