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Terminated

BIB Balloon in Balloon Dilatation Catheter. Model Number: 420

FDA Recall Z-1754-2025 · Posted 2025-05-13

Recalling FirmNumed Inc
Recall StatusTerminated
Product CodeNVM
Date Initiated2025-04-21
Date Terminated2025-12-17
Product Quantity4 units

Reason for Recall

Balloon extension lumens are not printed correctly. Specifically, the inner balloon inflation hub was labeled as the outer balloon, and the outer balloon inflation hub was labeled as the inner balloon.

Firm Action

NuMED sent a "URGENT: MEDICAL DEVICE RECALL" letter dated 4/21/2025 via email on 4/21/2025 to their single customer. The customer was instructed to immediately return the affected units as soon as possible. If you have any questions or concerns, please contact Regulatory Affairs Manager at (315) 328-4491, or via email at [email protected].

Root Cause

Mixed-up of materials/components

Distribution Pattern

US distribution to Pennsylvania.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K050857BIB PTA BALLOON CATHETERNuMED, Inc. · 2005-07-28

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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