Summary
The FDA issued a Class II for BIB Balloon in Balloon Dilatation Catheter. Model Number: 420 by Numed Inc. Reason: Balloon extension lumens are not printed correctly. Specifically, the inner balloon inflation hub was labeled as the outer balloon, and the outer ball.
Details
Source
Device Recall
External ID
Z-1754-2025
Action Date
2025-05-21
Status
Terminated
Category
device
Product Description
BIB Balloon in Balloon Dilatation Catheter. Model Number: 420
Lot/Code Info: Model Number 420. UDI-DI: 04046964899768. Lot Numbers: BIB-16972 (Expiration date: 11/30/2028), BIB-16972-1 (Expiration date: 12/31/2028). Catheter Product Code: BB005.
Quantity Affected: 4 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.
Distribution
US distribution to Pennsylvania.
Type: Voluntary: Firm initiated
Recall Initiated: 2025-04-21
Company
Hopkinton, NY
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 152 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Numed Inc has 3 FDA actions in our database, including 1 recall and 2 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Numed Inc) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Numed Inc have FDA actions?
Numed Inc has 3 FDA actions in our database, including 1 recall and 2 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1754-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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