Z-1754-2025Class II

BIB Balloon in Balloon Dilatation Catheter. Model Number: 420

Name: Z-1754-2025 BIB Balloon in Balloon Dilatation Catheter. Model Number: 420
Creator: Numed Inc
Published: 2025-04-21
License: https://open.fda.gov/license/

Numed Inc / initiated 2025-04-21 / Terminated / root cause: labeling and UDI

FDA source

Numed Inc began a recall of BIB Balloon in Balloon Dilatation Catheter. Model Number: 420 on 2025-04-21. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1754-2025
Classification: Class II
Status: Terminated
Initiated: 2025-04-21
Posted: 2025-05-13
Terminated: 2025-12-17
Recalling firm: Numed Inc
Product: BIB Balloon in Balloon Dilatation Catheter. Model Number: 420
Product code: NVM Catheter, Angioplasty, Peripheral, Transluminal, Dual-Balloon
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.
Root cause tag: labeling and UDI
FDA root cause: Mixed-up of materials/components
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].
Quantity in commerce: 4 units
Distribution: US distribution to Pennsylvania.
Product codes and lots: 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.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1754-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1754-2025	Class II	Terminated	Voluntary: Firm initiated	2025-05-21	2025-05-13

Product code NVM

K050857Class IIBib Pta Balloon CatheterNuMED, Inc. / cleared 2005-07-28

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)