FDA recall Z-1754-2025

Product

BIB Balloon in Balloon Dilatation Catheter. Model Number: 420

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.

Key facts

Status

Terminated

Initiation date

2025-04-21

Report date

2025-05-21

Termination date

2025-12-17

Voluntary/Mandated

Voluntary: Firm initiated

Location

Hopkinton, NY, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1754-2025