Recall Z-2038-2024— Covidien, LLC

Name: FDA recall Z-2038-2024
Creator: U.S. Food and Drug Administration
Published: 2024-04-25

Class II · Ongoing

Class II FDA medical device recall by Covidien, LLC, initiated 2024-04-25. It names one FDA 510(k) clearance: K132337. Product: EsoFLIP, 30mm BALLOON DILATION CATHETER, REF ES-330, Rx Only. Reason: Due to saline conductivity issues, their is a potential that dilation catheters may provide inaccurate esophageal diameter measurements that may lead to various harms..

Recalling firm: Covidien, LLC
Classification: Class II
Status: Ongoing
Initiated: 2024-04-25
Firm location: Santa Clara, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K132337 — ESOFLIP BALLOON DILATION CATHETERCrospon, Ltd.·cleared 2013-10-07

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

EsoFLIP, 30mm BALLOON DILATION CATHETER, REF ES-330, Rx Only

Reason for recall

Due to saline conductivity issues, their is a potential that dilation catheters may provide inaccurate esophageal diameter measurements that may lead to various harms.

Data sourced from openFDA. This site is unofficial and independent of the FDA.