Agency classClass IOur severity:Critical FDA (Devices)·Z-1116-2019·Announced 2019-05-01

Edwards Lifesciences Recalls Fogarty Dilation Atrioseptostomy Catheters

Edwards Lifesciences is recalling Fogarty Dilation Atrioseptostomy Catheters due to reports of balloon fragmentation or detachment and difficulty deflating the balloon after deployment.

The agency’s classification

FDA (Devices): Class I

Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 5/5 (Critical).

Highest-severity recall. The hazard can cause serious injury or death. Stop using the product now and follow the agency's instructions.

Our severity reasoning: The source metadata explicitly identifies the agency classification as 'Class I'. According to the severity rubric, an FDA Class I recall mandates a score of 5 (Critical) regardless of other factors.

Plain-English summary

Edwards Lifesciences, LLC is recalling 1,093 units of the Fogarty Dilation Atrioseptostomy Catheter, Sterile EO, Rx Only (REF: 830705F). The recall covers all lots with an expiration date within 15 months from March 1, 2019. The product is distributed worldwide, including nationwide in the United States and in numerous foreign countries.

The recall is being issued due to reports of difficulty with balloon deflation after deployment, as well as reports of balloon fragmentation or detachment. The Fogarty dilation atrioseptostomy catheter is designed for enlarging interatrial openings and is used in pediatric cardiology for the palliation of several congenital cardiac defects.

Healthcare providers and patients should stop using the affected catheters and contact Edwards Lifesciences for further instructions or a replacement. The recall is classified as Class I by the FDA, indicating a reasonable probability that the use of or exposure to the violative product will cause serious adverse health consequences or death.

The recalled product

Product: Edwards Lifesciences, Fogarty Dilation Atrioseptostomy Catheter, Sterile EO, Rx Only, REF: 830705F Product Usage: The Fogarty dilation atrioseptostomy catheter is designed for enlarging interatrial openings. In most pediatric cardiology centers, balloon atrioseptostomy is an…
Manufacturer: Edwards Lifesciences, LLC
Category: Medical Device — Cardiac Catheter
Hazard: balloon-fragmentation
balloon-detachment
device-malfunction
Affected units: 1,093

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

All lots within 15 months expiry from 03/01/2019

Distribution

Distributed nationwide across the United States.

The notice also names 33 states specifically:

Part of a larger recall action

This product is one of 2 recalled by Edwards Lifesciences, LLC under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

Same manufacturer · Edwards Lifesciences, LLC

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Same hazard · balloon fragmentation