Summary
The FDA issued a Class II for Ventralight ST 4" x 6" Ellipse with Echo PS Catalog Number: 5955460 by Davol, Inc.. Reason: Balloon may not inflate as intended. If the balloon does not inflate during laparoscopic ventral hernia repair this may result in a delay or prolonga.
Details
Source
Device Recall
External ID
Z-2241-2023
Action Date
2023-08-02
Status
Ongoing
Category
device
Product Description
Ventralight ST 4" x 6" Ellipse with Echo PS Catalog Number: 5955460
Lot/Code Info: UDI-DI: (01)00801741031724(17)240428(10) Lot Numbers: HUGS0481 HUGS0549 HUGS1019 HUGS2031 HUGS2079 HUGT1627 HUGS2025 HUGT1989
Quantity Affected: 1188 units US; 5 units OUS
Reason for Recall
Balloon may not inflate as intended. If the balloon does not inflate during laparoscopic ventral hernia repair this may result in a delay or prolongation of the procedure, inadequate mesh placement, erosion/migration, pain and mesh infection
Distribution
Worldwide distribution - US Nationwide and the countries of Belgium, Czech Republic, France, Germany, Ireland, Italy, Netherlands, Portugal, Slovakia, South Africa, Spain, Sweden, Switzerland, UK, India, Hong Kong, Greece, Chile, and Colombia.
Type: Voluntary: Firm initiated
Recall Initiated: 2023-04-25
Company
Warwick, RI
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 191 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Davol, Inc. has 10 FDA actions in our database, including 8 recalls 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 (Davol, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Davol, Inc. have FDA actions?
Davol, Inc. has 10 FDA actions in our database, including 8 recalls and 2 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-2241-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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