WRAPSODY® (REF WRAP-L12080)Recalls & reported problems

Merit Medical Systems, Inc. · Class 3 · Implant

Data updated Oct 13, 2026 from official FDA records · Editorial policy

Adverse event reports: 1
Deaths reported: 0
Injuries reported: 1
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00884450845660), received between Apr 22, 2025 and Apr 22, 2025 — classified as 1 injury.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (1 report).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Reports received per month

Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

Detachment of Device or Device Component1
Fracture1
Material Separation1

Patient problems

No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

InjuryApr 22, 2025Fracture; Material Separation; Detachment of Device or Device Component; Fracture; Material Separation; Detachment of Device or Device Component
THE ACCOUNT ALLEGES THAT THE STENT GRAFT WAS DEPLOYED WITHIN THE CEPHALIC VEIN, BUT THE DEPLOYMENT SYSTEM COULD NOT BE REMOVED FROM THE PATIENT. PART OF THE DELIVERY SYSTEM DETACHED WITHIN THE PATIENT. A VASCULAR SNARE WAS USED TO RETRIEVE THE FOREIGN BODY, DELAYING THE PROCEDURE. THE PROCEDURE WAS NOT COMPLETED SUCCESSFULLY FOR THIS PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21886824 ↗

Device details

UDI-DI	`00884450845660`
Brand	WRAPSODY®
Model	A
Catalog no.	WRAP-L12080
Company	Merit Medical Systems, Inc.
Product code	PFV · System, endovascular graft, arteriovenous (AV) dialysis access circuit stenosis treatment
Class	Class 3
FDA submission	None listed
Implant	Yes
Rx / OTC	Prescription
Single use	Yes
Sterile	Yes
MRI safety	Labeling does not contain MRI Safety Information
Status	In Commercial Distribution
Record updated	Apr 28, 2025

Device type (GMDN): Central/peripheral venous endovascular stent-graft

A non-bioabsorbable tubular device designed to be implanted in a central and/or peripheral vein (e.g., subclavian, brachiocephalic) to maintain vessel lumen patency, typically to treat stenosis in the outflow of an arteriovenous fistula (AVF) or graft used for haemodialysis; it is not intended for coronary or intracranial venous stenting. It is a mesh structure made of metal [e.g., nickel-titanium alloy] that is covered with a synthetic polymer [e.g., polytetrafluoroethylene (ePTFE)] membrane (endovascular graft), and contains an inner carbon coating to help prevent platelet adhesion. It is typically expanded in situ and disposable devices associated with implantation may be included.

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All System, endovascular graft, arteriovenous (AV) dialysis access circuit stenosis treatment devices →

Sources and updates

Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
Adverse event reports: FDA MAUDE, file dated Oct 13, 2026 · each report above links to its original FDA record
Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.

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