WRAPSODY® (REF WRAP-L08100)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: 0
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00884450845493), received between Aug 21, 2025 and Aug 21, 2025 — classified as 1 malfunction.

The most frequently reported specific device problem is “Fracture” (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

Fracture1

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.

MalfunctionAug 21, 2025Fracture; Fracture
DURING DEPLOYMENT OF THE STENT, THE WHITE PLASTIC COMPONENT AT THE DISTAL END OF THE APPLICATION DEVICE DETACHED FROM THE APPLICATION DEVICE. A SNARE WAS USED TO SUCCESSFULLY REMOVE THE COMPNENT. NO INJURY TO THE PATIENT WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22868730 ↗

Device details

UDI-DI	`00884450845493`
Brand	WRAPSODY®
Model	A
Catalog no.	WRAP-L08100
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	Jan 15, 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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