WRAPSODY® (REF WRAP-L12060)Recalls & reported problems

Merit Medical Systems, Inc. · Class 3 · Implant

Adverse event reports: 3
Deaths reported: 0
Injuries reported: 3
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00884450845646), received between Sep 22, 2026 and Sep 30, 2026 — classified as 3 injuries.

The most frequently reported specific device problem is “Patient Device Interaction Problem” (2 reports).

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

Patient Device Interaction Problem2
Adverse Event Without Identified Device or Use Problem1

Patient problems

Thrombosis/Thrombus2
Unintended Loss of Vascular Access2
Ischemia1
Medical device site infection1

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

InjurySep 30, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Ischemia; Medical device site infection
MAUDE report 50947122 ↗
InjurySep 22, 2026Patient Device Interaction Problem
Patient problems: Thrombosis/Thrombus; Unintended Loss of Vascular Access
MAUDE report 50855707 ↗
InjurySep 22, 2026Patient Device Interaction Problem
Documentation of a Merit WRAPSODY clinical trial was received, the patient experienced thrombosis on the graft. They were treated with medication, intervention and a thrombectomy. Possibly related to the subject device.
Patient problems: Thrombosis/Thrombus; Unintended Loss of Vascular Access
MAUDE report 50854137 ↗

Device details

UDI-DI	`00884450845646`
Brand	WRAPSODY®
Model	A
Catalog no.	WRAP-L12060
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	Mar 12, 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.

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

COVERA AVSM10060
Angiomed GmbH & Co. Medizintechnik KG · System, endovascular graft, arteriovenous (AV) dialysis access circuit stenosis treatment
1 recall33 reports
COVERA AVSM08060
Angiomed GmbH & Co. Medizintechnik KG · System, endovascular graft, arteriovenous (AV) dialysis access circuit stenosis treatment
1 recall21 reports
COVERA AVSM09060
Angiomed GmbH & Co. Medizintechnik KG · System, endovascular graft, arteriovenous (AV) dialysis access circuit stenosis treatment
1 recall18 reports
COVERA AVSM10080
Angiomed GmbH & Co. Medizintechnik KG · System, endovascular graft, arteriovenous (AV) dialysis access circuit stenosis treatment
1 recall16 reports
COVERA AVSM10040
Angiomed GmbH & Co. Medizintechnik KG · System, endovascular graft, arteriovenous (AV) dialysis access circuit stenosis treatment
1 recall15 reports
COVERA AVFM10060
Angiomed GmbH & Co. Medizintechnik KG · System, endovascular graft, arteriovenous (AV) dialysis access circuit stenosis treatment
1 recall14 reports
COVERA AVSM09080
Angiomed GmbH & Co. Medizintechnik KG · System, endovascular graft, arteriovenous (AV) dialysis access circuit stenosis treatment
1 recall1 death14 reports
COVERA AVSM10100
Angiomed GmbH & Co. Medizintechnik KG · System, endovascular graft, arteriovenous (AV) dialysis access circuit stenosis treatment
1 recall13 reports

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

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.