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Assure Wearable Cardioverter Defibrillator: medical device reports filed with FDA

1,118 reports name it, 2023–2026. Manufacturer given most often on reports: Kestra Medical Technologies. Product code MVK.

Read first · FDA's statement on these data

Adverse event reports submitted to FDA do not undergo extensive validation or verification. Therefore, a causal relationship cannot be established between product and reactions listed in a report. While a suspected relationship may exist, it is not medically validated and should not be the sole source of information for clinical decision making or other assumptions about the safety or efficacy of a product. Additionally, it is important to remember that adverse event reports represent a small percentage of total usage numbers of a product. Common products may have a higher number of adverse events due to the higher total number of people using the product. openFDA, FDA

FDA adds: "Although MDRs are a valuable source of information, this passive surveillance system has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data. In addition, the incidence or prevalence of an event cannot be determined from this reporting system alone due to potential under-reporting of events and lack of information about frequency of device use." And: "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices."

Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated.

Not medical advice. This site counts what was reported to FDA. Questions about a medicine or device belong with a pharmacist or clinician.

1,118
device reports naming the brand: 0% of all MAUDE reports · about 420 a year; 730
reports, 12 months to August 2026: 146 in the 12 months before; 96.2%
classified as malfunction: 73.1% across the product code; 3.5%
classified as death, as reported: 39 reports · not verified by FDA

FDA's MAUDE database holds 1,118 reports that name the brand "Assure Wearable Cardioverter Defibrillator" (wearable automated external defibrillator), received between November 2023 and August 2026; the manufacturer given most often on reports is Kestra Medical Technologies. Spellings of one product vary from report to report.

730 reports arrived in the 12 months to August 2026, up 400% from 146 in the 12 months before. FDA releases MAUDE data monthly; reports can arrive months after an event, so the newest months grow in later releases. The event types recorded are malfunction (96.2%), death (3.5%) and injury (0.4%); across all wearable automated external defibrillator reports (product code MVK) death is recorded in 2.5% and malfunction in 73.1%. Event type is the reporter's classification of the report, not a verified outcome.

The device problems coded most often are electrical /electronic property problem (46.2%), inappropriate/inadequate shock/stimulation (39.7%) and failure to power up (10.1%). The patient problems coded most often are shock from patient lead(s), heart failure/congestive heart failure and asystole. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data."

Reports by month, five years

Reports by the month FDA received them. FDA releases MAUDE data monthly; reports can arrive months after an event, so the newest months grow in later releases.

By year received

Event type and report source

Event type, as classified on the report

Death3.5%39

Injury0.4%4

Malfunction96.2%1,075

Other0%0

Not given0%0

Who filed the report

Manufacturer report99.9%1,117

Voluntary report0.1%1

User facility report0%0

Distributor report0%0

Not given0%0

Grey bar: all 149,799 reports carrying product code MVK. Event type is the filer's classification and is not verified by FDA.

Device problems coded

Device problem (FDA code)	Reports	Share	Share across product code
Electrical /electronic property probleman electrical or electronic problem	516	46.2%	0.7%
Inappropriate/inadequate shock/stimulation	444	39.7%	9.1%
Failure to power up	113	10.1%	10.1%
Failure to charge	7	0.6%	2.8%
Connection problema connection problem	2	0.2%	0.4%
Display or visual feedback problem	1	0.1%	1.5%
Insufficient device problem information	1	0.1%	1.1%
Material integrity problema problem with the device material	1	0.1%	0%

FDA's device problem codes as entered on the report; one report can carry several. Generic codes such as "no apparent adverse event" are left out.

Patient problems coded

Patient problem (FDA code)	Reports	Share
Shock from patient lead(s)	70	6.3%
Heart failure/congestive heart failure	8	0.7%
Asystole	7	0.6%
Arrhythmia	3	0.3%
Atrial flutter	1	0.1%
Bradycardiaslow heart rate	1	0.1%
Cardiac arrestthe heart stopped	1	0.1%
Dyspneashortness of breath	1	0.1%

Patient problem codes are present mainly in reports filed since 2019 and are often blank.

In context

Measure	Assure Wearable Cardioverter Defibrillator	Product code MVK	All MAUDE reports
Reports	1,118	149,799	26,136,888
Share of that pool	—	0.7%	0%
Classified as death, per 1,000 reports	35	25	9
Classified as injury	0.4%	24.4%	36.2%
Classified as malfunction	96.2%	73.1%	62.3%
Filed by the manufacturer	99.9%	100%	94.9%

Shares are of reports, not of devices in use. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data."

Other brands with product code MVK

Brand	Reports	Latest 12 months	Classified as death
LifeVest WCD 4000 System	140,785	10,693	2.5%
Lifevest Wcd 3000 System	4,109	0	1.8%
Lifevest Wcd 3100 System	1,500	0	2.3%
LifeVest WCD 5100 System	1,189	1,076	1%
Lifevest Wcd 4000 Sys	371	0	3%
Assure Cardiac Recovery System	208	0	4.8%

Ordered by report count for navigation only. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data." FDA also states that "common products may have a higher number of adverse events due to the higher total number of people using the product."

Questions about Assure Wearable Cardioverter Defibrillator reports

How many FDA reports name Assure Wearable Cardioverter Defibrillator?

1,118 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 730 in the latest 12 months.

What kinds of events are reported?

malfunction (96.2%), death (3.5%) and injury (0.4%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.

What device problems are coded?

electrical /electronic property problem (46.2%), inappropriate/inadequate shock/stimulation (39.7%), failure to power up (10.1%), failure to charge (0.6%) and connection problem (0.2%). These are FDA's device problem codes as entered on the report.

Who files these reports?

manufacturer reports (99.9%) and voluntary reports (0.1%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.

Do these reports show that Assure Wearable Cardioverter Defibrillator was at fault?

No. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data." FDA adds that "a causal relationship cannot be established between product and reactions listed in a report."

How do I report a problem with a medical device?

Through FDA MedWatch (Form FDA 3500 for health professionals and consumers), or to the manufacturer. See the guide on how to report.

Where this comes from. Counts are built from the openFDA Device Adverse Event (MAUDE) bulk export released 28 Sep 2026, which holds reports FDA received through 31 Aug 2026. Brand, generic and manufacturer names are as written on the reports; product code names come from FDA's device classification. A report counts here when any device it lists carries this brand name after punctuation and capitalisation are normalised. No report narrative, lot number, patient detail or reporter identity is published. See the methodology and sources; FDA's record is authoritative, and corrections are handled within five working days.

Drug data (FAERS) through 30 Jun 2026; device data (MAUDE) through 31 Aug 2026. Not medical advice.