Reported Reactions

Devices › Filter, intravascular, cardiovascular

Device brand name · Vena cava filter

Recovery Filter: medical device reports filed with FDA

357 reports name it, 2003–2021. Manufacturer given most often on reports: Bard Peripheral Vascular. Product code DTK.

357
device reports naming the brand
0% of all MAUDE reports · about 16 a year
0
reports, 12 months to August 2026
0 in the 12 months before
71.7%
classified as malfunction
29.9% across the product code
4.8%
classified as death, as reported
17 reports · not verified by FDA

FDA's MAUDE database holds 357 reports that name the brand "Recovery Filter" (vena cava filter), received between November 2003 and April 2021; the manufacturer given most often on reports is Bard Peripheral Vascular. Spellings of one product vary from report to report.

0 reports arrived in the 12 months to August 2026, and none 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 (71.7%), injury (23%) and death (4.8%); across all filter, intravascular, cardiovascular reports (product code DTK) death is recorded in 2.4% and malfunction in 29.9%. Event type is the reporter's classification of the report, not a verified outcome.

The device problems coded most often are explanted (28.6%), migration or expulsion of device (23.2%) and device remains implanted (18.2%). The patient problems coded most often are surgical procedure, nonresorbable materials, unretrieved in body and therapy/non-surgical treatment, additional. 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

No report naming Recovery Filter was received in the five years to August 2026; the latest was received in April 2021.

By year received

0521042003: 320032004: 9920042005: 10420052006: 4920062007: 320072019: 3320192020: 5920202021: 72021

Event type and report source

Event type, as classified on the report

Death4.8%17
Injury23%82
Malfunction71.7%256
Other0%0
Not given0.6%2

Who filed the report

Manufacturer report98.9%353
Voluntary report1.1%4
User facility report0%0
Distributor report0%0
Not given0%0

Grey bar: all 38,361 reports carrying product code DTK. Event type is the filer's classification and is not verified by FDA.

Device problems coded

Device problem (FDA code)ReportsShareShare across product code
Explanted10228.6%0.8%
Migration or expulsion of device8323.2%9.6%
Device remains implanted6518.2%2%
Difficult to removethe device was hard to remove5314.8%19.8%
Detachment of device component5214.6%1.9%
Device, or device fragments remain in patient4713.2%0.5%
Patient device interaction problem4612.9%6.4%
Malposition of device4312%10.9%
Detachment of device or device componentpart of the device came off4011.2%7.8%
Patient-device incompatibilitythe device did not suit the patient267.3%4.3%
Replace246.7%1.4%
Component missing174.8%0.1%
Fracturea broken bone143.9%7.3%
Device, removal of (non-implant)102.8%0.3%
Difficult to position82.2%0.2%
Material deformation82.2%1.2%
Implant, removal of72%0.2%
Component(s), broken61.7%0.1%
Difficult or delayed positioning61.7%1.3%
Material perforation61.7%1%

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)ReportsShare
Surgical procedure9927.7%
Nonresorbable materials, unretrieved in body4813.4%
Therapy/non-surgical treatment, additional277.6%
Chest painchest pain215.9%
Pulmonary embolisma blood clot in the lung195.3%
Deaththe patient died; cause not stated by this term164.5%
Hospitalization required154.2%
Foreign body, removal of143.9%
Painpain, site not specified143.9%
Clotting133.6%
Great vessel perforation102.8%
Breathing difficulties82.2%
Surgical procedure, repeated82.2%
Thrombosis72%
Abdominal painstomach or belly pain61.7%

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

In context

MeasureRecovery FilterProduct code DTKAll MAUDE reports
Reports35738,36126,136,888
Share of that pool—0.9%0%
Classified as death, per 1,000 reports48249
Classified as injury23%67%36.2%
Classified as malfunction71.7%29.9%62.3%
Filed by the manufacturer98.9%93%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 DTK

BrandReportsLatest 12 monthsClassified as death
Gunther Tulip Femoral Vena Cava Filter Set1,92600.6%
Gunther Tulip Jugular Vena Cava Filter Set1,23500.7%
G2 Filter System - Femoral1,12203.7%
Denali Femoral System928784.6%
466fxxxx93601.9%
Cook Celect Femoral Vena Cava Filter Set89801.3%
Unknown Optease Vena Cava Filter83501.7%
Greenfield73550.5%
Unknown Trapease72001.7%
Denali Jugular System704456.3%
Option Ivc Filter70202.1%
Trapease Pvcf Fem/Jug 55cm Csi98303.7%
Optease Retrieval Filter68503.4%
Cook Celect Navalign Femoral Vena Cava Filter Set67301.5%
Eclipse Filter System - Femoral64906%

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 Recovery Filter reports

How many FDA reports name Recovery Filter?

357 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 0 in the latest 12 months.

What kinds of events are reported?

malfunction (71.7%), injury (23%) and death (4.8%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.

What device problems are coded?

explanted (28.6%), migration or expulsion of device (23.2%), device remains implanted (18.2%), difficult to remove (14.8%) and detachment of device component (14.6%). These are FDA's device problem codes as entered on the report.

Who files these reports?

manufacturer reports (98.9%) and voluntary reports (1.1%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.

Do these reports show that Recovery Filter 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.