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ACCLARENT, INC.

308 adverse events · 34 clearances · 28 recalls · 8 inspections · 4 compliance actions · aggregated across 3 source records

Scorecard
Events per device across the 127-device portfolio, trailing 12 months. Arrows compare the last 90 days with the 90 before.

MAUDE reports per device

0.13 →

17 in the last 12 months

Higher volume than 94% of companies with 10+ devices

Recalls per device

0 →

0 in the last 12 months

Higher volume than 97% of companies with 10+ devices

These are reporting-volume percentiles, not safety rankings — MAUDE counts have no denominator of devices in use, and recall attribution follows resolved links. A high percentile means more reports per registered device than peers, which can reflect market size, device criticality, or reporting practice as much as anything else.

Devices
127 device records · ordered by linked event volume.
BrandModelProduct codesPrimary DILinked events
TruDi NAV SuctionTDNS000ZPGW10705031245877160
RELIEVA SPINPLUS NAVRSP0616MFSNLRC PGW1070503124101570
TruDi NAV SuctionTDNS070ZPGW1070503124588470
ACCLARENT BALLOON INFLATION DEVICEBID30LRC1070503106357063
TruDi NAV SuctionTDNS090ZPGW1070503124589136
TruDi Shaver BladeTSB4STRERL PGW1070503146923536
TruDi ProbeTDP0005PGW1070503146419328
ACCLARENT PIVOTPVT0616NLRC PGW PNZ1070503146559624
TruDi CuretteTDC0005PGW1070503146542823
RELIEVA TRACTRT1640AQGK1070503146264918
RELIEVA SPINPLUSRSP0616MFSLRC1070503123238916
ACCLARENT AERAEU061655PNZ1070503123088014
TruDi Shaver BladeTSB415ERL PGW1070503146929714
TruDi NAV CableTDNC001PGW1070503124585313
TruDi ProbeTDP0705PGW1070503146420911
INSPIRA AIRBC1640AKTI1070503114774410
RELIEVA SPINPLUS NAVRSP0616MFSNZLRC PGW207050312454306
TruDi NAV CableTDNC001ZPGW207050312458676
ACCLARENT AERAEU061655ZPNZ207050312308705
RELIEVA TRACTRT1640AZQGK207050314626535
INSPIRA AIRBC1440AKTI107050310633104
TruDi ProbeTDP0705ZPGW207050314642204
INSPIRA AIRBC0524AZKTI207050310630893
RELIEVA ULTIRRABC0616RULRC107050312002723
RELIEVA ULTIRRABC0716RULRC107050312002893
TruDi Shaver BladeTSB460ERL PGW107050314692113
RELIEVA SPINPLUSRSP0516MFSZLRC207050312328292
RELIEVA ULTIRRABC0516RULRC107050312002582
RELIEVA ULTIRRABC0724RULRC107050312002962
TruDi Shaver BladeTSB415ZERL PGW207050314692872
Showing 1–30 of 127Next →
Compliance actions
FDA warning letters and enforcement actions (full history).
DateTypeActionFirm
2013-03-20WLWarning LetterAcclarent, Inc.
2013-03-20WLWarning LetterAcclarent, Inc.
2012-06-14WLWarning LetterAcclarent, Inc.
2012-06-14WLWarning LetterAcclarent, Inc.
Facilities
Registered establishments with their latest FDA inspection outcome.
FEINameLocationLast inspectionWatch
3005172759ACCLARENT, INC.Irvine, CA, USNAI