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Adverse-event reports (MAUDE)

Read this first: MAUDE report counts cannot be used to compute incidence rates or compare device safety. Reporting is incomplete, duplicated, and spikes with publicity; there is no denominator of devices in use. The peer line shows reporting volume for the average device in the same FDA product code — a reporting baseline, not a risk measure.

No adverse-event reports are linked to this device.

Recall history
InitiatedRecall #ClassStatusReasonQuantityLink basis
2019-06-14Z-1977-2019Class IITerminatedThe soft, flexible cup of the Advincula Delineator may be unvalidated and could potentiall crack when subjected to excessive compressions during use, leading to serious health consequences, such as lacerations.Distribution: US distribution to state of: AZ, CA, GA, IN, LA, MA, NC, NH, NJ, NY, OH, PA, VA, and WA..213 units in totalclearance family
2019-06-14Z-1978-2019Class IITerminatedThe soft, flexible cup of the Advincula Delineator may be unvalidated and could potentiall crack when subjected to excessive compressions during use, leading to serious health consequences, such as lacerations.Distribution: US distribution to state of: AZ, CA, GA, IN, LA, MA, NC, NH, NJ, NY, OH, PA, VA, and WA..213 units in totalclearance family
Regulatory clearances
  • 510(k)K180429Substantially equivalent (SESE) · 2018-03-14clearance family

Predicate lineage

Cited as predicate by: K201086

Lineage each submission cites, walked transitively (indented = the cited device's own predicates). Extracted from public 510(k) summary text — heuristic, and includes reference devices mentioned alongside true predicates.

Manufacturer compliance record
DateTypeOutcomeFacilityCitations
2024-02-01VAIVoluntary action indicatedCooperSurgical, Inc.0
2023-05-16NAINo action indicatedCooperSurgical, Inc.0
2023-05-16NAINo action indicatedCooperSurgical, Inc.0
2023-04-27VAIVoluntary action indicatedLone Star Medical Products, Inc.5
2022-12-15NAINo action indicatedLeisegang Feinmechanick-Optik GmbH0
2021-07-15VAIVoluntary action indicatedCooperSurgical, Inc.4
2021-07-15VAIVoluntary action indicatedCooperSurgical, Inc.4
2019-08-01NAINo action indicatedCooperSurgical, Inc.2
2018-05-02NAINo action indicatedLone Star Medical Products, Inc.0
2017-12-07NAINo action indicatedCooperSurgical, Inc.0
2017-12-07NAINo action indicatedCooperSurgical, Inc.0
2017-05-04NAINo action indicatedLone Star Medical Products, Inc.0
2016-03-31NAINo action indicatedCooperSurgical, Inc.0
2016-03-31NAINo action indicatedCooperSurgical, Inc.0
2015-12-10NAINo action indicatedLeisegang Feinmechanick-Optik GmbH0
2015-06-09WLWarning LetterCooperSurgical, Inc.—
2015-06-09WLWarning LetterCooperSurgical, Inc.—
2014-12-17OAIOfficial action indicatedCooperSurgical, Inc.8
2014-12-17OAIOfficial action indicatedCooperSurgical, Inc.8
2014-12-01NAINo action indicatedCooperSurgical, Inc.0
2014-12-01NAINo action indicatedCooperSurgical, Inc.0
2014-09-23VAIVoluntary action indicatedLone Star Medical Products, Inc.0
2013-04-25WLWarning LetterLone Star Medical Products, Inc.—
2012-07-11WLWarning LetterLeisegang Feinmechanick-Optik GmbH—
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