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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 83882

1 recalled-product record grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
September 25, 2019
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
ENDOTRONIX

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 1

myCordella Patient Kit without ECG, The Cordella System is a comprehensive at-home heart failure management platform that provides the clinician tools to monitor the progression of heart failure.

Z-0542-2020
Recall number
Z-0542-2020
Initiated
September 25, 2019
Classification
Class II
Status
Terminated
Recalling firm
ENDOTRONIX
Quantity
58 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The firm have received reports of patients myCordella Hubs fully powering themselves down without interaction from the patient or Endotronix.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Other

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The firm have received reports of patients myCordella Hubs fully powering themselves down without interaction from the patient or Endotronix.

Code information

Model Number 100171-00 Serial Numbers: 352616080403550 352616080468181 352616080592774 352616080559617 352616080399550 352616080560235 352616080460865 352616080561431 352616080561209 352616080472167 352616080559377 352616080560227 352616080468553 352616080560532 352616080559468 352616080561472 352616080460907 352616080559872 352616080560904 352616080558585 352616080560524 352616080559716 352616080560318 352616080691550 352616080690792 352616080687749 352616080684563 352616080687921 352616080675512 352616080677948 352616080691618 352616080674382 352616080683151 352616080678490 352616080682914 352616080679522 352616080672022 352616080679936 352616080605469 352616080596106 352616080613463 352616080680553 352616080678169 352616080670562 352616080679191 352616080682898 352616080678581 352616080673905 352616080692285 352616080690149 352616080603852 352616080692244 352616080677617 352616080687764 352616080690909 352616080677906 352616080604512 352616080608745

Distribution pattern

TX, IL, GA