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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 90457

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

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Event summary

Timeline bucket
June 22, 2022
Product types
Device
Classifications
Class I
Statuses
Ongoing
Recalling firm wording
Integra LifeSciences Corp.

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

CereLink ICP Monitor; Catalog No. 826820, 826820P. Intracranial pressure monitor.

Z-1395-2022
Recall number
Z-1395-2022
Initiated
June 22, 2022
Classification
Class I
Status
Ongoing
Quantity
1,210 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Integra has received complaints associated with ICP readings drifting to -50 mmHg (out-of-range) and may manifest an error message "sensor or extension cable failure!" The firm has found that this is caused by electrical interference from a component of the monitor's circuit board and from the environment.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Integra has received complaints associated with ICP readings drifting to -50 mmHg (out-of-range) and may manifest an error message "sensor or extension cable failure!" The firm has found that this is caused by electrical interference from a component of the monitor's circuit board and from the environment.

Code information

UDI-DI- 10381780533778; All serial numbers.

Distribution pattern

Worldwide Distribution: US nationwide, Australia, New Zealand, Canada, Hong Kong, Pakistan, Georgia, Saudi Arabia, Israel, South Africa, United Arab Emirates, Austria, Belgium, Czech Republic, Denmark, Estonia, Finland, France, Germany, Great Britain, Greece, Ireland, Italy, Latvia, Lithuania, Netherlands, Norway, Portugal, Switzerland, Spain, Sweden, Slovakia, and United Kingdom.