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Integra®

INTEGRA NEUROSCIENCES IMPLANT (FRANCE) · Model 40M40 · UDI-DI 10381780034872

IKD Prescription

510(k) clearances

475

Adverse events (6 deaths)

Recalls

218

Facilities

Description

The female electrode connecting cable is a reusable device used to connect the Integra® Cortical and Depth electrodes to an EEG monitor through 2 Cam Lock cylindrical Connector. It has 24 gold plated connector pins corresponding to the electrode Contacts, to be plugged into the corresponding EEG Monitor input channels. It features an intermediate connector at 30cm allowing an easy disconnection if desired.

Recalls

Date	Firm	Reason
2024-07-02	Stryker Sustainability Solutions	Disposable 5 lead cable and lead wire system package that should contain lead systems, lead telemetry systems and a dual connect cable, may in fact contain, different ECG Leads, wh
2021-08-09	Ad-Tech Medical Instrument Corporation	Incorrect version of labels were used.
2021-08-09	Ad-Tech Medical Instrument Corporation	Incorrect version of labels were used.
2021-08-09	Ad-Tech Medical Instrument Corporation	Incorrect version of labels were used.
2019-02-22	GE Healthcare, LLC	The Integrated ECG cable with 3-lead leadwires can short circuit during defibrillation and conduct 25% of the defibrillation energy away from the patient.
2017-03-31	Oscor, Inc.	The Reusable Oscor ATAR extension cables could separate from the connector during use.
2017-03-31	Oscor, Inc.	The Reusable Oscor ATAR extension cables could separate from the connector during use.
2016-03-29	Ad-Tech Medical Instrument Corporation	Ad-Tech is recalling unopened/unused sterile cables intended to be used only with all compatible Ad-Tech electrodes for the purpose of connecting these electrodes to third party mo
2011-06-01	St. Jude Medical	St. Jude Medical is recalling a single lot (3334664) of Supreme Electrophysiology Extension Cable which were packaged with a Quadripolar cable instead of a hexapolar Cable. St. J
2011-02-08	Vermed, Inc.	Vermed kits contain a product component (Triad Alcohol Prep Pads) recalled due to potential Bacillus cereus contamination.

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.