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Integra® INSHITHRecalls & reported problems

Integra Pain Management · Integra® Cranial Access Kit

1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.

Adverse event reports
1
Deaths reported
0
Injuries reported
0
Recalls naming it
1

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10381780263968), received between Dec 7, 2022 and Dec 7, 2022 — classified as 1 malfunction.

The most frequently reported specific device problem is “Difficult to Remove” (1 report).

1 FDA recall record name this device's identifier, 1 still open.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

  1. Jan 19, 2024Open, Classified

    A defect in the sterile packaging (header bag) of the Cranial Access Kit failing the required packaging integrity testing criteria. Therefore, product sterility maybe compromised.

    Z-1201-2024 · Root cause: Process control · FDA record ↗

Most reported problems

Device problems

  • Difficult to Remove1
  • Material Integrity Problem1

Patient problems

  • Unspecified Tissue Injury1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • MalfunctionDec 7, 2022Difficult to Remove; Material Integrity Problem

    PRODUCT RECALL FOR HCA HOUSTON HEALTHCARE CRANIAL ACCESS KITS CONTAINING STERI-DRAPE SURGICAL DRAPES- AN INVESTIGATION IDENTIFIED THAT THE LINER ON THE ADHESIVE COMPONENT OF THE DRAPES IS DIFFICULT TO REMOVE WITHOUT DAMAGING THE PRODUCT AND RENDERING THE PRODUCT UNUSABLE. THERE WAS AN OBSERVED INCREASE IN REPORTED ADHESIVE-RELATED SKIN INJURIES FOR THESE AFFECTED LOTS.

    Patient problems: Unspecified Tissue Injury

    MAUDE report 15940726 ↗

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.