Barricaid® ACD Impactor 400906-ARecalls & reported problems

Intrinsic Therapeutics, Inc. · Single-use disposable surgical instrument to aid in insertion of the Barricaid® Annular Closure Device (ACD), in the event that additional impaction is necessary. · Class 1

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

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI M906BARIMPACTOR0), received between Jul 11, 2025 and Jul 11, 2025 — classified as 1 injury.

The most frequently reported specific device problem is “Improper or Incorrect Procedure or Method” (1 report).

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.

Reports received per month

Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

Improper or Incorrect Procedure or Method1

Patient problems

Hernia1

Recent adverse event reports

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

InjuryJul 11, 2025Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method
WHILE INVESTIGATING A REPORT OF AN IMPACTOR DAMAGING AN IMPLANT DURING USE, IT WAS DETERMINED THAT THE PATIENT HAD LATER REHERNATED AND A REOPERATION WAS PERFORMED. THE DAMAGED PORTION OF THE IMPLANT WAS REMOVED DURING THIS REVISION SURGERY.
Patient problems: Hernia
MAUDE report 22484783 ↗

Device details

UDI-DI	`M906BARIMPACTOR0`
Brand	Barricaid® ACD Impactor
Model	400906-A
Catalog no.	BAR-IMPACTOR
Company	Intrinsic Therapeutics, Inc.
Product code	LXH · Orthopedic Manual Surgical Instrument
Class	Class 1
FDA submission	None listed
Implant	No
Rx / OTC	—
Single use	Yes
Sterile	Yes
MRI safety	Labeling does not contain MRI Safety Information
Status	In Commercial Distribution
Record updated	Sep 11, 2024

Device type (GMDN): Orthopaedic inorganic implant inserter/extractor, single-use

A hand-held manual surgical instrument designed for the surgical insertion and/or extraction of a non-tissue based (inorganic) orthopaedic implant (e.g., a bone nail, spiral blade, or bone fixation plate). It is an instrument in a one-piece or modular configuration with a region that will attach/fit/lock to part of the implant, and typically features either a mechanism to apply a striking force (e.g., on a pad/flange) a mechanism for twisting (screwing) (e.g., T-handle), or a plunger mechanism to deploy a guide to drive the implant into place. This is a single-use device.

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