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Barricade Coil System 900001Recalls & reported problems

Balt USA LLC · Barricade Coil System (BCS) is intended for the endovascular embolization of intracranial aneurysms and other neurovascular abnormalities such as arteriovenous malformations and arteriovenous fistulae. The BCS is also intended for vascular occlusion of blood vessels within the neurovascular system to permanently obstruct blood flow to an aneurysm or other vascular malformation and for arterial and venous embolizations in the peripheral vasculature. The BCS consists of an implantable coil attached to a delivery pusher. The delivery pusher is powered by the Blockade Detachment Controller (BDC) designed specifically for the BCS. The device comes pre-loaded with one 9-volt battery. A BlockWire Connecting Cable or Handheld Detachment Cable, comprised of a red and black cable leads are required to detach Barricade Detachable Coils and must be used in conjunction with a return electrode. · Class 2 · Implant

All models of Barricade Coil System (18)

Data updated Oct 16, 2026 from official FDA records · Editorial policy

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

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00818053020025), received between Jan 25, 2022 and Jan 25, 2022 — classified as 1 malfunction.

The most frequently reported specific device problem is “Migration” (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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Device problems

  • Migration1
  • Premature Separation1

Patient problems

  • No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

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

  • MalfunctionJan 25, 2022Migration; Premature Separation; Migration; Premature Separation

    IT WAS REPORTED THAT: "<PATIENT INFORMATION> SEX/AGE: UNKNOWN. LOCATION: M1 DISTAL. PROCEDURE: PLANNED TAE FOR UNRUPTURED ANEURYSM. SIZE OF ANEURYSM: 5×5×5×2MM. MICRO CATHETER: PHENOM17/MEDTRONIC (0.017INCH). <DESCRIPTION> AFTER PLACING 2 COMPETITIVE COILS AND 2 BARRICADE COILS, DURING THE THIRD BARRICADE COIL INSERTION, THE PHYSICIAN FELT RESISTANCE TO OPERATE COIL. THEN THE PHYSICIAN CONTINUED ATTEMPT WITH DOUBLE CATHETER TECHNIQUE(ANOTHER CATHETER WAS SL-10) (THE PHYSICIAN REPEAT ADVANCING AND RETRIEVING COIL FOR THREE TIMES) . THEN THE PHYSICIAN NOTICED THAT THE COIL DID NOT FOLLOW PUSHER WIRE NO LONGER SINCE THE COIL HAS BEEN DETACHED. THEN THEY TRIED TO RETRIEVE THE COIL WITH SNARE, BUT IT FAILED. THE COIL WAS PUSHED INTO DISTAL SIDE OF PARENT ARTERY. ALTHOUGH THE PHYSICIAN CONSIDERED TO PLACE STENT, THEY FINALLY FINISHED PROCEDURE JUST CONFIRMING BLOOD FLOW SINCE THERE WAS THE RISK OF PUSHING THE COIL INTO FURTHER DISTAL OF ARTERY." 05JAN2022 UPDATE - ADDITIONAL INFORMATION RECEIVED FROM ISSUER: "PREMATURE DETACHMENT OF THE IMPLANT OCCURRED IN THE MICROCATHETER, THEN THE IMPLANT FELL INTO THE PARENT ARTERY AFTER THE PHYSICIAN ATTEMPTED TO RETRIEVE THE IMPLANT WITH A SNARE. T

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 13342917 ↗

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Sources and updates

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