Prestige Coil System PRESPACK30V02Recalls & reported problems

Balt USA LLC · The Prestige Packing Coil consists of an implantable embolization coil comprised of a platinum-tungsten alloy attached to a proximal stainless steel hypo-tube and distal body coil delivery pusher with a radiopaque distal positioning marker and a proximal fluorosafe marker. The Prestige Packing Coil delivery pusher is 185cm in length. It is designed for use with the Ultra Detachment Controller. The Ultra Detachment Controller comes pre-loaded with batteries and is a sterile, handheld, single-patient-use device which should not to be reused, re-sterilized, opened or tampered with. The Prestige Packing Coil and Ultra Detachment Controller(s) are sold separately. The Prestige Packing Coil achieves detachment by an internal heater element, which is powered by the Ultra Detachment Controller. · Class 2 · Implant

All models of Prestige Coil System (97)

Data updated Oct 18, 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 00840303712046), received between Aug 4, 2025 and Aug 4, 2025 — classified as 1 malfunction.

The most frequently reported specific device problem is “Separation Problem” (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 18, 2026.

Reports received per month

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

Most reported problems

Device problems

Separation Problem1
Stretched1

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.

MalfunctionAug 4, 2025Stretched; Separation Problem; Stretched; Separation Problem
IT WAS REPORTED THAT: "PRESPACK30 WAS UTILIZED IN A PELVIC EMBO COIL TRACKED AND PACKED GREAT GOT GREEN LIGHT ON ULTRA AND COIL DID NOT FULLY DETACH. BELIEVE THE PUSHER BECAME ENTANGLED WITH COIL AND PULLED COIL BACK. WE THEN TRIED TO SNARE THROUGH 4 FRENCH CATHETER, WAS ABLE TO GET ABOUT 15CM PULLED BACK AND THEN COIL STRETCHED. STARTED TO PULL STRETCH COIL AND REST OF COIL CAME OUT OF BODY. NO INJURY TO PATIENT UTILIZED (2) 2X12 AND 2X8 AND 2X4 WITH OUT ISSUE. " UPDATE 08JUL2025 - ADDITIONAL INFORMATION RECEIVED FROM THE ISSUER: "1. HOW WOULD THE TORTUOSITY BE DESCRIBED IN THIS PROCEDURE? SOME TORTUOUS VESSEL 2. CAN YOU CONFIRM IF THE SUPPLEMENTAL ACCESSORIES WILL BE RETURNED? (XCEL, MICROCATHETER, ETC) IF SO, IT WOULD BE APPRECIATED. YES 3. CAN YOU CONFIRM IF THE IMPLANT DETACHED AT ANY POINT IN THE PROCEDURE? YES BUT SEEMED TO BE ENTANGLED". UPDATE 16JUL2025 - ADDITIONAL INFORMATION RECEIVED FROM THE ISSUER: 1. WAS THE DETACHMENT OF THE IMPLANT COIL ACHIEVED FROM THE PHYSICIAN PRESSING THE DETACHMENT BUTTON ON THE CONTROLLER? I BELIEVE SO, THINK THE PUSHER WAS ENTANGLED IN COIL WHICH CAUSED COIL TO BE PULLED BACK INCIDENT REPORT FORM SUBMITTED FOR THIS COMPLAINT INDICATES THAT
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22701778 ↗

Device details

UDI-DI	`00840303712046`
Brand	Prestige Coil System
Model	PRESPACK30V02
Catalog no.	N/A
Company	Balt USA LLC
Product code	KRD · Device, Vascular, For Promoting Embolization
Class	Class 2
FDA submission	K251383
Implant	Yes
Rx / OTC	Prescription
Single use	Yes
Sterile	Yes
MRI safety	MR Conditional
Status	In Commercial Distribution
Record updated	Jun 16, 2025

Device type (GMDN): Non-neurovascular embolization coil

A non-bioabsorbable, implantable device intended to induce a thrombosis within a non-neurovascular blood vessel to treat an aneurysm and/or non-neurovascular arteriovenous malformation (AVM); it is not intended for neurovascular application. It is in the form of a metal or metal/synthetic polymer wire which coils upon deployment within an aneurysm or the vasculature surrounding a malformation; it is typically pre-attached to a nonimplantable delivery wire. Disposable devices associated with implantation (e.g., delivery wire, catheter) may be included.

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Sources and updates

Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.

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