Prestige Coil System PRES1665CPKPLTRecalls & reported problems
Balt USA LLC · The Prestige Coil System is indicated for arterial and venous embolizations in the peripheral vasculature. It is designed for use with 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 00810068567779), received between Jun 6, 2025 and Jun 6, 2025 — classified as 1 malfunction.
The most frequently reported specific device problem is “Premature Separation” (1 report).
2 other recalls cover devices cleared under the same FDA submission (K220699); they may or may not involve this specific model.
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
Most reported problems
Device problems
- 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.
MalfunctionJun 6, 2025Premature Separation; Premature Separation
IT WAS REPORTED THAT: "HYPO COIL CASE WITH A 2.8 PROGRET MICRO. COIL WAS ADVANCED AND THEN UPON REPOSITIONING FOR THE 1ST TIME, THE COIL SEPARATED WITH MINIMAL TENSION ON RETRACTION. WE WERE ABLE TO ADVANCE THE COIL IN USING BACK END OF THE COIL PUSHER AND MANAGED TO GET 45CM OUTR. WE THEN USED THE BACK END OF AN .018 WIRE TO LUCKILY ADVANCE IT THE REST OF THE WAY IN. IT HAPPENED TO LAND IN A GOOD SPOT TO CONTINUE TO CASE.THIS WAS THE 1ST COIL IN ON THIS CASE." UPDATE 08MAY2025 - ADDITIONAL INFORMATION RECEIVED FROM THE ISSUER: "MINIMAL TORTUOSITY." INCIDENT REPORT FORM SUBMITTED FOR THIS COMPLAINT INDICATES THAT NO PATIENT INJURY WAS SUSTAINED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22159795 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K220699. One submission often covers many models, so check the product and lot details in each record.
- Z-1989-2025 · May 8, 2025 · Open, ClassifiedPrestige Coil System REFs/UDI-DI codes: PRES0153CXPPLT 00810068567311 PRES1045CPKPLT 00810068567663 PRES1245CPKPLT 00810068567694 PRES1445CPKPLT 00810068567724 PRES0103CXPPLT 00810
- Z-1042-2024 · Jan 3, 2024 · Open, ClassifiedThe Prestige Coil System is a product family of embolic coils with associated delivery system components. These devices are angiographically delivered through the vasculature to em
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- Azur CX Detachable 45-750824Microvention, Inc. · Device, Vascular, for Promoting Embolization115 reports
- Tornado G08261Cook Incorporated · Device, Vascular, for Promoting Embolization2 recalls7 reports
- Optima Coil System OPTI0930CSFMXBalt USA LLC · Device, Vascular, For Promoting Embolization2 recalls4 reports
- Optima Coil System OPTI0720CSFMXBalt USA LLC · Device, Vascular, For Promoting Embolization2 recalls4 reports
- Prestige Coil System PRES0520HPKPLBalt USA LLC · Device, Vascular, For Promoting Embolization2 recalls3 reports
- Optima Coil System OPTI0413CSFMXBalt USA LLC · Device, Vascular, For Promoting Embolization2 recalls3 reports
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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