Prestige Coil System PRESPACK65V02Recalls & 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
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00840303712114), received between Feb 6, 2026 and Apr 24, 2026 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Premature Separation” (3 reports).
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 Separation3
- Failure to Advance2
- Difficult to Advance1
- Stretched1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 24, 2026Failure to Advance; Premature Separation
IT WAS REPORTED THAT: "TWO COMPLEX PRESTIGE COILS WENT INTO A 4.5MM VENOUS COLLATERAL VESSEL AT (B)(6). THE PHYSICIAN WANTED TO PUT IN TWO PACKING COILS BEHIND THROUGH A PROGREAT 2.0 MICRO. THEY FELT RESISTANCE WHEN ADVANCING THROUGH THE MICRO CATHETER AND THE COIL PREDETACHED. THEY COIL COULD HAVE EITHER KNOTTED OR GOTTEN PINCHED IN THE GLIDECATH BASE CATHETER. SAME THING HAPPENED WITH ANOTHER PACKING COIL. SNARED COIL JUST FINE, NO HARM TO THE PATIENT." INCIDENT REPORT FORM SUBMITTED FOR THIS COMPLAINT INDICATES THAT NO PATIENT INJURY WAS SUSTAINED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24983848 ↗MalfunctionApr 24, 2026Failure to Advance; Premature Separation
IT WAS REPORTED THAT: "TWO COMPLEX PRESTIGE COILS WENT INTO A 4.5MM VENOUS COLLATERAL VESSEL AT DUKE. THE PHYSICIAN WANTED TO PUT IN TWO PACKING COILS BEHIND THROUGH A PROGREAT 2.0 MICRO. THEY FELT RESISTANCE WHEN ADVANCING THROUGH THE MICRO CATHETER AND THE COIL PREDETACHED. THEY COIL COULD HAVE EITHER KNOTTED OR GOTTEN PINCHED IN THE GLIDECATH BASE CATHETER. SAME THING HAPPENED WITH ANOTHER PACKING COIL. SNARED COIL JUST FINE, NO HARM TO THE PATIENT." INCIDENT REPORT FORM SUBMITTED FOR THIS COMPLAINT INDICATES THAT NO PATIENT INJURY WAS SUSTAINED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24983824 ↗MalfunctionFeb 6, 2026Stretched; Difficult to Advance; Premature Separation
IT WAS REPORTED THAT: "THIS COIL UNRAVELED. WHEN TRYING TO RETRACT AND REPOSITION THE DOCTOR FELT THE COIL DETACH, HE TRIED TO CONTINUE TO PUSH IT INTO THE ANEURYSM AND WHEN HE MET RESISTANCE HE TRIED TO REMOVE THE COIL AND IT BEGAN UNRAVELING. THEY TRIED TO SNARE AND WHEN IT FAILED THE COIL BROKE IN THE CATHETER. THEY FLUSHED THE REST OF THE COIL INTO THE VESSEL AND KEPT THE MICRO AND WHAT WE WERE ABLE TO REMOVE OF THE COIL. THE CASE ENDED UP FINE." INCIDENT REPORT FORM SUBMITTED FOR THIS COMPLAINT INDICATES THAT NO PATIENT INJURY WAS SUSTAINED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24284257 ↗
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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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