Prestige Coil SystemRecalls & reported problems across all models

We found 97 models of Prestige Coil System by Balt USA LLC in the FDA's device registry (GUDID). Together they are named in 40 adverse event reports in the FDA's MAUDE database, received between Oct 12, 2021 and Aug 3, 2026 — classified as 2 injuries, 38 malfunctions.

The most frequently reported specific device problem is “Premature Separation” (27 reports).

2 FDA recall records name at least one of these models by its device identifier, 2 still open.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Prestige Coil System recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

1. May 8, 2025Open, Classified

   Due to radiopaque (RO) marker was not visible during angiography and it was determined that the RO marker was not manufactured to specification.

   Z-1989-2025 · Root cause: Vendor change control · names 38 of these models · Recall details · FDA record ↗

2. Jan 3, 2024Open, Classified

   Discoloration was identified along the delivery pusher which was attributed to corrosion of the hypotube. The material which caused the corrosion was identified as remnants of solder flux residue remaining on the hypotube component of the delivery pusher. Due to the location of the delivery pusher within the delivery system, it is possible for the discoloration to mechanically break off from the delivery pusher, leaving the potential for the material to flow through the delivery system (i.e. microcatheter), and into the patient vasculature causing foreign emboli.

   Z-1042-2024 · Root cause: Material/Component Contamination · names 58 of these models · Recall details · FDA record ↗

Most reported Prestige Coil System problems

Prestige Coil System models

97 models, most reported first. Each model has its own page with its reports, recalls and device details.

• Prestige Coil System PRES0520HPKPL

  Device, Vascular, For Promoting Embolization
  2 recalls3 reports
• Prestige Coil System PRES0153HXPPL

  Device, Vascular, For Promoting Embolization
  2 recalls0 reports
• Prestige Coil System PRES0315HXPPL

  Device, Vascular, For Promoting Embolization
  2 recalls0 reports
• Prestige Coil System PRES0420HPKPL

  Device, Vascular, For Promoting Embolization
  2 recalls0 reports
• Prestige Coil System PRES0720HPKPL

  Device, Vascular, For Promoting Embolization
  2 recalls0 reports
• Prestige Coil System PRES0830HPKPL

  Device, Vascular, For Promoting Embolization
  2 recalls0 reports
• Prestige Coil System PRES0204CXPPL

  Device, Vascular, For Promoting Embolization
  2 recalls0 reports
• Prestige Coil System PRES0307CXPPL

  Device, Vascular, For Promoting Embolization
  2 recalls0 reports
• Prestige Coil System PRES0320CXPPLT

  Device, Vascular, For Promoting Embolization
  1 recall3 reports
• Prestige Coil System PRES0204CXPPLT

  Device, Vascular, For Promoting Embolization
  1 recall2 reports
• Prestige Coil System PRES3530CXPPLT

  Device, Vascular, For Promoting Embolization
  1 recall2 reports
• Prestige Coil System PRES0635CPKPLT

  Device, Vascular, For Promoting Embolization
  1 recall2 reports
• Prestige Coil System PRES0103CXPPL

  Device, Vascular, For Promoting Embolization
  1 recall2 reports
• Prestige Coil System PRES0310CXPPLT

  Device, Vascular, For Promoting Embolization
  1 recall1 report
• Prestige Coil System PRES0420CPKPLT

  Device, Vascular, For Promoting Embolization
  1 recall1 report
• Prestige Coil System PRES0750HPKPL

  Device, Vascular, For Promoting Embolization
  1 recall1 report
• Prestige Coil System PRES0620HPKPL

  Device, Vascular, For Promoting Embolization
  1 recall1 report
• Prestige Coil System PRES0930HPKPL

  Device, Vascular, For Promoting Embolization
  1 recall1 report
• Prestige Coil System PRES0202CXPPL

  Device, Vascular, For Promoting Embolization
  1 recall1 report
• Prestige Coil System PRES0410CPKPL

  Device, Vascular, For Promoting Embolization
  1 recall1 report
• Prestige Coil System PRES0720CPKPL

  Device, Vascular, For Promoting Embolization
  1 recall1 report
• Prestige Coil System PRES1040CPKPL

  Device, Vascular, For Promoting Embolization
  1 recall1 report
• Prestige Coil System PRES1655COM18

  Device, Vascular, For Promoting Embolization
  1 recall1 report
• Prestige Coil System PRES2265COM18

  Device, Vascular, For Promoting Embolization
  1 recall1 report
• Prestige Coil System PRES0103CXPPLT

  Device, Vascular, For Promoting Embolization
  1 recall0 reports
• Prestige Coil System PRES0153CXPPLT

  Device, Vascular, For Promoting Embolization
  1 recall0 reports
• Prestige Coil System PRES0206CXPPLT

  Device, Vascular, For Promoting Embolization
  1 recall0 reports
• Prestige Coil System PRES0208CXPPLT

  Device, Vascular, For Promoting Embolization
  1 recall0 reports
• Prestige Coil System PRES0212CXPPLT

  Device, Vascular, For Promoting Embolization
  1 recall0 reports
• Prestige Coil System PRES0258CXPPLT

  Device, Vascular, For Promoting Embolization
  1 recall0 reports
• Prestige Coil System PRES2512CXPPLT

  Device, Vascular, For Promoting Embolization
  1 recall0 reports
• Prestige Coil System PRES3520CXPPLT

  Device, Vascular, For Promoting Embolization
  1 recall0 reports
• Prestige Coil System PRES0517CPKPLT

  Device, Vascular, For Promoting Embolization
  1 recall0 reports
• Prestige Coil System PRES0620CPKPLT

  Device, Vascular, For Promoting Embolization
  1 recall0 reports
• Prestige Coil System PRES0650CPKPLT

  Device, Vascular, For Promoting Embolization
  1 recall0 reports
• Prestige Coil System PRES0720CPKPLT

  Device, Vascular, For Promoting Embolization
  1 recall0 reports
• Prestige Coil System PRES0735CPKPLT

  Device, Vascular, For Promoting Embolization
  1 recall0 reports
• Prestige Coil System PRES0750CPKPLT

  Device, Vascular, For Promoting Embolization
  1 recall0 reports
• Prestige Coil System PRES0830CPKPLT

  Device, Vascular, For Promoting Embolization
  1 recall0 reports
• Prestige Coil System PRES0845CPKPLT

  Device, Vascular, For Promoting Embolization
  1 recall0 reports
• Prestige Coil System PRES1045CPKPLT

  Device, Vascular, For Promoting Embolization
  1 recall0 reports
• Prestige Coil System PRES1245CPKPLT

  Device, Vascular, For Promoting Embolization
  1 recall0 reports
• Prestige Coil System PRES1445CPKPLT

  Device, Vascular, For Promoting Embolization
  1 recall0 reports
• Prestige Coil System PRES0440HPKPL

  Device, Vascular, For Promoting Embolization
  1 recall0 reports
• Prestige Coil System PRES0540HPKPL

  Device, Vascular, For Promoting Embolization
  1 recall0 reports
• Prestige Coil System PRES0650HPKPL

  Device, Vascular, For Promoting Embolization
  1 recall0 reports
• Prestige Coil System PRES0540CPKPLT

  Device, Vascular, For Promoting Embolization
  1 recall0 reports
• Prestige Coil System PRES0101HXPPL

  Device, Vascular, For Promoting Embolization
  1 recall0 reports
• Prestige Coil System PRES0103HXPPL

  Device, Vascular, For Promoting Embolization
  1 recall0 reports
• Prestige Coil System PRES2525HXPPL

  Device, Vascular, For Promoting Embolization
  1 recall0 reports
• Prestige Coil System PRES0255HXPPL

  Device, Vascular, For Promoting Embolization
  1 recall0 reports
• Prestige Coil System PRES1040HPKPL

  Device, Vascular, For Promoting Embolization
  1 recall0 reports
• Prestige Coil System PRES0101CXPPL

  Device, Vascular, For Promoting Embolization
  1 recall0 reports
• Prestige Coil System PRES0102CXPPL

  Device, Vascular, For Promoting Embolization
  1 recall0 reports
• Prestige Coil System PRES0152CXPPL

  Device, Vascular, For Promoting Embolization
  1 recall0 reports
• Prestige Coil System PRES0153CXPPL

  Device, Vascular, For Promoting Embolization
  1 recall0 reports
• Prestige Coil System PRES0203CXPPL

  Device, Vascular, For Promoting Embolization
  1 recall0 reports
• Prestige Coil System PRES0206CXPPL

  Device, Vascular, For Promoting Embolization
  1 recall0 reports
• Prestige Coil System PRES0255CXPPL

  Device, Vascular, For Promoting Embolization
  1 recall0 reports
• Prestige Coil System PRES0303CXPPL

  Device, Vascular, For Promoting Embolization
  1 recall0 reports
• Prestige Coil System PRES0310CXPPL

  Device, Vascular, For Promoting Embolization
  1 recall0 reports
• Prestige Coil System PRES0355CXPPL

  Device, Vascular, For Promoting Embolization
  1 recall0 reports
• Prestige Coil System PRES0358CXPPL

  Device, Vascular, For Promoting Embolization
  1 recall0 reports
• Prestige Coil System PRES0404CPKPL

  Device, Vascular, For Promoting Embolization
  1 recall0 reports
• Prestige Coil System PRES0407CPKPL

  Device, Vascular, For Promoting Embolization
  1 recall0 reports
• Prestige Coil System PRES0413CPKPL

  Device, Vascular, For Promoting Embolization
  1 recall0 reports
• Prestige Coil System PRES4510CPKPL

  Device, Vascular, For Promoting Embolization
  1 recall0 reports
• Prestige Coil System PRES0510CPKPL

  Device, Vascular, For Promoting Embolization
  1 recall0 reports
• Prestige Coil System PRES0517CPKPL

  Device, Vascular, For Promoting Embolization
  1 recall0 reports
• Prestige Coil System PRES0615CPKPL

  Device, Vascular, For Promoting Embolization
  1 recall0 reports
• Prestige Coil System PRES0620CPKPL

  Device, Vascular, For Promoting Embolization
  1 recall0 reports
• Prestige Coil System PRES0820CPKPL

  Device, Vascular, For Promoting Embolization
  1 recall0 reports
• Prestige Coil System PRES0830CPKPL

  Device, Vascular, For Promoting Embolization
  1 recall0 reports
• Prestige Coil System PRES0930CPKPL

  Device, Vascular, For Promoting Embolization
  1 recall0 reports
• Prestige Coil System PRES0210CXP10

  Device, Vascular, For Promoting Embolization
  1 recall0 reports
• Prestige Coil System PRES0258CXP10

  Device, Vascular, For Promoting Embolization
  1 recall0 reports
• Prestige Coil System PRES0412CXP10

  Device, Vascular, For Promoting Embolization
  1 recall0 reports
• Prestige Coil System PRES0417CPK10

  Device, Vascular, For Promoting Embolization
  1 recall0 reports
• Prestige Coil System PRES0520CPK10

  Device, Vascular, For Promoting Embolization
  1 recall0 reports
• Prestige Coil System PRES0615CPK10

  Device, Vascular, For Promoting Embolization
  1 recall0 reports
• Prestige Coil System PRES0413CRG10

  Device, Vascular, For Promoting Embolization
  1 recall0 reports
• Prestige Coil System PRES0827COM18

  Device, Vascular, For Promoting Embolization
  1 recall0 reports
• Prestige Coil System PRES1034COM18

  Device, Vascular, For Promoting Embolization
  1 recall0 reports
• Prestige Coil System PRES1240COM18

  Device, Vascular, For Promoting Embolization
  1 recall0 reports
• Prestige Coil System PRES1447COM18

  Device, Vascular, For Promoting Embolization
  1 recall0 reports
• Prestige Coil System PRES1860COM18

  Device, Vascular, For Promoting Embolization
  1 recall0 reports
• Prestige Coil System PRES2065COM18

  Device, Vascular, For Promoting Embolization
  1 recall0 reports
• Prestige Coil System PRES2465COM18

  Device, Vascular, For Promoting Embolization
  1 recall0 reports
• Prestige Coil System PRESPACK65V02

  Device, Vascular, For Promoting Embolization
  3 reports
• Prestige Coil System PRES0410CPKPLT

  Device, Vascular, For Promoting Embolization
  2 reports
• Prestige Coil System PRES0865CPKPLT

  Device, Vascular, For Promoting Embolization
  2 reports
• Prestige Coil System PRES1465CPKPLT

  Device, Vascular, For Promoting Embolization
  2 reports
• Prestige Coil System PRES1865CPKPLT

  Device, Vascular, For Promoting Embolization
  2 reports
• Prestige Coil System PRES0156CXPPLT

  Device, Vascular, For Promoting Embolization
  1 report
• Prestige Coil System PRES1665CPKPLT

  Device, Vascular, For Promoting Embolization
  1 report
• Prestige Coil System PRES0865HPKPL

  Device, Vascular, For Promoting Embolization
  1 report
• Prestige Coil System PRESPACK30V02

  Device, Vascular, For Promoting Embolization
  1 report

Recent Prestige Coil System adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• InjuryAug 3, 2026Premature Separation

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50116669 ↗
• InjuryJul 31, 2026Premature Separation

  It was reported that:"During the procedure to place an endoprosthesis for a right common iliac artery aneurysm, the aneurysm was visualized via arteriography. Selective cannulation of the right iliac artery was performed using a guidewire; the catheter was not advanced further. VERT, Internal Mammary, and Simmons 1 catheters were used. Puncture of the left common femoral artery was performed, followed by placement of a Simmons catheter and cannulation of the contralateral right common iliac artery, without advancing the catheter into the right internal iliac artery. The 5Fr sheath in the right common femoral artery was exchanged for a long Sentran sheath. Two guidewires were passed through the Sentran sheath: a Lunderquist wire into the aorta and a hydrophilic wire into the aneurysm. A 5Fr catheter was placed over the hydrophilic wire, and a micro-guidewire and microcatheter were introduced through the 5Fr catheter. A Medtronic endoprosthesis was deployed, and the aneurysm was excluded. A coil was passed through the microcatheter; however, it was damaged and broke inside the catheter. The microcatheter was withdrawn, and an attempt was made to advance the coil using a saline flush,

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50105322 ↗
• MalfunctionMay 22, 2026Failure to Advance; Migration

  IT WAS REPORTED THAT: "THE PHYSICIAN WAS DOING A DISTAL SPLENIC EMBOLIZATION AT AROUND 1AM. SHE MENTIONS THAT THE ANATOMY TO GET TO THE BLEED WAS QUITE TORTUOUS. SHE WAS USING A 2.0FR PROGREAT MICROCATHETER. SHE HAD ALREADY USED SEVERAL PRESTIGE COILS UP TO THIS POINT WITH NO ISSUE. THE CURRENT PRODUCT SKU INCIDENT HAS NOTHING TO DO WITH THE COIL IMPLANT ITSELF BUT THE PUSHER. SHE DEPLOYED THIS 2MM X 4CM PRESTIGE PLUS COIL IN THE LAST VESSEL AND WHEN SHE WENT TO REMOVE THE PUSHER DELIVERY SYSTEM FROM THE MICROCATHETER SHE MET A LITTLE RESISTANCE FOLLOWED BY NO RESISTANCE AT ALL, THINKING THAT EVERYTHING WAS OK. SHE TRIED TO FLUSH THE MICROCATHETER WITH SALINE, SHE NOTICED THAT THERE WAS HEAVY RESISTANCE TRYING TO FLUSH IT, THINKING THAT MAYBE THE COIL MAY NOT HAVE BEEN FULLY DEPLOYED. SHE THEN LOOKED DID A LIVE FLUORO SHOT (NO CONTRAST) TO CONFIRM THAT THE COIL WAS FULLY REMOVED. SHE TRIED A SECOND TIME TO FLUSH THE MICROCATHETER WITH SALINE, USING A BIT MORE FORCE AND FELT THE MICROCATHETER CLEAR OUT. THE PHYSICIAN THEN DECIDED TO DO ONE MORE POST EMBOLIZATION CONTRAST RUN AND NOTICED WHAT LOOKED TO BE THE DISTAL PART OF THE PUSHER DELIVERY SYSTEM. SHE NOTES THAT THE RADIOPAQUE MA

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25262096 ↗
• 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 ↗
• 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 ↗
• MalfunctionJul 23, 2025Premature Separation; Premature Separation

  IT WAS REPORTED THAT: "THE PHYSICIAN WAS PERFORMING AN EMBOLIZATION FOR AN ADBDOMEN HEMORRAGE AND WAS USING A PROGREAT 2.4F MICROCATHETER. SHE WENT TO REPOSITION THE CATHETER AND THE COIL BROKE WITHOUT MUCH TENSION. SHE HAD TO LOSE ACCESS SINCE THE COIL WAS COMPROMISED. THE COIL CAN BE RETURNED FOR INSPECTION." INCIDENT REPORT FORM SUBMITTED FOR THIS COMPLAINT INDICATES THAT NO PATIENT INJURY WAS SUSTAINED. UPDATE - ADDITIONAL INFORMATION RECEIVED FROM THE ISSUER ON 23JUN2025: "1. DID THE PROCEDURE INVOLVE TORTUOUS ANATOMY? MILD TORTUOUSITY. 2. WILL THE MICROCATHETER BE AVAILABLE FOR RETURN? NO . 3. WHERE DID THE IMPLANT PREMATURELY DETACH? (INSIDE THE AN, INSIDE THE MC? ETC) THE COIL WAS IN THE PATIENT AND HALFWAY STILL IN THE MICROCATHETER. 4. WERE ANY ATTEMPTS MADE TO DETACH THE IMPLANT COIL USING THE DETACHMENT CONTROLLER? NO. 5. CAN YOU CONFIRM IF THE DEVICE WAS IMPLANTED? DEVICE WAS REMOVED FROM PATIENT".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22583429 ↗
• 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 ↗
• MalfunctionMay 9, 2025Migration; Premature Separation; Migration; Premature Separation

  IT WAS REPORTED THAT: "PRES0865CPKPLT - IN A GONADAL CASE WITH DR (B)(6) ON (B)(6) 2025 WE USED SEVERAL PRESTIGE COILS. THE FINAL COIL THAT WE USED DEPLOYED EARLY IN THE 2.4 PROGREAT MICROCATHETER. IT SOUNDS LIKE DR (B)(6) AND THE IR TECH FELT SOME RESISTANCE DURING THE DEPLOYMENT. 70% OF THE COIL DEPLOYED CORRECTLY IN THE VESSEL BUT THE LAST 30% DEPLOYED EARLY AND DIDN'T COIL PROPERLY, THE END RESULT BEING A TAIL FLOATING IN THE RENAL VEIN ABOVE THE REST OF THE COILS IN THE GONADAL VEIN. DR (B)(6) TRIED TO PUSH THE TAIL OF THE COIL WITH A WIRE AND WITH A BALLOON BUT WAS UNABLE TO SUFFICIENTLY MOVE THE COIL. SHE FELT THAT THE COIL WAS SECURE ENOUGH AND WOULDN'T TRAVEL BECAUSE THE INITIAL 70% OF THAT COIL CORRECTLY DEPLOYED AND WAS SECURE." INCIDENT REPORT FORM SUBMITTED FOR THIS COMPLAINT INDICATES THAT NO PATIENT INJURY WAS SUSTAINED. UPDATE 11APR2025- ADDITIONAL INFORMATION RECEIVED FROM THE ISSUER: "1. ANY UPDATES ON THE PATIENT? - I REACHED OUT TO DR (B)(6) TODAY AND SHE SAID THE PATIENT WAS FINE WHEN THEY WENT HOME TUESDAY AND SHE HASN'T HEARD ANY NEWS FROM THE PATIENT SINCE THEN."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21998762 ↗
• MalfunctionApr 11, 2025Stretched; Premature Separation; Stretched; Premature Separation

  IT WAS REPORTED THAT: "WHILE DELIVERING THE COIL, THE PHYSICIAN TRIED TO RETRACT THE COIL TO REPOSITION. IT GOT STUCK. IT DETACHED STILL PARTIALLY IN THE MICROCATHETER. WHEN THE PHYSICIAN TRIED TO SNARE THE COIL, IT BEGAN TO UNRAVEL. ULTIMATELY, IT WAS ALL REMOVED. I HAVE THE COIL AND CATHETER FOR RETURN." INCIDENT REPORT FORM SUBMITTED FOR THIS COMPLAINT INDICATES THAT NO PATIENT INJURY WAS SUSTAINED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21831220 ↗
• MalfunctionFeb 7, 2025Premature Separation; Premature Separation

  IT WAS REPORTED THAT: "THE PHYSICIAN PERFORMING A BRONCHIAL AVM WITH A RENEGADE 18 MICROCATHETER 150CM WITH A BASE 5F DIAGNOSTIC CATHETER. USED ONE PRESTIGE 6X15 LE COIL WITH NO ISSUES AND WAS DEPLOYED WITHOUT ISSUE. GRABBED 1 6X35 PRESTIGE LE AND AS THE COIL ADVANCED HE SAID IT WAS GETTING HARDER TO PUSH THAT WAS RIGHT AFTER HE STEPPED ON FLURO AS THE FLURO SAVE MARKER PASSED BY. HE TRIED TO REPOSITION AND SAID THAT IT LOOKED LIKED TO PRE-DETACHED. HE GRABBED A 1CM SYRINGE TO SQUIRT THE COIL AND IT APPEARED IT WENT INTO THE COIL MASS WITHOUT ISSUE. HE GRABBED 1 MORE 6X35 PRESTIGE LE AND THIS TIME AS HE ADVANCED IT WOULD NOT ADVANCE AS THERE WAS COIL FROM THE 1ST 6X35 COIL IN THE MICROCATHETER BECAUSE THE COIL BROKE AND WAS IN A RATS NEST OF INNER COIL. HE HAD TO LOSE ACCESS AND ABORT THE CASE." UPDATE 10JAN2024 - ADDITIONAL INFORMATION RECEIVED FROM THE ISSUER: "1. HOW WOULD THE TORTUOSITY BE DESCRIBED IN THIS PROCEDURE? SEE ATTACHED PHOTOS IT WAS VERY TORTUOUS. 2. FOR COMPLAINT (B)(4), ARE WE ALSO RECEIVING THIS UNIT? NOT SURE WHY THERE ARE TWO COMPLAINTS AS IT WAS ONE CASE. I AM SENDING BACK THE RENEGADE 18 AND THE 6X15 PUSHER AND THE 6X35 PUSHER WITH NO COILS AS THEY ARE IN THE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21334321 ↗
• MalfunctionJan 9, 2025Premature Separation; Premature Separation

  IT WAS REPORTED THAT: "PRES02020CXPPL, LOT: F231100619 WAS ADVANCED INTO THE VESSEL. IT WAS DETERMINED COIL WAS SLIGHTLY OVERSIZED AND PHYSICIAN CHOSE TO GO WITH A 1MM COIL. UPON PULLING THE COIL BACK TO REMOVE IT, THE COIL DETACHED." UPDATE 10DEC2024: ADDITIONAL INFORMATION RECEIVED FROM THE ISSUER: "THE DETACHMENT OCCURRED WHEN THE COIL WAS HALF IN THE VESSEL AND HALF IN THE MICROCATHETER ROUGHLY. THEY HAD TO PULL THE MICROCATHETER OUT UNDER NEGATIVE PRESSURE WITH A SYRINGE. WHEN THEY REASSESSED THE TREATMENT VESSEL, THEY SWITCHED OVER TO PENUMBRA COILS." INCIDENT REPORT FORM SUBMITTED FOR THIS COMPLAINT INDICATES THAT NO PATIENT INJURY WAS SUSTAINED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21113418 ↗
• MalfunctionDec 27, 2024Premature Separation; Premature Separation

  IT WAS REPORTED THAT: "PRES0750HPKPL WAS DEPLOYED INTO A SPLENIC ARTERY AND WOULD NOT DETACH. 10 PLUS ATTEMPTS WERE MADE AND SECOND DETACHMENT HANDLE TO NO AVAIL. THE COIL WAS RETRACTED. DURING THE COIL BEING REMOVED IT PREMATURELY DETACHED AND SNAPPED HALF WAY DOWN THE IMPLANT. THE REST OF THE COIL IN THE MICROCATHETER WAS ATTEMPTED TO BE PUSHED IN WITH A COIL PUSHER AND WAS ULTIMATELY FLUSHED IN TO FINISH THE CASE." UPDATE 02DEC2024 - ADDITIONAL INFORMATION RECEIVED FROM THE ISSUER: "1) WAS ANY OF THE IMPLANT PROTRUDING OUT OF THE MC WHEN THE DETACHMENT HAPPENED? YES, THE COIL WAS BEING RETRACTED AND WAS HALF IN THE MC AND HALF IN THE VESSEL WHEN THE DETACHMENT HAPPENED. 2) WAS ANY ADDITIONAL DEVICES USED IN ORDER TO MOVE/RETRIEVE THE IMPLANT COIL? YES, THEY DID OPEN A COIL PUSHER TO TRY TO PUSH THE COIL THE REST OF THE WAY IN, HOWEVER IT DIDN'T WORK AND THAT IS WHY THE CHOSE TO FLUSH THE COIL IN. 3) WAS THERE ANY IMPACT TO THE PATIENT FOLLOWING THE IMPLANT COIL BEING FLUSHED INTO THE TREATMENT LOCATION? YES, THE EMBOLIZATION WAS OFF TARGET. LUCKILY, IT WAS NOT IN THE PARENT VESSEL, SO IN THIS CASE A SLIGHTLY OFF TARGET EMBOLIZATION WAS STILL ACCEPTABLE." INCIDENT REPORT FORM SUB

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21027267 ↗
• MalfunctionDec 12, 2024Migration; Premature Separation; Migration; Premature Separation

  IT WAS REPORTED THAT: "THE PHYSICIAN WAS PERFORMING A FONTAN EMBOLIZATION USING A 2.4 PROGREAT MICROCATHETER AND THE 1.5 X 6CM COIL WAS ABOUT 80% OUT WHEN IT BALLED UP IN THE DISTAL TIP. HE PULLED THE MICROCATHETER BACK INTO THE 4F GLIDECATH TO HAVE THE COIL UNLODGE BUT THEN PROLAPSED INSIDE THE 4F GLIDECATH. AFTER WIRE MANIPULATION AND PUSHING THE COIL FINALL POPPED OUT TO TRAVEL INTO A SIDE BRANCH LEAVING A LONG TAIL. HE FINALLY COILED THAT BRANCH AND WAS ABLE TO JAIL THE COIL SO IT WOULD NOT MOVE. HE SAID THE COIL GOT STUCK IN THE MICRO AND HE SHOULD HAVE FLUSHED IT OUT FIRST BEFORE PULLING THE MICRO INTO THE GLIDECATH." UPDATE 15NOV2024 - ADDITIONAL INFORMATION RECEIVED FROM THE ISSUER: "PATIENT IS SATISFACTORY AND WAS DISCHARGED." INCIDENT REPORT FORM SUBMITTED FOR THIS COMPLAINT INDICATES THAT NO PATIENT INJURY WAS SUSTAINED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20914344 ↗

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