HyperFormRecalls & reported problems across all models

We found 7 models of HyperForm by Micro Therapeutics, Inc. in the FDA's device registry (GUDID). Together they are named in 46 adverse event reports in the FDA's MAUDE database, received between Sep 18, 2019 and Aug 31, 2026 — classified as 1 death, 2 injuries, 43 malfunctions.

The most frequently reported specific device problem is “Burst Container or Vessel” (24 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. 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

Most reported HyperForm problems

HyperForm models

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

• HyperForm 104-4770

  Catheter, intravascular occluding, temporary
  11 reports
• HyperForm 104-4470

  Catheter, intravascular occluding, temporary
  1 death11 reports
• HyperForm 104-4715

  Catheter, intravascular occluding, temporary
  8 reports
• HyperForm 104-4470

  Catheter, intravascular occluding, temporary
  6 reports
• HyperForm 104-4420

  Catheter, intravascular occluding, temporary
  4 reports
• HyperForm 104-4770

  Catheter, intravascular occluding, temporary
  4 reports
• HyperForm 104-4415

  Catheter, intravascular occluding, temporary
  2 reports

Recent HyperForm adverse event reports

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

• MalfunctionAug 31, 2026Deflation Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50519967 ↗
• MalfunctionMar 2, 2026Burst Container or Vessel

  MEDTRONIC RECEIVED A REPORT THAT THE PREPARATION WAS PERFORMED ACCORDING TO THE PACKAGE INSERT, BUT HYPER FORM BALLOON DAMAGE WAS OBSERVED, SO THE PRODUCT WAS REPLACED WITH A NON-MEDTRONIC DEVICE AND THE TREATMENT WAS SUCCESSFULLY COMPLETED. THERE WAS NO SUPERVISION AND NO HEALTH DAMAGE. THE PATIENT DID NOT HAVE ANY SYMPTOMS OR COMPLICATIONS RELATED TO THIS EVENT. ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THE CAUSE OF THE EVENT WAS NOT DETERMINED. THE EVENT OCCURRED DURING SETUP PRIOR TO USE. THE REPORTED BALLOON DAMAGE WAS IDENTIFIED AS A RUPTURE, WHICH OCCURRED NEAR THE TIP OF THE BALLOON.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24489341 ↗
• MalfunctionJan 20, 2026Burst Container or Vessel; Inflation Problem

  ADDITIONAL INFORMATION RECEIVED. THE PATIENT WAS UNDERGOING TREATMENT FOR A SACCULAR RIGHT CA ANEURYSM, APPROXIMATELY 5 MM, WITH NORMAL VESSEL TORTUOSITY. THE DEVICE WAS PREPARED AS INDICATED IN THE IFU, INCLUDING INSPECTION AND HYDRATION. THE CAUSE OF THE BALLOON LEAK WAS NOT DETERMINED. DURING THE TEST SET UP, THE GUIDEWIRE TIP WAS ADVANCED APPROXIMATELY 3 CM OUT OF THE CATHETER TIP, AND THE CONTRAST RATIO USED WAS 50%. THE BALLOON WAS INFLATED ONCE OUTSIDE THE BODY AND TWICE INSIDE, USING A MEDALLION 1ML SYRINGE AT A STEADY INJECTION RATE.THE LOCATION OF THE BALLOON LEAK WAS UNKNOWN, AND THE PHYSICIAN DID NOT SHAPE THE GUIDEWIRE TIP. DURING THE PROCEDURE, GUIDEWIRE MANIPULATION WAS NORMAL, AND AN XPEDION GUIDEWIRE WAS USED, WITH THE TIP ADVANCED ABOUT 3 MM OUT OF THE CATHETER TIP DURING INFLATION. THE CONTRAST RATIO WAS 50% AND INJECTION WAS STEADY. BOTH THE BALLOON AND XPEDION GUIDEWIRE WERE HYDRATED AS INDICATED IN THE IFU. BALLOON DEFLATION WAS PERFORMED USING A 1ML MEDALLION TO APPLY NEGATIVE PRESSURE, WITH THE GUIDEWIRE ADVANCED APPROXIMATELY 3 CM OUT OF THE CATHETER TIP. IT IS UNKNOWN WHETHER THE CATHETER AND GUIDEWIRE WERE INSPECTED FOR BALLOON PERFORMANCE OR CLOT PRESENC

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24116038 ↗
• MalfunctionNov 20, 2025Burst Container or Vessel; Inflation Problem; Packaging Problem; Burst Container or Vessel; Inflation Problem; Packaging Problem

  MEDTRONIC RECEIVED A REPORT THAT A HOLE WAS FOUND IN THE HYPERFORM BALLOON DURING PREPARATION. IMMEDIATELY AFTER AIR WAS RELEASED ACCORDING TO THE INSTRUCTIONS FOR USE AT THE TIME OF OPENING, THE BALLOON DID NOT EXPAND. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23610403 ↗
• MalfunctionNov 19, 2025Burst Container or Vessel; Burst Container or Vessel

  ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THE VESSEL TORTUOSITY WAS NORMAL. THE DEVICE WAS PREPARED AS INDICATED IN THE IFU (INSPECTION ,HYDRATION, ETC.). THE PROCEDURE WAS COMPLETED USING ANOTHER PRODUCT. LEAKAGE OCCURRED DURING SET UP. THE ISSUE WAS DISCOVERED DURING IN VITRO TESTING. THE CAUSE OF THE LEAK WAS NOT DETERMINED. THE BALLOON PERFORMED AS INTENDED DURING TESTING. THE GUIDEWIRE TIP WAS ADVANCED 7CM OUT OF THE CATHETER TIP DURING THE INFLATION. BALLOON LEAK WAS AT THE TIP. THE PHYSICIAN DID NOT SHAPE THE GUIDEWIRE TIP. THE BALLOON WAS INFLATED AND DEFLATED 1 TIME. INJECTION RATE WAS SLOW. A 1ML SYRINGE WAS USED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23593894 ↗
• MalfunctionNov 17, 2025Deflation Problem; Deflation Problem

  ADDITIONAL INFORMATION WAS RECEIVED. VESSEL TORTUOSITY WAS ASSESSED AS MODERATE. THE DEVICE WAS PREPARED ACCORDING TO THE IFU, INCLUDING INSPECTION AND HYDRATION. THE CAUSE OF THE EVENT IS UNKNOWN. THE PHYSICIAN TESTED THE BALLOON PRIOR TO USE, AND IT PERFORMED AS INTENDED DURING TESTING. IODINATED ALCOHOL WAS USED AS THE CONTRAST AGENT. THE GUIDEWIRE TIP WAS ADVANCED MORE THAN 3 CM OUT OF THE CATHETER TIP DURING INFLATION, AND A 1 ML SYRINGE WAS USED FOR BALLOON INFLATION AND DEFLATION. IT IS UNKNOWN WHETHER BLOOD REFLUXED INTO THE BALLOON LUMEN. NO FRICTION OR DIFFICULTY WAS ENCOUNTERED DURING INFLATION. AFTER MULTIPLE INFLATIONS, THE CATHETER AND GUIDEWIRE WERE EXAMINED FOR CLOT AT THE TIP OR INFLATION HOLES, AND NO THROMBOSIS WAS FOUND. NO EXTENSIVE GUIDEWIRE MANIPULATION OCCURRED DURING THE PROCEDURE. NO KINK OR DAMAGE WAS OBSERVED ON EITHER THE CATHETER OR THE GUIDEWIRE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23569561 ↗
• MalfunctionNov 11, 2025Inflation Problem; Inflation Problem

  MEDTRONIC RECEIVED A REPORT THAT THE AXIUM COIL WAS STRETCHED. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SACCULAR, UNRUPTURED ANEURYSM IN THE INTERNAL CAROTID ARTERY WITH A MAX DIAMETER OF 9 MM AND A 5 MM NECK DIAMETER. THE ACCESS VESSEL WAS THE FEMORAL ARTERY. IT WAS NOTED THE PATIENT'S BLOOD FLOW WAS NORMAL AND VESSEL TORTUOSITY WAS NORMAL. IT WAS REPORTED THAT THE AXIUM COIL WAS STRETCHED AND REPLACED AND THEN THE NEW COIL WAS IMPLANTED SMOOTHLY. AFTER THE ECHELON MICROCATHETER WAS SHAPED, IT WAS FOUND THAT THE TIP OF THE MICROCATHETER WAS DAMAGED. AFTER REPLACEMENT, THE OPERATION WAS SUCCESSFULLY COMPLETED. THE GUIDEWIRE COULD NOT PASS THROUGH THE ECHELON MICROCATHETER, AND THE OPERATION WAS SUCCESSFUL AFTER IT WAS REPLACED; THE GUIDEWIRE WAS OF ANOTHER BRAND. DURING HYPERFORM BALLOON PREPARATION, AIR LEAKAGE WAS DETECTED. THE REPORTED DEVICE AND ANY ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). THE CATHETER WAS FLUSHED PER THE IFU. NO PATIENT SYMPTOMS OR COMPLICATIONS WERE ASSOCIATED WITH THIS EVENT. ANCILLARY DEVICES INCLUDE 2 ECHELON CATHETERS, A HYPER FORM BALLOON AND AN ADDITIONAL AXIUM COIL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23525971 ↗
• MalfunctionJul 21, 2025Inflation Problem; Leak/Splash; Inflation Problem; Leak/Splash

  MEDTRONIC RECEIVED A REPORT THAT THE BALLOON WAS PRE-FILLED IN VITRO, LEAKED AIR, AND THE OPERATION WAS SUCCESSFULLY COMPLETED AFTER REPLACEMENT. IT WAS UNKNOWN WHETHER THE REPORTED DEVICE AND ANY ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). NO PATIENT SYMPTOMS OR COMPLICATIONS WERE ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22555804 ↗
• MalfunctionJul 14, 2025Burst Container or Vessel; Inflation Problem; Burst Container or Vessel; Inflation Problem

  ADDITIONAL INFORMATION RECEIVED REPORTED THE BALLOON RUPTURED. DURING PROCEDURE, WAS THERE NOT EXTENSIVE GUIDEWIRE MANIPULATION. ITS OWN GUIDEWIRE X-PEDION WAS USED WITH THE BALLOON. DURING THE INFLATION, THE GUIDEWIRE TIP ADVANCED 10CM OUT OF THE CATHETER TIP. THE GUIDEWIRE TIP WAS NOT SHAPED. 50:50 CONTRAST RATIO WAS USED. THE INJECTION RATE WAS SLOW. WITHDREW THE GUIDEWIRE TO DEFLATE THE BALLOON. IT WAS NOT INFLATED MULTIPLE TIMES. BLOOD DID NOT ENTER THE CATHETER LUMEN. CONTRAST AGENT LEAKAGE WAS FOUND. THE CATHETER WAS NOT KINKED. THE BALLOON WAS TESTED IN VITRO. THE BALLOON PERFORMED AS INTENDED. A CARTRIDGE SYRINGE WAS USED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22493401 ↗
• MalfunctionJul 9, 2025Burst Container or Vessel; Burst Container or Vessel

  MEDTRONIC RECEIVED A REPORT THAT THE PATIENT WAS PLANNED TO UNDERGO EMBOLIZATION OF A RIGHT LENTICULOSTRIATE ARTERY ANEURYSM USING THIS CONSUMABLE. OCCLUSION OF THE MIDDLE CEREBRAL ARTERY WAS INTENDED TO FACILITATE THE EMBOLIZATION. DURING BALLOON INFLATION, THE BALLOON BURST. HEALTHCARE PROVIDER (HCP) REPLACED IT WITH ANOTHER BALLOON FOR USE TO COMPLETE THE PROCEDURE. THIS EVENT SERIOUSLY AFFECTED THE PROGRESS OF SURGERY. NO PATIENT SYMPTOMS OR FURTHER COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. THE PATIENT WAS UNDERGOING SURGERY FOR VESSEL OCCLUSION TREATMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22459891 ↗
• MalfunctionJun 24, 2025Burst Container or Vessel; Inflation Problem; Burst Container or Vessel; Inflation Problem

  MEDTRONIC RECEIVED A REPORT THAT BECAUSE PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) WAS PERFORMED AFTER PIPELINE (PED2-450-20) PLACEMENT, THE BALLOON WAS NOT CONTRAST-ENHANCED WHEN THE HYPERFORM WAS INSERTED AND EXPANDED IN ACCORDANCE WITH THE PIPELINE'S STENT DISTAL. THERE WAS NO RESISTANCE FELT DURING INFLATION, AND UPON REMOVAL, AN ATTEMPT WAS MADE TO EXPAND THE BALLOON OUTSIDE THE BODY, BUT CONTRAST MEDIUM WAS LEAKING FROM THE BALLOON. PREPARATION WAS PERFORMED AS PER THE PACKAGE INSERT PRIOR TO INSERTION, BUT THERE WERE NO PROBLEMS WITH THE EXPANSION AND CONTRACTION. NO PATIENT SYMPTOMS OR FURTHER COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22320105 ↗
• MalfunctionMay 29, 2025Burst Container or Vessel; Burst Container or Vessel

  ADDITIONAL INFORMATION WAS RECEIVED REPORTING THE FIRST BALLOON BURST, SO WE REPLACED IT WITH THE SECOND ONE. THE SECOND ONE BURST AGAIN, SO WE REPLACED IT WITH THE THIRD ONE. THEN THE OPERATION WAS SUCCESSFULLY COMPLETED. THE CAUSE OF THE BURSTS WAS NOT DETERMINED. BECAUSE THE BALLOON HAD BEEN DISCARDED IT WAS UNCLEAR WHERE WAS THE BALLOONS' LEAK WAS. NO CARTRIDGE SYRINGES WERE USED, AND IT WAS UNCLEAR WHAT SYRINGES WERE USED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22107003 ↗
• MalfunctionMar 10, 2025Burst Container or Vessel; Inflation Problem; Burst Container or Vessel; Inflation Problem

  ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THE CAUSE OF THE BALLOON BEING BROKEN WAS NOT DETERMINED. THE PHYSICIAN TESTED THE BALLOON PRIOR TO USE. THE BALLOON DID NOT PERFORM AS INTENDED DURING TESTING. THE PHYSICIAN SHAPED THE GUIDEWIRE TIP. THE INJECTION RATE WAS STEADY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21562386 ↗
• MalfunctionFeb 10, 2025Burst Container or Vessel; Inflation Problem; Burst Container or Vessel; Inflation Problem

  ADDITIONAL INFORMATION RECEIVED REPORTED A SELF-CONTAINED GUIDEWIRE WAS USED. THE GUIDEWIRE WAS ADVANCED 1 CM OUT OF THE CATHETER TIP. THE GUIDEWIRE TIP WAS NOT SHAPED. THE INJECTION RATE WAS STEADY. USED CARTRIDGE SYRINGE TO ASPIRATE OUT AND DEFLATE BALLOON. THE GUIDEWIRE WAS 7MM FROM THE CATHETER TIP DURING INFLATION/DEFLATION. AFTER MULTIPLE INFLATIONS, THE CATHETER AND GUIDEWIRE EAS NOT REMOVED OR INSPECTED. BLOOD DID NOT ENTER THE CATHETER LUMEN. CONTRAST WAS OBSERVED LEAKING DURING THE INFLATION ATTEMPT. THE CATHETER WAS NOT KINKED. THE PHYSICIAN TESTED THE BALLOON PRIOR TO USE.THE BALLOON DID NOT PERFORM AS INTENDED DURING TESTING. THE BALLOON LEAK WAS AT THE TIP, CONTRAST RATION WAS 50/50. THE BALLOON GAT INFLATED AND DEFLATED 3 TIMES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21344643 ↗
• MalfunctionOct 11, 2024Inflation Problem; Leak/Splash; Physical Resistance/Sticking; Inflation Problem; Leak/Splash; Physical Resistance/Sticking

  ADDITIONAL INFORMATION WAS RECEIVED. GUIDEWIRE MANIPULATION WAS USED WITHIN THE RANGE OF ABOUT 1-8 CM. THE GUIDEWIRE THAT WAS USED WITH THE BALLOON WAS NON-MEDTRONIC. DURING THE INFLATION, THE GUIDEWIRE TIP WAS ADVANCED OUT OF THE CATHETER TIP WITHIN ABOUT 8 CM. THE PHYSICIAN SHAPED THE GUIDEWIRE TIP INTO A J-SHAPE. CONTRAST RATIO THAT WAS USED WAS 50/50. INJECTION RATE WAS STEADY. THE BALLOON WAS FLUSHED AS INDICATED IN THE IFU. IT IS UNKNOWN IF THE GUIDEWIRE HYDRATED FOR MORE THAN 30 SECONDS. A NORMAL IN-DEF WITH A SYRINGE WAS DONE TO DEFLATE THE BALLOON. IT WAS CONFIRMED THAT THE CATHETER AND GUIDEWIRE WAS REMOVED OUT OF THE BODY, BUT IT SEEMS THAT NO BLOOD CLOT ADHESION HAS BEEN CONFIRMED. IT IS UNKNOWN IF BLOOD ENTERED THE CATHETER LUMEN. IT SEEMED THAT IT WAS A LITTLE DIFFICULT TO GUIDE DURING THE CATHETER OPERATION, BUT A KINK WAS NOT CONFIRMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20428917 ↗

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