HyperForm 104-4470 (UDI 00836462004184)Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00836462004184), received between May 27, 2020 and Jan 20, 2026 — classified as 1 death, 10 malfunctions.

The most frequently reported specific device problem is “Burst Container or Vessel” (6 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• 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 ↗
• 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 ↗
• MalfunctionSep 23, 2024Burst Container or Vessel; Burst Container or Vessel

  ADDITIONAL INFORMATION RECEIVED THAT WHEN ASKED IF THE PHYSICIAN TEST THE BALLOON PRIOR TO USE, THE REP STATED THE PHYSICIAN PERFORMED AS PROCEDURE. THE BALLOON PERFORMED AS INTENDED DURING TESTING. THE GUIDEWIRE TIP WAS ADVANCED OUT OF THE CATHETER TIP 3MM TO 5 MM DURING THE INFLATION. THE CONTRAST RATIO WAS A DILUTION RATE, IT'S HALF. THE PHYSICIAN SLIGHTLY SHAPED THE GUIDEWIRE TIP. THE BALLOON GOT INFLATED AND DEFLATED ZERO TIMES. THE INJECTION RATE WAS STEADY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20288382 ↗
• MalfunctionMar 12, 2024Device Damaged by Another Device; Device Damaged by Another Device

  MEDTRONIC RECEIVED A REPORT THAT AN EVENT IN WHICH 10 GUIDEWIRE WAS PROTRUDING FROM THE HYPERFORM BALLOON DURING PREPARATION AT 10 GUIDEWIRE DURING TREATMENT. NO PATIENT SYMPTOMS OR FURTHER COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18888355 ↗
• MalfunctionAug 28, 2023Burst Container or Vessel; Burst Container or Vessel

  MEDTRONIC RECEIVED A REPORT THAT DURING PREPARATION, IT WAS FOUND THAT THE CONTRAST AGENT WAS LEAKING FROM THE HYPERFORM BALLOON SO IT WAS REPLACED WITH A NEW ONE FOR PRECAUTION. NO PATIENT SYMPTOMS OR FURTHER COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17638638 ↗
• MalfunctionNov 29, 2022Inflation Problem; Leak/Splash; Inflation Problem; Leak/Splash

  MEDTRONIC RECEIVED A REPORT THAT THE BALLOON WAS OCCLUDED. THE HYPERFORM47 WAS SELECTED FOR IC-4MM BAC CASE. IT WAS CONFIRMED THAT T HERE WAS NO DAMAGE TO THE OUTER BOX, SO IT WAS OPENED. THE PREPARATION AND AIR REMOVAL WERE PERFORMED AS PER THE PACKAGE INSERT, BUT DURING THE TEST INFLATION, THE BALLOON DID NOT EXPAND NORMALLY. THE SUPPLIED X-PEDION WAS USED AS PER THE PACKAGE INSERT. AS PER THE PACKAGE INSERT, IT WAS SHIELDED WITHIN 10 CM OF X-PEDION TIP PART. HOWEVER, WHEN THE BALLOON WAS CLOSELY LOOKED, IT WAS CONFIRMED THAT THE CONTRAST AGENT LEAKED FROM THE BALLOON. AFTER THAT, A NEW NON-MEDTRONIC BALLOON/TRANSFORM PRODUCT WAS OPENED AND THE PROCEDURE WAS PERFORMED SUCCESSFULLY. NO PATIENT SYMPTOMS OR FURTHER COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15877120 ↗
• MalfunctionOct 31, 2022Leak/Splash; Leak/Splash

  ADDITIONAL INFORMATION WAS RECEIVED. THE DEVICE WAS PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU) (INSPECTION ,HYDRATION, ETC.). THE CAUSE OF THE CONTRAST LEAK WAS NOT DETERMINED. THE DETACHABLE INJECTION PORT WAS NOT USED. THE PHYSICIAN TESTED THE BALLOON PRIOR TO USE. IT IS UNKNOWN IF THE BALLOON PERFORMED AS INTENDED DURING TESTING. IT IS UNKNOWN HOW FAR THE GUIDEWIRE TIP WAS ADVANCED OUT OF THE CATHETER TIP DURING THE INFLATION. THE BALLOON LEAK WAS LOCATED IN THE MIDDLE SEGMENT. THE CONTRAST RATIO WAS 50:50. THE PHYSICIAN DID NOT SHAPE THE GUIDEWIRE. IT IS UNKNOWN HOW MANY TIMES THE BALLOON INFLATED AND DEFLATED. THE INJECTION RATE WAS STEADY. IT IS UNKNOWN WHAT TYPE OF SYRINGE WAS USED DURING INFLATION/DEFLATION OF THE BALLOON.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15705480 ↗
• MalfunctionMar 8, 2022Burst Container or Vessel; Burst Container or Vessel

  MEDTRONIC RECEIVED A REPORT THAT WHEN THE HYPERFORM BALLOON WAS INFLATED FOR PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA), RUPTURE WAS NOTED AND THE PRODUCT WAS REMOVED OUT OF PATIENT'S BODY. THE PRODUCT WAS DISPOSED BY THE FACILITY BECAUSE THE PATIENT WAS SUSPECTED TO HAVE AN INFECTION. THE BALLOON WAS REPLACED, AND THE PATIENT DID NOT EXPERIENCE ANY INJURY OR COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13689524 ↗
• DeathMay 27, 2020Deflation Problem; Deflation Problem

  ADDITIONAL INFORMATION: THE DEVICES WILL BE RETURNED IN THE FUTURE. THERE ARE NO IMAGES TO PROVIDE. A 1ML SYRINGE WAS USED. THE BALLOON WAS FLUSHED AS PER THE INSTRUCTIONS FOR USE (IFU). THERE WAS NO FRICTION OR DIFFICULTY DURING THE INFLATION. THE ISSUE THE COIL DETACHED WITHIN THE CATHETER AND THEN CAME OUT OF THE CATHETER. AS THE BALLON FAILED TO DEFLATE DURING PREPARATION, IT WAS NOT USED DURING THE PROCEDURE AND DID NOT CONTRIBUTE TO PATIENT DEATH.

  Patient problems: Death; No Known Impact Or Consequence To Patient

  MAUDE report 10092530 ↗