SYNERGY MEGATRON™ H7493942832450Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 08714729985792), received between Jun 5, 2022 and Apr 28, 2026 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Difficult to Remove” (4 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.

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 28, 2026Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE PATIENT PRESENTED WITH ST-ELEVATION MYOCARDIAL INFARCTION AND UNDERWENT PERCUTANEOUS CORONARY INTERVENTION. THE TARGET LESION WAS LOCATED IN THE MODERATE TO SEVERELY CALCIFIED VESSEL. A 4.50 X 32MM SYNERGY MEGATRON DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT. HOWEVER, DURING THE INFLATION FOR STENT EXPANSION AT SUB NOMINAL PRESSURE, THE STENT BALLOON BURST. THE DEVICE WAS REMOVED AND THERE WERE NO DEVICE FRAGMENTS LEFT INSIDE THE PATIENT'S BODY. THE STENT WAS RE-PREPPED, AND THE RUPTURED STENT BALLOON WAS NOTED. THE PROCEDURE WAS COMPLETED WITH AN ALTERNATE STENT OF SIMILAR DIAMETER AND LENGTH. THERE WERE NO PATIENT COMPLICATIONS AND THE PATIENT FULLY RECOVERED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25023712 ↗
• MalfunctionAug 7, 2025Failure to Deflate; Failure to Deflate

  IT WAS REPORTED THAT DEFLATION ISSUE OCCURRED. THE PATIENT PRESENTED WITH A CORONARY ARTERY DISEASE. A 4.50 X 32MM SYNERGY MEGATRON DRUG-ELUTING STENT WAS ADVANCED AND DEPLOYED. POST DEPLOYMENT, THE STENT DELIVERY SYSTEM BALLOON WOULD NOT DEFLATE. THE STENT BALLOON WAS REMOVED AND REPLACED; AND THE PROCEDURE WAS COMPLETED. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22745695 ↗
• MalfunctionJul 5, 2024Difficult to Remove; Difficult to Remove

  IT WAS REPORTED VIA USER MEDWATCH MW5155116 THAT CATHETER DIFFICULTY REMOVAL OCCURRED. A 4.50 X 32 MM SYNERGY MEGATRON DRUG-ELUTING STENT WAS DEPLOYED SUCCESSFULLY. HOWEVER, DURING THE REMOVAL OF THE STENT DELIVERY SYSTEM, IT BECAME DIFFICULT TO REMOVE FROM THE PATIENT'S BODY. THE PROCEDURE WAS COMPLETED WITH THE ORIGINAL DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19681399 ↗
• MalfunctionJul 3, 2024Difficult to Remove; Difficult to Remove

  IT WAS REPORTED VIA USER MEDWATCH MW5155117 THAT CATHETER REMOVAL DIFFICULTY OCCURRED. THE PATIENT PRESENTED WITH A ST-SEGMENT ELEVATION MYOCARDIAL INFARCTION (STEMI). THE 70% STENOSED TARGET LESION WAS LOCATED IN THE MINIMALLY TORTUOUS AND NON-CALCIFIED RIGHT CORONARY ARTERY. THROMBUS WAS NOTED AND A 4.50 X 32MM SYNERGY MEGATRON DRUG-ELUTING STENT WAS DEPLOYED FOR 30 SECONDS AT 20 ATMOSPHERES. HOWEVER, UPON DEFLATION, THE STENT BALLOON BECAME DIFFICULT TO REMOVE. THE PHYSICIAN THEN PULLED BACK NEGATIVELY TWICE, DEFLATED THE BALLOON FOR 69 SECONDS, AND SUCCESSFULLY REMOVED IT. THE STENT BALLOON DID NOT PULL THROUGH THE GUIDE AND EVERYTHING HAD TO BE REMOVED. THE PROCEDURE WAS COMPLETED WITHOUT AFFECTING PATIENT CARE BUT DID DELAY FURTHER NECESSARY STENTING. THE STENT ITSELF WAS DEPLOYED WITHOUT ISSUE. THE PATIENT RETURNED TO THE FLOOR WITH TIMI 3 FLOW. NO OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19671773 ↗
• MalfunctionFeb 7, 2023Difficult to Remove; Material Integrity Problem; Difficult to Remove; Material Integrity Problem

  IT WAS REPORTED THAT REMOVAL DIFFICULTIES WERE ENCOUNTERED. THE PATIENT PRESENTED FOR PERCUTANEOUS CORONARY INTERVENTION IN A SAPHENOUS VEIN GRAFT. AFTER INSERTING A 6F SHEATH AND PLACING A 6F GUIDE CATHETER, A 4.50 X 32MM SYNERGY MEGATRON DRUG-ELUTING STENT WAS ADVANCED AND DEPLOYED. HOWEVER, DURING WITHDRAWAL, THE STENT BALLOON WOULD NOT REWRAP TIGHT ENOUGH TO FIT THROUGH THE GUIDE CATHETER OPENING. AFTER A STRUGGLE TO GET IT THROUGH THE GUIDE CATHETER, IT WOULD THEN NOT FIT THROUGH THE SHEATH. THE PHYSICIAN "SNAPPED" THE BALLOON THROUGH THE SHEATH AND WAS THEN ABLE TO REMOVE IT. THE SAME SCENARIO HAPPENED WITH THE SECOND 4.50 X 32MM SYNERGY MEGATRON DRUG-ELUTING STENT DEPLOYED. THE PHYSICIAN NEEDED TO DEPLOY A THIRD SYNERGY MEGATRON DRUG-ELUTING STENT AND UPSIZED TO 8F. THE PROCEDURE WAS COMPLETED WITH NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16313725 ↗
• MalfunctionFeb 7, 2023Difficult to Remove; Material Integrity Problem; Difficult to Remove; Material Integrity Problem

  IT WAS REPORTED THAT REMOVAL DIFFICULTIES WERE ENCOUNTERED. THE PATIENT PRESENTED FOR PERCUTANEOUS CORONARY INTERVENTION IN A SAPHENOUS VEIN GRAFT. AFTER INSERTING A 6F SHEATH AND PLACING A 6F GUIDE CATHETER, A 4.50 X 32MM SYNERGY MEGATRON DRUG-ELUTING STENT WAS ADVANCED AND DEPLOYED. HOWEVER, DURING WITHDRAWAL, THE STENT BALLOON WOULD NOT REWRAP TIGHT ENOUGH TO FIT THROUGH THE GUIDE CATHETER OPENING. AFTER A STRUGGLE TO GET IT THROUGH THE GUIDE CATHETER, IT WOULD THEN NOT FIT THROUGH THE SHEATH. THE PHYSICIAN "SNAPPED" THE BALLOON THROUGH THE SHEATH AND WAS THEN ABLE TO REMOVE IT. THE SAME SCENARIO HAPPENED WITH THE SECOND 4.50 X 32MM SYNERGY MEGATRON DRUG-ELUTING STENT DEPLOYED. THE PHYSICIAN NEEDED TO DEPLOY A THIRD SYNERGY MEGATRON DRUG-ELUTING STENT AND UPSIZED TO 8F. THE PROCEDURE WAS COMPLETED WITH NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16313723 ↗
• MalfunctionJun 5, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT A STENT DISLODGED. A PERCUTANEOUS CORONARY INTERVENTION (PCI) WAS PERFORMED ON A TORTUOUS CIRCUMFLEX (CX). A GUIDEZILLA, A 3.00MM X 40MM APEX BALLOON, AND A 4.50 X 32MM SYNERGY MEGATRON STENT WERE SELECTED FOR TREATMENT. HOWEVER, THE STENT CAME OFF THE BALLOON, AND THE BALLOON WAS NOTED TO BE SHEARED. THE DEVICES WERE REMOVED FROM THE PATIENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS RESULTED IN RELATION TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14599684 ↗