Empira™ RX PTCA Dilatation Catheter 85R12250SRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00812917020237), received between Nov 3, 2020 and Nov 3, 2020 — classified as 2 deaths.

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• DeathNov 3, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED, THE PATIENT WAS FIRST ADMITTED AND IMPLANTED WITH 3.5 X 24 UNKNOWN STENT FROM LEFT MARGINAL (LM) TO LEFT ANTERIOR DESCENDING (LAD) AND THE OPENING OF THE LEFT CIRCUMFLEX (LCX) WAS 50-60% STENOSIS. THE OPERATION USED A RESTRAINED BALLOON AND KISS TECHNIQUE. POST-OPERATIVE ANGIOGRAPHY SHOWED 80% LAD STENOSIS WAS RESOLVED. FOUR MONTHS THIRTEEN DAYS POST UNKNOWN STENT IMPLANTATION; THE PATIENT HAD RECURRENT CHEST PAIN. AN ANGIOGRAPHY SHOWED, LM ARTERY WAS UNOBSTRUCTED, THE MIDDLE LAD ARTERY HAD 90% STENOSIS AND THE LCX ARTERY HAD 80% STENOSIS. INITIALLY, THE DOCTOR¿S STRATEGY WAS TO USE A CONVENTIONAL BALLOON DILATATION. BEFORE THE OPERATION, HE RECOMMENDED THAT THE PATIENT BE TREATED WITH A MEDICINE BALLOON AT THE OPENING OF LCX, BUT THE FAMILY CONSIDERS ECONOMIC FACTORS, IT WAS NOT USED. LATER, THE DOCTOR PLANNED TO USE BALLOON DILATATION IN THE LAD TO SEE THE SITUATION. DURING THE OPERATION, A 2.50 X 12 EMPIRA RAPID EXCHANGE (RX) PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA) BALLOON CATHETER EXPANDS THE LAD STENT AT 10 ATMOSPHERES (ATM) AND 14 ATM. THE STENOSIS WAS RESOLVED, THROMBOLYSIS IN MYOCARDIAL INFARCTION (TIMI) BLOOD FLOW WAS LEVEL 3 AND THEN THE EMPIRA

  Patient problems: Air Embolism; Thrombosis

  MAUDE report 10782072 ↗
• DeathNov 3, 2020Adverse Event Without Identified Device or Use Problem

  1. THE PATIENT WAS ADMITTED TO THE HOSPITAL FOR THE FIRST TIME ON (B)(6) 2020: A 3.5×24 STENT IS INSERTED FROM LM TO LAD, AND THE OPENING OF LCX IS 50-60% STENOSIS. THIS OPERATION USING RESTRAINED BALLOON AND KISS TECHNIQUE. POSTOPERATIVE ANGIOGRAPHY SHOWED: LAD 80% STENOSIS RESOLVED. 2. ON (B)(6) 2020, THE SECOND OPERATION. THE MAIN COMPLAINT OF THE PATIENT: RECURRENT CHEST PAIN, OUT-OF-HOSPITAL ECG (DECREASED ST SEGMENT, INCREASED TROPONIN); ANGIOGRAPHY RESULT: THE LAST TIME THE STENT WAS PLACED ON (B)(6) (ONE STENT WAS PLACED ON BOTH LM AND LAD), THIS ANGIOGRAPHY SHOWED: LM IS UNOBSTRUCTED, THE MIDDLE OF LAD IS 90% STENOSIS, AND LCX IS 80% STENOSIS. (DOCTOR GAVE PATIENTS FEEDBACK: DIABETES, BLOOD SUGAR CONTROL IS NOT GOOD, TIRED RECENTLY ETC.). DOCTOR STRATEGY: PREPARE TO USE CONVENTIONAL BALLOON DILATATION. BEFORE THE OPERATION, HE RECOMMENDED THAT THE PATIENT BE TREATED WITH A MEDICINE BALLOON AT THE OPENING OF LCX, BUT THE FAMILY CONSIDERS ECONOMIC FACTORS, DIDN'T USE. LATER, THE DOCTOR PLANS TO USE BALLOON DILATATION IN LAD TO SEE THE SITUATION. DURING THE OPERATION: THE 2.5×12 EMPIRA BALLOON (10ATM, 14ATM) EXPANDS THE LAD STENT, THE STENOSIS IS RESOLVED, THE TIMI BLOOD FLOW

  Patient problems: Chest Tightness/Pressure; Death; Thrombus

  MAUDE report 10777444 ↗