Empira™ NC RX PTCA Dilatation Catheter 75R10350NRecalls & reported problems
Tactx Medical, Inc. · Empira™ NC RX PTCA Dilatation Catheter · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00812917020855), received between Jun 18, 2020 and Jun 18, 2020 — classified as 1 injury.
The most frequently reported specific device problem is “Burst Container or Vessel” (1 report).
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
Device problems
- Burst Container or Vessel1
- Detachment of Device or Device Component1
- Material Separation1
Patient problems
- No Consequences Or Impact To Patient1
- No Information1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJun 18, 2020Burst Container or Vessel; Material Separation; Detachment of Device or Device Component; Burst Container or Vessel; Material Separation; Detachment of Device or Device Component
THE FOLLOWING COMPLAINT EVENT DESCRIPTION WAS RECEIVED AT CREGANNA MEDICAL; RECEIVED ON 19-MAY-2020: AS REPORTED THAT THE BALLOON WAS BURST WHEN THE BALLOON HITS 16 ATM. ADDITIONAL INFORMAITON RECEIVED ON 26-MAY-2020: THE BALLOON IS COMPLETELY SEPARATED FROM THE DELIVERY SHAFT (IMAGE 1 AND 2). THE BALLOON'S BODY IS REMOVED FROM PATIENT'S BODY BY SURGERY.
Patient problems: No Consequences Or Impact To Patient; No Information
MAUDE report 10167926 ↗
Other Catheters, Transluminal Coronary Angioplasty, Percutaneous devices
- MINI TREK™ 1012270-15Abbott Vascular Inc. · Catheters, transluminal coronary angioplasty, percutaneous223 reports
- Maverick²™ H7493892815200Boston Scientific Corporation · Catheters, transluminal coronary angioplasty, percutaneous1 death203 reports
- MINI TREK™ 1012270-12Abbott Vascular Inc. · Catheters, transluminal coronary angioplasty, percutaneous162 reports
- Maverick²™ H7493892820200Boston Scientific Corporation · Catheters, transluminal coronary angioplasty, percutaneous161 reports
- NC TREK 1012454-08Abbott Vascular Inc. · Catheters, transluminal coronary angioplasty, percutaneous2 recalls59 reports
- TREK™ 1012272-15Abbott Vascular Inc. · Catheters, transluminal coronary angioplasty, percutaneous2 deaths158 reports
- NC TREK 1012453-12Abbott Vascular Inc. · Catheters, transluminal coronary angioplasty, percutaneous1 recall84 reports
- NC TREK 1012453-15Abbott Vascular Inc. · Catheters, transluminal coronary angioplasty, percutaneous1 recall1 death83 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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