ViewFlex™ Eco D087031-RRecalls & reported problems
St. Jude Medical, Inc. · Reprocessed ICE Catheter · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 05415067041630), received between Jun 27, 2024 and Feb 20, 2025 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Fracture” (3 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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Fracture3
Patient problems
- No Clinical Signs, Symptoms or Conditions3
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 20, 2025Fracture; Fracture
DURING THE PVC ABLATION, THE VIEWFLEX CATHETER FRACTURED. THE CATHETER WAS PLACED IN THE LEFT FEMORAL VEIN VIA A NON-ABBOTT SHEATH (COOK BRAND 10F SHEATH). WHEN INSERTED INTO THE SHEATH, THE CATHETER FRACTURED. THE DEVICE WAS REPLACED AND THERE WERE NO ADVERSE PATIENT CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21424318 ↗MalfunctionOct 12, 2024Fracture; Fracture
DURING THE ATRIAL FIBRILLATION PROCEDURE, IT WAS NOTED THAT THE DISTAL END OF THE CATHETER FRACTURED UPON INSERTION INTO THE LEFT FEMORAL VEIN VIA A 10F LONG SHEATH. THE CATHETER WAS REPLACED, AND THE PROCEDURE WAS COMPLETED WITH NO ADVERSE CONSEQUENCES TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20435057 ↗MalfunctionJun 27, 2024Fracture; Fracture
THIS REPORT IS TO ADVISE OF A FRACTURE THAT WAS NOTED DURING ANALYSIS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19623242 ↗
Other Reprocessed intravascular ultrasound catheter devices
- MEDLINE D087031RHMedline Industries, Inc. · Reprocessed intravascular ultrasound catheter2 recalls5 reports
- MEDLINE 10135936RHMedline Industries, Inc. · Reprocessed intravascular ultrasound catheter2 recalls0 reports
- MEDLINE 10135910RHMedline Industries, Inc. · Reprocessed intravascular ultrasound catheter2 recalls0 reports
- NA ACU10135936Sterilmed, Inc. · Reprocessed intravascular ultrasound catheter1 recall11 reports
- NA ACU10135910Sterilmed, Inc. · Reprocessed intravascular ultrasound catheter1 recall6 reports
- MEDLINE 10438577RHMedline Industries, Inc. · Reprocessed intravascular ultrasound catheter1 recall0 reports
- MEDLINE 10439072RHMedline Industries, Inc. · Reprocessed intravascular ultrasound catheter1 recall0 reports
- MEDLINE 10439011RHMedline Industries, Inc. · Reprocessed intravascular ultrasound catheter1 recall0 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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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