Symphony™ 16F 82cm Catheter SYMPHONY16F 82Recalls & reported problems
Imperative Care, Inc. · 16F 82cm Symphony™ Catheter w/ Dilator · 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 00850032079211), received between Nov 26, 2025 and Nov 26, 2025 — classified as 1 injury.
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.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Vascular Dissection1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryNov 26, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT DURING A THROMBECTOMY PROCEDURE, ACCESS WAS OBTAINED VIA A THIRD-PARTY MICROPUNCTURE DEVICE, 16F SHEATH AND GUIDEWIRE IN THE LEFT POPLITEAL VEIN. THE WIRE WAS ADVANCED WITH ASSISTANCE OF A THIRD-PARTY DIAGNOSTIC CATHETER, FOLLOWED BY USE OF SYMPHONY 16F 82CM CATHETER OVER THE GUIDEWIRE. THE SYMPHONY 16F 82CM CATHETER SUCCESSFULLY CROSSED FROM THE ILIAC TO THE INFERIOR VENA CAVA (IVC) AND ASPIRATION WAS PERFORMED SUCCESSFULLY. A RESIDUAL VENOGRAM REVEALED CALCIFICATION. THE PHYSICIAN DEPLOYED A THIRD-PARTY BALLOON AND SUBSEQUENT VENOGRAM REVEALED A NON-FLOW LIMITING DISSECTION IN THE FEMORAL VEIN. INTRAVASCULAR ULTRASOUND (IVUS) WAS THEN UTILIZED FOR MEASUREMENTS AND IDENTIFYING RESIDUAL CLOTS. A SECOND PASS WAS THEN PERFORMED WITH SYMPHONY 16F 82CM CATHETER BEFORE PLACEMENT OF STENT AND POST-DILATION. VENOGRAPHY SHOWED TWO RESIDUAL CHRONIC PLAQUES, AND A THIRD PASS WITH SYMPHONY 16F 82CM CATHETER CLEARED THE CHRONIC CLOT FROM THE COMMON FEMORAL VEIN. THE CAUSE OF THE DISSECTION IS UNKNOWN AND COULD BE ASSOCIATED WITH THE THIRD-PARTY WIRE, SYMPHONY 16F 82CM CATHETER, OR THIRD-PARTY BALLOON. PER THE PHYSICIAN, LIKELY THE BALLOON ANGIOPLASTY LED TO THE DISSECTION.
Patient problems: Vascular Dissection
MAUDE report 23662071 ↗
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- Indigo System LITNG12HTORQ100-APenumbra, Inc. · Peripheral Mechanical Thrombectomy With Aspiration1 death46 reports
- Triever 24 22-101Inari Medical, Inc. · Peripheral Mechanical Thrombectomy With Aspiration20 deaths34 reports
- ClotTriever Catheter, 16 mm 40-102Inari Medical, Inc. · Peripheral Mechanical Thrombectomy With Aspiration11 deaths27 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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