Concerto Versa™ CV-5-30 (UDI 00763000936648)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00763000936648), received between Sep 11, 2026 and Sep 17, 2026 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (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 16, 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.

• MalfunctionSep 17, 2026Entrapment of Device; Premature Separation

  It was reported that during coil packing at the intended site for treatment of a right external femoral and profunda arteriovenous m alformation, a CV-5-30 Versa coil prematurely detached from the pusher wire. Two CV-6-20 coils were delivered without issue before the reported event. The artery measured 4mm, had minimal tortuosity, and abnormal vascular anatomy was reported. A 65cm 4Fr non-Medtronic (Terumo Glidecath) diagnostic catheter, a Medtronic instant detacher, and a 45cm 6Fr non-Medtronic (Terumo) sheath were used. The device was prepared according to the instructions for use, and a continuous heparinized saline flush was administered. The pusher delivery system was advanced more than 2 cm distally beyond the diagnostic catheter. The physician repositioned the coil and rotated the delivery pusher. The physician attempted to use the pusher wire to deliver the prematurely detached coil. The pusher wire got on other side of CV-5-30 coil and got stuck in the coil pack of the previously deployed CV-6-20 coils. After multiple different attempts to free the pusher wire were unsuccessful, the whole coil pack was removed from the patient and the case was started over. The issue was r

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50802465 ↗
• MalfunctionSep 11, 2026Detachment of Device or Device Component; Positioning Problem

  It was reported that a CONCERTO VERSA COIL was used during coil embolization of a right iliac artery pseudoaneurysm from trauma, and moderate vessel tortuosity was noted. A 2.8 non-Medtronic (Prograte) microcatheter, a 6Fr sheath, and a non-Medtronic (Boston Sci Fathom) guidewire were used. The device was prepared as indicated in the IFU without issue. During the procedure, difficult placement was reported. The Physician was advancing the coil quickly and the non-Medtronic microcatheter kicked back out of the tight neck of the aneurysm. Physician attempted to re-engage over the coil but was unsuccessful so removed coil. Physician attempted to re-engage the neck with non-Medtronic guidewire and was unsuccessful. Physician took another shot and aneurysm was shut down so called case. The coil did not meet Physician expectations. The coil was not implanted. The event was reported as resolved. No vessel damage reported. No patient complications have been reported as a result of this event. While advancing the coil the 2.8 non-Medtronic (Prograte) microcatheter was kicked out of the neck of the aneurysm causing the Physician to lose access to the aneurysm and he was not able to regain ac

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50727049 ↗