Zoom 88 Large Distal Platform Support ICTC088100SRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00812212030573), received between Jul 29, 2026 and Jul 29, 2026 — classified as 1 injury.

The most frequently reported specific device problem is “Break” (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

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryJul 29, 2026Break; Material Separation

  It was reported that during a carotid stent procedure, a Zoom 88 Support catheter became kinked approximately 14 cm from the distal tip while positioned in the iliac artery. During the first pass, resistance was encountered during advancement at which time the kink at 14cm was observed. Resistance was also encountered during retraction while attempting to exchange the catheter for a new Zoom 88 Support. As the physician attempted to withdraw the catheter, it fractured approximately 14 cm from the distal tip. A goose neck snare was used in an attempt to retrieve the detached catheter segment; however, retrieval was unsuccessful, and the fragment remained in the common iliac artery without limiting blood flow. Open surgical intervention was subsequently performed to access the iliac artery and retrieve the distal catheter fragment. The catheter segment was successfully retrieved, and the patient was reported to be alive following the procedure.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50064306 ↗