ASSURANT® COBALT ASC930LVRecalls & reported problems
Medtronic, Inc. · Stent ASC930LV AssrntCo 9mmx30mmx130cm · Class 3
Data updated Oct 16, 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 00613994931122), received between Apr 27, 2017 and Apr 27, 2017 — 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 16, 2026.
Most reported problems
Device problems
- Burst Container or Vessel1
- Detachment of Device or Device Component1
Patient problems
- Patient Problem/Medical Problem1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryApr 27, 2017Burst Container or Vessel; Detachment of Device or Device Component; Burst Container or Vessel; Detachment of Device or Device Component
IT WAS REPORTED VIA MEDWATCH THAT A PHYSICIAN WAS ATTEMPTING TO USE AN ASSURANT COBALT STENT TO TREAT A CALCIFIED LEFT SFA. DURING PTA, CALCIFICATION WAS REPORTED TO HAVE CAUSED THE STENT DELIVERY SYSTEM BALLOON TO FRACTURE. THE PATIENT WAS TRANSFERRED TO ANOTHER HOSPITAL TO HAVE THE ITEM REMOVED AND A NEW STENT WAS PLACED. NO PATIENT INJURY REPORTED.
Patient problems: Patient Problem/Medical Problem
MAUDE report 6525229 ↗
Other STENT, ILIAC devices
- Cordis S.M.A.R.T. Control Vascular Stent System C10040MLCordis US Corp. · STENT, ILIAC1 recall3 reports
- Absolute Pro 1012534-100Abbott Vascular Inc. · STENT, ILIAC51 reports
- Cordis S.M.A.R.T. Control Vascular Stent System C09060MLCordis US Corp. · STENT, ILIAC1 recall0 reports
- Protégé™ GPS™ SERB65-09-60-80Ev3, Inc · STENT, ILIAC1 recall0 reports
- Absolute Pro 1012535-100Abbott Vascular Inc. · STENT, ILIAC1 death41 reports
- Omnilink Elite 1012631-39Abbott Vascular Inc. · STENT, ILIAC27 reports
- Omnilink Elite 1012632-29Abbott Vascular Inc. · STENT, ILIAC25 reports
- Omnilink Elite 1012631-59Abbott Vascular Inc. · STENT, ILIAC21 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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