Astron 10/60/72Recalls & reported problems
Biotronik AG · Class 3 · Implant
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07640130412330), received between Nov 11, 2024 and Nov 11, 2024 — classified as 1 malfunction.
The most frequently reported specific device problem is “Malposition of Device” (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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Malposition of Device1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 11, 2024Malposition of Device; Malposition of Device
THE PHYSICIAN INTENDED TO TREAT A TOTAL OCCLUSION IN THE LEFT SUBCLAVIAN ARTERY. AN OLD STENT (UNKNOWN MANUFACTURER) WAS PRESENT IN THE OCCLUDED VESSEL. AFTER CROSSING THE LESION WITH A 0.035 INCH TERUMO 180 CM GLIDEWIRE AND PRE-DILATION WITH A 9 MM BALLOON CATHETER, THE COMPLAINT DEVICE WAS INSERTED INTO THE PATIENT USING A SHORT 6F MERIT MEDICAL PRELUDE INTRODUCER SHEATH. ACCORDING TO THE PHYSICIANS DESCRIPTION, THE LESION WAS REACHED WITH NO REPORTED ISSUES. ONCE THE DEVICE WAS POSITIONED IN THE TARGET LESION, IT BECAME APPARENT THAT THERE WAS NO STENT IN THE CATHETER. THE COMPLAINT DEVICE WAS WITHDRAWN AND A SECOND ASTRON 10/60/72 WAS USED TO SUCCESSFULLY FINALIZE THE INTERVENTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20658626 ↗
Other STENT, ILIAC devices
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- Protégé™ GPS™ SERB65-09-60-80Ev3, Inc · STENT, ILIAC1 recall0 reports
- Cordis S.M.A.R.T. Control Vascular Stent System C09060MLCordis US Corp. · 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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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