Beacon Care Package - Soft Tissue (17G) ASM0607-001Recalls & reported problems
Varian Medical Systems, Inc. · The Beacon transponder is an implantable wireless device composed of an internal circuit and encapsulation materials. The internal circuit resonates in response to an external AC magnetic field. The Beacon Care package consists of three Beacon transponders, each with a dedicated introducer needle. The Beacon transponders are implanted in or near the treatment target. The resonance signal is used to measure the location of the transponder, by the Calypso System. The BCP-Soft Tissue many only be used with the Calypso System v3.0 or higher. · 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 00850011006047), received between Sep 5, 2023 and Sep 5, 2023 — classified as 1 injury.
The most frequently reported specific device problem is “Device Handling Problem” (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
Device problems
- Device Handling Problem1
Patient problems
- Foreign Body In Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjurySep 5, 2023Device Handling Problem; Device Handling Problem
THE DOCTOR EXPLAINED THAT THE CALYPSO NEEDLE BROKE OFF IN THE PATIENT DURING A ROUTINE CALYPSO PROCEDURE. THERE IS APPROXIMATELY 2 CM THAT WAS UNABLE TO BE RETRIEVED FROM THE PATIENT. THE HOSPITAL INFORMED THAT THE PATIENT HAS HAD THE PIECE REMOVED SUCCESSFULLY. SO FAR THERE ARE NO COMPLICATIONS. THE AFFECTED DEVICE WAS SENT BY THE CUSTOMER FOR INVESTIGATION.
Patient problems: Foreign Body In Patient
MAUDE report 17686218 ↗
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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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