Sure-Point™ D0136200Recalls & reported problems
C. R. Bard, Inc. · Sure-Point™ Tracker · Class 2
Data updated Oct 13, 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 00801741078897), received between Oct 2, 2019 and Oct 2, 2019 — classified as 1 injury.
The most frequently reported specific device problem is “No Display/Image” (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.
Most reported problems
Device problems
- No Display/Image1
Patient problems
- No Code Available1
- 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.
InjuryOct 2, 2019No Display/Image
IT WAS REPORTED THAT THE TRACKER CONTROL BOX'S LINEAR ENCODER WAS NOT WORKING. WHEN ADVANCING, THE DEVICE WOULD NOT SHOW IMAGES. PER ADDITIONAL INFORMATION RECEIVED ON 12SEP2019, A MALE PATIENT WAS UNDERGOING A RECTAL ULTRASOUND GUIDED PROBE FOR PREPLANNING OF BRACHYTHERAPY SEED MAPPING AND PLACEMENT. THE DEVICE WOULD NOT DISPLAY IMAGES OF THE PROSTATE GLAND. THE PHYSICIAN HAD TO COLLECT MANUAL IMAGES AND THIS EXTENDED THE PATIENT'S PROCEDURE UNDER CONSCIOUS SEDATION. THE PATIENT DID NOT INCUR ANY INJURY DUE TO THE EXTENDED PROCEDURE TIME AND CONSCIOUS SEDATION TIME. THE DEVICE WAS SENT TO THE BIOMED FOR EVALUATION.
Patient problems: No Code Available; Patient Problem/Medical Problem
MAUDE report 9146390 ↗
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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 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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