StoneBreaker G52605Recalls & reported problems
Cook Incorporated · StoneBreaker Single Use Probe 1.0mm/605mm · Class 2
Data updated Oct 18, 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 00827002526051), received between Mar 28, 2018 and Mar 28, 2018 — classified as 1 malfunction.
The most frequently reported specific device problem is “Device Contamination with Chemical or Other Material” (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 Contamination with Chemical or Other Material1
- Packaging Problem1
Patient problems
- No Patient Involvement1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 28, 2018Device Contamination with Chemical or Other Material; Packaging Problem; Device Contamination with Chemical or Other Material; Packaging Problem
IT WAS REPORTED WHEN GATHERING PRODUCTS FOR A RECALL RESPONSE, A HAIR WAS OBSERVED IN THE STERILE PACKAGE OF THIS STONEBREAKER SINGLE USE PROBE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT AS A RESULT OF THIS REPORTED ISSUE. THE DEVICE DID NOT MAKE CONTACT WITH THE PATIENT.
Patient problems: No Patient Involvement
MAUDE report 7377182 ↗
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- Ultrasound Probe M0068407160Boston Scientific Corporation · Lithotriptor, electro-hydraulic3 reports
- CyberWand USL Advanced Transducer CW-USLTACybersonics Inc · Lithotriptor, Electro-Hydraulic2 reports
- CyberWand USL NoseCone Kit CW-USLNCCybersonics Inc · Lithotriptor, Electro-Hydraulic1 report
- CyberWand USL Advanced Transducer CW-USLTACybersonics Inc · Lithotriptor, Electro-Hydraulic1 report
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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