Amplatz G14292Recalls & reported problems
Cook Incorporated · Amplatz Renal Dilator Set · Class 2
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 00827002142923), received between Aug 18, 2017 and Aug 18, 2017 — 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. How this data works · Data updated Oct 13, 2026.
Most reported problems
Device problems
- Device Contamination with Chemical or Other Material1
Patient problems
- No Consequences Or Impact To Patient1
- 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.
MalfunctionAug 18, 2017Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
IT WAS REPORTED THAT PRIOR TO PERFORMING A PROCEDURE, THE OPERATOR OBSERVED A HAIR-LIKE FIBER INSIDE OF THE SEALED PACKAGE CONTAINING AN AMPLATZ RENAL DILATOR SET. THIS ISSUE WAS DISCOVERED PRIOR TO USE AND THE DEVICE WAS NOT USED. THE DEVICE DID NOT COME IN CONTACT WITH A PATIENT. NOT USED ON PATIENT; NO PATIENT INVOLVEMENT AND NO PATIENT IMPACT.
Patient problems: No Consequences Or Impact To Patient; No Patient Involvement
MAUDE report 6803144 ↗
Other DILATOR, URETHRAL devices
- Bard® Urologist's Tray 123400C. R. Bard, Inc. · DILATOR, URETHRAL1 recall8 reports
- UroMax Ultra Kit M0062251210Boston Scientific Corporation · DILATOR, URETHRAL1 recall6 reports
- UroMax Ultra Kit M0062251220Boston Scientific Corporation · DILATOR, URETHRAL1 recall5 reports
- UroMax Ultra Kit M0062251370Boston Scientific Corporation · DILATOR, URETHRAL1 recall4 reports
- UroMax Ultra Kit M0062251200Boston Scientific Corporation · DILATOR, URETHRAL1 recall3 reports
- UroMax Ultra Kit M0062251310Boston Scientific Corporation · DILATOR, URETHRAL1 recall2 reports
- UroMax Ultra Kit M0062251290Boston Scientific Corporation · DILATOR, URETHRAL1 recall2 reports
- UroMax Ultra Kit M0062251240Boston Scientific Corporation · DILATOR, URETHRAL1 recall1 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 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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