Malecot G16922Recalls & reported problems
Cook Incorporated · Silicone Malecot Catheter · Class 2
Data updated Oct 16, 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 00827002169227), received between Jul 14, 2016 and Jul 14, 2016 — classified as 1 malfunction.
The most frequently reported specific device problem is “Break” (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 16, 2026.
Most reported problems
Device problems
- Break1
Patient problems
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 14, 2016Break; Break
IT WAS REPORTED THAT DURING A ID IND RECTAL ABSCESS PROCEDURE, WHEN REMOVING THE CATHETER, THE DEVICE SNAPPED IN HALF AND THE TIP OF THE DEVICE BROKE OFF. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT'S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES NOR EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 5793483 ↗
Other CATHETER, SUPRAPUBIC (AND ACCESSORIES) devices
- Rutner G14920Cook Incorporated · CATHETER, SUPRAPUBIC (AND ACCESSORIES)5 reports
- Rutner G15261Cook Incorporated · CATHETER, SUPRAPUBIC (AND ACCESSORIES)4 reports
- Cook G26666Cook Incorporated · CATHETER, SUPRAPUBIC (AND ACCESSORIES)4 reports
- Malecot G16923Cook Incorporated · CATHETER, SUPRAPUBIC (AND ACCESSORIES)1 report
- Cook G14899Cook Incorporated · CATHETER, SUPRAPUBIC (AND ACCESSORIES)1 report
- Ultrathane G30401Cook Incorporated · CATHETER, SUPRAPUBIC (AND ACCESSORIES)1 report
- Cook G14095Cook Incorporated · CATHETER, SUPRAPUBIC (AND ACCESSORIES)1 report
- Cook G26655Cook Incorporated · CATHETER, SUPRAPUBIC (AND ACCESSORIES)1 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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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