MKNClass 3
Catheter, Balloon, Transcervical
FDA adverse event reports and recall history for catheter, balloon, transcervical (product code MKN), from the public MAUDE/AEMS corpus and the live FDA recall database.
- Total reports
- 753
- Deaths
- 8
- Injuries
- 298
- Malfunctions
- 418
Reports per year
13302
2403
4004
3605
5906
9607
8408
7809
8210
2411
812
913
714
515
116
Source: FDA adverse event reports by year received, 2002–2016. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.
Recent recalls
No recalls listed in the FDA device recall database for this entry.
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