Catheter, Suprapubic (And Accessories)
FDA adverse event reports and recall history for catheter, suprapubic (and accessories) (product code KOB), from the public MAUDE/AEMS corpus and the live FDA recall database.
- Total reports
- 204
- Deaths
- 1
- Injuries
- 116
- Malfunctions
- 82
Reports per year
Source: FDA adverse event reports by year received, 2012–2026. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.
Recent recalls
- 2005-09-02TerminatedOther
Banana Peel Sheaths BP/9/15 Catalog Number: 20-606
The Tearaway Introducer Sheath may have cracked hubs/handles and/or improper peeling during use.
- 2005-09-02TerminatedOther
Banana Peel Sheaths BP/11/15 Catalog Number: 20-607
The Tearaway Introducer Sheath may have cracked hubs/handles and/or improper peeling during use.
- 2005-09-02TerminatedOther
Banana Peel Sheaths BP/12/15 Catalog Number: 20-608
The Tearaway Introducer Sheath may have cracked hubs/handles and/or improper peeling during use.
- 2005-09-02TerminatedOther
Banana Peel Sheaths BP/14/15 Catalog Number: 20-609
The Tearaway Introducer Sheath may have cracked hubs/handles and/or improper peeling during use.
- 2005-09-02TerminatedOther
Banana Peel Sheaths BP/16/15 Catalog NUmber : 20-610
The Tearaway Introducer Sheath may have cracked hubs/handles and/or improper peeling during use.
- 2005-09-02TerminatedOther
Banana Peel Sheaths BP/9/30 Catalog Number : 20-612
The Tearaway Introducer Sheath may have cracked hubs/handles and/or improper peeling during use.
- 2005-09-02TerminatedOther
Banana Peel Sheaths BP/11/30 Catalog Number : 20-613
The Tearaway Introducer Sheath may have cracked hubs/handles and/or improper peeling during use.
- 2005-09-02TerminatedOther
Banana Peel Sheaths BP/12/30 Catalog Number : 20-614
The Tearaway Introducer Sheath may have cracked hubs/handles and/or improper peeling during use.
- 2005-09-02TerminatedOther
Banana Peel Sheaths BP/14/30 Catalog Number : 20-615
The Tearaway Introducer Sheath may have cracked hubs/handles and/or improper peeling during use.
- 2005-09-02TerminatedOther
Banana Peel Sheaths BP/16/30 Catalog Number : 20-616
The Tearaway Introducer Sheath may have cracked hubs/handles and/or improper peeling during use.
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