Agent, Bulking, Injectable For Gastro-Urology Use
FDA adverse event reports and recall history for agent, bulking, injectable for gastro-urology use (product code LNM), from the public MAUDE/AEMS corpus and the live FDA recall database.
- Total reports
- 1,153
- Deaths
- 8
- Injuries
- 750
- Malfunctions
- 161
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
- 2005-10-28TerminatedOther
Enteryx Procedure Kit Order No.: M00572600 -US and M00572500 -OUS
Incorrect implantation may cause serious health complications
- Open, ClassifiedLabeling design
COAPTITE Injectable Implant, injectable, sterile, non-pyrogenic implant composed of spherical particles (75-125 microns in diameter of calcium hydroxylapatite (CaHA), suspended in aqueous based gel carrier. Gel carrier is composed of sodium carboxymethylcellulose, sterile water for injection, and glycerin. Product is packaged in a 1.0cc syringe and packed in a sterile pouch.
The Instructions for Use (IFU) updated 03/02/2020 does not match data listed in the post-approval study.
- TerminatedMaterial/Component Contamination
BULKAMID, URETHRAL BULKING SYSTEM model # 50050 containing the component: Bulkamid Needle, REF 230651221C, 2 G x 12 am, sterile, CE 0476
Lack of Sterility Assurance; needle in procedure pack labeled as sterile may not have been adequately sterilized
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