United States Surgical
FDA adverse event reports naming United States Surgical as the device manufacturer, with recall history from the live FDA recall database. Reporter-supplied name as filed: UNITED STATES SURGICAL.
- Total reports
- 2,391
- Deaths
- 28
- Injuries
- 1,724
- Malfunctions
- 609
Reports per year
Source: FDA adverse event reports by year received, 1999–2014. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.
Top device categories
- Staple, ImplantableGDW1,205
- Instrument, Ultrasonic SurgicalLFL207
- Laparoscope, General & Plastic SurgeryGCJ202
- Suture, Absorbable, Synthetic, Polyglycolic AcidGAM178
- Product code KOGKOG156
- Stapler, SurgicalGAG93
- Clip, ImplantableFZP88
- Electrosurgical, Cutting & Coagulation & AccessoriesGEI71
- Applier, Surgical, ClipGDO55
- Sealant, DuralNQR25
Recent recalls
- 2006-06-17TerminatedOther
Auto Suture-ChemoSite Low Profile -implantable low profile Venous Access System with printed polyurethane catheter and 9 French Introducer Kit Catalog Number: 120021
The 9F device may contain a 10 F sheath instead of the 9F
- 2006-06-17TerminatedOther
Auto Suture ChemoSite Low Profile Venous Access System with 9FR Introducer Kit with Silicone Catheter Catalog Number: 120025
The 9F device may contain a 10 F sheath instead of the 9F
- 2006-06-17TerminatedOther
Auto Suture ChemoSite Catheter 9FR Introducer Kit with 9FR Peel-Away Sheath Catalog Number: 120039
The 9F device may contain a 10 F sheath instead of the 9F
- 2006-06-17TerminatedOther
Auto Suture ChemoSite Implantablei Venous Kit Access System with 9FR Introducer Kit Catalog Number: 120045
The 9F device may contain a 10 F sheath instead of the 9F
- 2006-06-17TerminatedOther
Auto Suture ChemoSite Catheter Introducer Kit with 9FR Peel-Away Sheath Catalog Number: 120049
The 9F device may contain a 10 F sheath instead of the 9F
- 2006-06-17TerminatedOther
Auto Suture ChemoSite Implantable Venous Access System with 9FR Introducer Kit with Silicone Catheter Catalog Number: 120066
The 9F device may contain a 10 F sheath instead of the 9F
- 2005-08-06TerminatedOther
ChemoSite Low Profile, Implantable Low Profile Mini Catheter Venous Access System with printed Polyurethane Catheter and 7 French Introducer Kit Catalog Number: 120011
The peel away introducer sheath may have cracked hubs/handles and /or improper peeling of the sheath during use
- 2005-08-06TerminatedOther
ChemoSite Low Profile, Implantable Low Profile Mini Catheter Venous Access System with printed Polyurethane Catheter and 9 French Introducer Kit Catalog Number: 120021
The peel away introducer sheath may have cracked hubs/handles and /or improper peeling of the sheath during use
- 2005-08-06TerminatedOther
ChemoSite Low Profile, Implantable Low Profile Mini Catheter Venous Access System with 9 French Introducer Kit with Silicone Catheter Catalog Number: 120025
The tear away inroducer sheath may have cracked hubs/handles and /or improper peeling of the sheath during use
- 2005-08-06TerminatedOther
ChemoSite Catheter Introducer Kit with 9 French Peel-Away Sheath Catalog Number: 120039
The tear away introducer sheath may have cracked hubs/handles and /or improper peeling of the sheath during use
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