Kinetic Concepts, Inc.
FDA adverse event reports naming Kinetic Concepts, Inc. as the device manufacturer, with recall history from the live FDA recall database. Reporter-supplied name as filed: KINETIC CONCEPTS, INC..
- Total reports
- 2,309
- Deaths
- 57
- Injuries
- 989
- Malfunctions
- 1,224
Reports per year
Source: FDA adverse event reports by year received, 2006–2024. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.
Top device categories
- Negative Pressure Wound Therapy Powered Suction PumpOMP2,112
- Apparatus, Suction, Ward Use, Portable, Ac-PoweredJCX100
- Bed, Air FluidizedINX30
- Mattress, Flotation Therapy, Non-PoweredIKY16
- Bed, Flotation Therapy, PoweredIOQ12
- Bed, Ac-Powered Adjustable HospitalFNL9
- Mattress, Air Flotation, Alternating PressureFNM8
- Bed, Patient Rotation, PoweredIKZ7
- Negative Pressure Wound Therapy Non-Powered Suction ApparatusOKO4
- Bed, ManualFNJ3
Recent recalls
- 2006-05-23TerminatedOther
Sterile packaged wound dressing with white and green inner pouch and outer carton labels, labeled in part:''***V.A.C.*** ABDOMINAL DRESSING WITH NON ADHERENT LAYER***Re-Order No. M6275080/5***Manufactured for Corporate Headquarters: KCI USA, Inc., 8023 Vantage Dr., San Antonio, TX 78230 USA***''.
Complaints received regarding difficulty opening the nonadherent layer of the device prior to application to open abdominal wounds.
- 2006-02-14TerminatedOther
RotoProne powered patient rotation bed, part #209500, distributed by Kinetic Concepts, Inc., San Antonio, TX.
To correct software issues in software versions 1.3 and 1.5 and to upgrade hatch latch handles to a more ergonomic design.
- 2006-01-11TerminatedOther
V.A.C. ATS Canister with Gel (500 mL), Part #M6275063/10.S, distributed by Kinetic Concepts, Inc., San Antonio, TX. Product is labeled as STERILE.
Possible mislabeling of shipping cartons.
- 2005-11-08TerminatedOther
Bari Maxx II, KCI''s BariMaxx II bariatric bed, P/N 310611, November 2001, KCI The Clinical Advantage, P. O. Box 659508, San Antonio, Texas 78265-9508, Call Toll Free 1-800-531-5346, FAX (210) 308-3998, Http://www.kci1.com
Design change to uppgrade reliability of powered adjustable bed.
- 2005-03-10TerminatedOther
KinAir MedSurg, flotation therapy, powered hospital bed, manufactured by Kinetic Concepts, Inc., San Antonio, Texas
Weld failure causes side rail welds to turn upside down or break off of the bed.
- 2004-10-22TerminatedOther
V.A.C. X-Large Granufoam Dressing Part Numbers M6275065/5, V.A.C. ATS and V.A.C. Freedom and M6275043/5 V.A.C. Classic. Manufactured by Kinetic Concepts, Inc., San Antonio, Texas 78230
The seal on the dressing pouch may open during shipping and sterility of the dressing may be compromised.
- 2004-07-20TerminatedOther
KCI TriaDyne Proventa Critial Care Therapy System, manufactured by Kinetic Concepts, Inc., San Antonio, Texas 78219. Model number 308900
Battery outgassing of powered hospital beds
- 2004-07-20TerminatedOther
KCI Therapulse II Air Suspension Therapy Bed, manufactured by Kinetic Concepts, Inc., San Antonio, TX 78219. Model number 227080
Battery outgassing of powered hospital beds
- 2004-07-20TerminatedOther
Burke Bariatric Bed, manufactured by Kinetic Concepts, Inc., San Antonio, TX, model number 7064
Battery outgassing of powered hospital beds
- 2004-07-20TerminatedOther
KCI Underbed Inverter, Accessory to Powered Flotation Therapy Bed, manufactured by Kinetic Concepts, Inc., San Antonio, TX. Model number 201189
Battery outgassing of powered hospital beds
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