System, Suction, Lipoplasty
General, Plastic Surgery · 21 CFR 878.5040
See Federal Register Notice at 86 FR 50887 Consolidation of Devices That Process Autologous Human Cells, Tissues, and Cellular and Tissue-Based Products at the Point of Care to Produce a Therapeutic Article (FRN) (FDA-2021-N-0881).
Recent MDR events
363 adverse event reports on file
- PSI-TEC III ASPIRATOR, 110VFeb 25, 2026MalfunctionMentor Texas1645337-2026-02074
- HUNSTAD INFILTRATION HANDLEDec 22, 2025MalfunctionMentor Texas1645337-2025-14136
- HUNSTAD HANDLEDec 22, 2025MalfunctionMentor Texas1645337-2025-14137
- HUNSTAD INFILTRATION HANDLENov 20, 2025MalfunctionMentor Texas1645337-2025-12890
- PSI-TECIII ASPIRATOR 110V,STNDSep 25, 2025MalfunctionMentor Texas1645337-2025-10709
- PSI-TEC III ASPIRATOR, 110VAug 11, 2025MalfunctionMentor Texas1645337-2025-08805
- PSI-TECIII ASPIRATOR 110V,STNDMay 14, 2025MalfunctionMentor Texas1645337-2025-05262
- PSI-TEC III ASPIRATORApr 30, 2025MalfunctionByron Medical / Mentor Texas L.p.MW5169674
- HUNSTAD INFILTRATION HANDLEMar 18, 2025MalfunctionMentor Texas1645337-2025-02873
- HUNSTAD INFILTRATION HANDLEMar 18, 2025MalfunctionMentor Texas1645337-2025-02871
Event type breakdown
Product problems
Reported product problem codes, most common first
Trend for “Break”
Recalls
15 recall events for this product code
- Terumo BCT, Inc.TerminatedNov 30, 2016
Adiprep Adipose Transfer System. Product Codes: 51431; 51432; 51433; 514001-347.
Terumo BCT announces a voluntary field action for the Harvest : Adiprep Adipose Transfer System because the affected product is incorrectly labeled and has the potential for operator confusion.
Z-0674-2017 · View FDA record ↗ - Globalmed LogistixTerminatedJan 25, 2016
Lipogems SPA Aspiration Cannulae, intended for aspiration of adipose tissue. LGC 13G (13G x 185mm), Sterile.
The cannulae may bend during procedure.
Z-0690-2016 · View FDA record ↗ - MicroAire Surgical Instruments, LLCTerminatedSep 30, 2015
ASP-1020 LipoTower with Aspiration Pump. Medical use.
There is potential risk of electrical shock if lead wires inside the device become detached and the ground connection fails.
Z-2821-2015 · View FDA record ↗ - MicroAire Surgical Instruments, LLCTerminatedSep 30, 2015
ASP-1021 LipoTower with Aspiration Pump and Tumescent Pump.
There is potential risk of electrical shock if lead wires inside the device become detached and the ground connection fails.
Z-2822-2015 · View FDA record ↗ - Mentor Texas, IncTerminatedSep 20, 2007
5mm x 30cm Hollow "Golf" Tip Ultrasonic Aspiration Probe, Model 5620-530, Catalog Number 5620-530.
Mis-identified and mis-labeled surgical probes were distributed. 5mm x 30cm Hollow "Golf" Tip Ultrasonic Aspiration Probe, Model 5620-530, Catalog Number 5620-530 was shipped, instead of LySonix 5mm x 30cm Hollow Bullet Tip Ultrasonic Probe, Catalog Number 5610-530.
Z-1230-2007 · View FDA record ↗ - Shippert Medical TechnologiesTerminatedUnknown
Tissu-Trans Filtron 1000 Catalog Number 3-TT-FILTRON 1000.
Potential breach of sterility of the packaging.
Z-0170-2018 · View FDA record ↗ - LifeCell Corporation, A Wholly Owned Subsidiary of Allergan PLCTerminatedUnknown
REVOLVE ADVANCED ADIPOSE SYSTEM, for aspiration, harvesting, filtering, and transferring of autologous adipose tissue for aesthetic body contouring.
Presence of bacterial endotoxins levels above the acceptable limit
Z-0823-2018 · View FDA record ↗ - Shippert Medical TechnologiesCompletedUnknown
Tissu-Trans FILTRON 100, Catalog 3-TT-FILTRON 100, sterile, disposable, one-patient use. The firm name on the label is Shippert Medical Technologies, Centennia
The pouch integrity of the sterile product can't be assured without a visual examination due to possibly containing a cut or hole in the pouch.
Z-1330-2019 · View FDA record ↗ - Shippert Medical TechnologiesCompletedUnknown
Tissu-Trans FILTRON 250, Catalog 3-TT-FILTRON 250, sterile, disposable, one-patient use. The firm name on the label is Shippert Medical Technologies, Centennia
The pouch integrity of the sterile product can't be assured without a visual examination due to possibly containing a cut or hole in the pouch.
Z-1331-2019 · View FDA record ↗ - Shippert Medical TechnologiesCompletedUnknown
Tissu-Trans FILTRON 500, Catalog 3-TT-FILTRON 500, sterile, disposable, one-patient use. The firm name on the label is Shippert Medical Technologies, Centennia
The pouch integrity of the sterile product can't be assured without a visual examination due to possibly containing a cut or hole in the pouch.
Z-1332-2019 · View FDA record ↗
Registered firms
56 firms currently registered for this product code
Isomedix Operations, Inc.
Temecula, CA, US
Trident Manufacturing, Inc.
Pingree Grove, IL, US
Lipogems International S.p.a.
Milan Milano, IT
Solta Medical, Inc.
Bothell, WA, US
Sterigenics Us Llc
Fort Worth, TX, US
Syntr Health Technologies, Inc.
Irvine, CA, US
Sterigenics Us Llc
Gurnee, IL, US
Sterigenics Radiation Technologies, Llc
San Diego, CA, US
Medikan Co., Ltd.
Gangseo-gu Seoul, KR
Abbvie Ireland Nl B.v. Ballytivnan
Sligo, IE
Ranfac Corp.
Avon, MA, US
Primo Medical Group, Inc
W Bridgewater, MA, US
Microaire Surgical Instruments Llc
CHARLOTTESVILLE, VA, US
Sterigenics Us Llc
Charlotte, NC, US
Millennium Medical Technologies Inc./dba Cellmyx
Carlsbad, CA, US
Sterigenics U.s., Llc
Rockaway, NJ, US
Isomedix Operations Inc.
Northborough, MA, US
The Metrix Company
DUBUQUE, IA, US
Cell Surgical Network Corporation
Rancho Mirage, CA, US
Wicki Medical, Llc
Pittsburgh, PA, US
Summit Medical Llc
Saint Paul, MN, US
510(k) clearances
40 clearances for this product code
- Millennium Medical Technologies Inc (Dba Cellmyx)Mar 16, 2022
K210528 · IntelliFat Disposable Adipose Tissue Harvesting and Transfer Kit, IntelliFat Body On Demand (BOD) Kit
- Syntr Health Technologies, Inc.Jul 2, 2021
K203800 · SyntrFuge System
- Bsl Co., Ltd.Mar 11, 2021
K202443 · Smart Kit Basic, Smart Kit Pro
- Lifecell CorporationMay 28, 2020
K193539 · REVOLVE ENVI 600 Advanced Adipose System
- Puregraft, LLCApr 14, 2020
K193363 · Dermapose Refresh
- Jointechlabs, Inc.Nov 18, 2019
K182732 · JTL-250-01
- Emcyte CorporationNov 7, 2019
K191564 · Progenikine Concentrating System 25 mL System
- Stemics S.A.SOct 10, 2019
K190386 · KTA Adipose Treatment Kit