Device, Percutaneous, Biopsy
General, Plastic Surgery · 21 CFR 878.4800
Recent MDR events
44 adverse event reports on file
- KYPHON® EXPRESS¿ BONE BIOPSY DEVICEJun 5, 2025InjuryMedtronic Mexico S. De R.l. De Cv1030489-2025-02139
- DELTACUT BIOPSIE KANÜLEJul 9, 2024MalfunctionPajunk Gmbh Medizintechnologie9611612-2024-00006
- ACCESS KIT 10 GAUGE-DIAMOND TIP/END-OPENING-STERILEMar 15, 2024MalfunctionSynthes Gmbh8030965-2024-03704
- ACCESS KIT 10 GAUGE-DIAMOND TIP/END-OPENING-STERILEMar 15, 2024MalfunctionSynthes Gmbh8030965-2024-03705
- ACCESS KIT 10 GAUGE-DIAMOND TIP/END-OPENING-STERILEMar 15, 2024MalfunctionSynthes Gmbh8030965-2024-03703
- UNK - ACCESS KITSMar 14, 2024MalfunctionSynthes Gmbh8030965-2024-03655
- CHIBA BIOPSY NEEDLEJun 23, 2023MalfunctionCook Inc1820334-2023-00809
- ACCES KIT 10 GA-DIAMOND TIP/END-OPEN-STNov 29, 2021MalfunctionWrights Lane Synthes Usa Products Llc2939274-2021-06840
- 13 GA TAPERED CANNULA, TROCAR STYLET, BEVEL STYLETNov 3, 2021MalfunctionMedtronic Mexico9612164-2021-04192
- CHIBA BIOPSY NEEDLESep 17, 2021InjuryCook Inc1820334-2021-02165
Event type breakdown
Recalls
4 recall events for this product code
- MEDLINE INDUSTRIES, LP - NorthfieldOpen, ClassifiedSep 6, 2024
Medline Convenience kits, labeled as:
Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.
Z-3058-2024 · View FDA record ↗ - Cook IncorporatedOpen, ClassifiedApr 12, 2024
Chiba Biopsy Needle - Used for aspiration biopsy.
Packaging may have low seal strength and not meet peel strength specifications, compromising device sterility
Z-1525-2024 · View FDA record ↗ - Medical Device Technologies, Inc.TerminatedOct 8, 2010
Tru-Core II Disposable Automatic Biopsy Instrument and Tru-Core II URO Disposable Automatic Biopsy Instrument. The Tru-Core Disposable Automatic Biopsy Instrum
Medical Device Technologies, Inc., dba Angiotech, Gaineville, Florida is recalling Tru-Core II Disposable Biopsy Devices due to compromised packaging integrity. The Tru-Core Disposable Automatic Biopsy Instrument is used to obtain multiple core samples from soft tissue such as liver, kidney, prostate, breast, ect. The recall is for the following Model Numbers: 763114100X, 763114160X, 763114
Z-0025-2011 · View FDA record ↗ - M.D.L. S.r.l.TerminatedUnknown
General Manual surgical instrument
Sterility assurance may be compromised.
Z-2493-2021 · View FDA record ↗
Registered firms
70 firms currently registered for this product code
Isomedix Operations Inc
EL PASO, TX, US
Shoney Scientific, Inc.
WAUKESHA, WI, US
Argon Medical Devices, Inc.
WHEELING, IL, US
Pajunk Gmbh Medizintechnologie
GEISINGEN Baden-Wurttemberg, DE
Sterigenics U.s., Llc
Salt Lake City, UT, US
Sterigenics Us Llc
Grand Prairie, TX, US
Top Clean Injection
PESCHADOIRES Puy-de-Dome, FR
Medline Industries, Lp - Laredo
LAREDO, TX, US
Synthes Gmbh
Selzach Solothurn, CH
Biopsybell S.r.l.
MIRANDOLA Modena, IT
Promotec-medizintechnik Gmbh
Blankenfelde / Mahlow Brandenburg, DE
Sterigenics Us Llc
Gurnee, IL, US
Seawon Meditech Co., Ltd.
Bucheon-si Gyeonggi, KR
Midwest Sterilization Corp.
JACKSON, MO, US
Synthes (usa) Products Llc
West Chester, PA, US
Allwin Medical Devices Pvt. Ltd.
Surat Gujarat, IN
Cochlear Americas Warehouse
Centennial, CO, US
Biotronix Healthcare Industries Inc.
Orlando, FL, US
Depuy Spine, Inc.
RAYNHAM, MA, US
Jabil Inc. (monument)
Monument, CO, US
Cook Incorporated
Spencer, IN, US
Medtronic Sofamor Danek Usa, Inc.
Memphis, TN, US
Isomedix Operations Inc
El Paso, TX, US
Cook Incorporated
Bloomington, IN, US
Surgicon Pvt Ltd
Sialkot Punjab, PK
510(k) clearances
7 clearances for this product code
- PAJUNK GmbH MedizintechnologieMay 9, 2008
K080674 · PAJUNK'S PRIMOCUT DISPOSABLE BIOPSY SYSTEM
- Clevex, Inc.Apr 20, 2007
K070836 · EXICLIP EXCS-M
- Sts BiopolymersJan 20, 1999
K983647 · ECHO-COAT ULTRASOUND NEEDLES
- Contour Fabricators of Florida, Inc.Feb 1, 1996
K955683 · RNS STERILE, DISPOSABLE BREAST BIOPSY/LOCALIZATION TRAY
- Nhr, Inc.Mar 31, 1994
K933324 · SKIN BIOPSY DEVICE
- Bip USA, Inc.May 19, 1993
K925870 · SPACER
- Buckman Co., Inc.Mar 31, 1993
K922919 · DYNACYT BIOPSY ASPIRATION DEVICE