Trocar
Cardiovascular · 21 CFR 870.1390
Recent MDR events
1,994 adverse event reports on file
- BRK-1¿ Transseptal Needle, 98 cm LengthJul 29, 2026InjuryAbbott Medical3008452825-2026-00413
- BRK¿ Transseptal Needle, 71 cm LengthJul 27, 2026InjuryAbbott Medical3008452825-2026-00409
- BRK¿ TRANSSEPTAL NEEDLE, 71 CM LENGTHJul 10, 2026InjuryAbbott Medical3008452825-2026-00371
- WINGED GUIDEWIRE INTRODUCER NEEDLE 18GA X 7CMJul 6, 2026MalfunctionArgon Medical Devices, Inc0001625425-2026-00982
- BRK-1¿ XS TRANSSEPTAL NEEDLE, 98 CM LENGTHJul 1, 2026InjuryAbbott Medical3008452825-2026-00356
- BRK¿ XS TRANSSEPTAL NEEDLE, 71 CM LENGTHJun 30, 2026InjuryAbbott Medical3008452825-2026-00350
- BRK¿ TRANSSEPTAL NEEDLE, 71 CM LENGTHJun 23, 2026MalfunctionAbbott Medical3008452825-2026-00322
- BRK¿ TRANSSEPTAL NEEDLE, 98 CM LENGTHJun 17, 2026MalfunctionAbbott Medical3008452825-2026-00344
- TRANSSEPTAL NEEDLE, BRK SERIESJun 12, 2026InjuryAbbott Medical3008452825-2026-00334
- BRK-1¿ XS TRANSSEPTAL NEEDLE, 71 CM LENGTHJun 12, 2026InjuryAbbott Medical3008452825-2026-00335
Event type breakdown
Recalls
11 recall events for this product code
- Cook IncorporatedOpen, ClassifiedApr 12, 2024
Trocar Needle - Used for dilating puncture sites or catheter tracts for percutaneous placement of devices for vascular and non-vascular applications such as in
Packaging may have low seal strength and not meet peel strength specifications, compromising device sterility
Z-1526-2024 · View FDA record ↗ - Cook Inc.TerminatedMar 13, 2019
Cook Transseptal Needle, Reference Number TSNC-18-71.0, Order Number G02364. For transseptal left heart access in both diagnostic and interventional procedures
The products were manufactured without a back bevel on the needle tip. This could cause damage to the inside of the introducer during needle insertion.
Z-0979-2019 · View FDA record ↗ - Instrumed International, Inc.TerminatedDec 16, 2014
A trocar is a sharp-pointed instrument used with a cannula for piercing a vessel or chamber to facilitate insertion of the cannula sold under the Symmetry Surgi
The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did not market these devices prior to September 26, 1976, and therefore, does not meet all FDA requirements to market the devices as "Pre-Amendment" devices.
Z-0535-2015 · View FDA record ↗ - CooperSurgical, Inc. D.B.A. Lone Star Medical ProductsTerminatedOct 29, 2014
Blunt Hurd Cannula Blunt Tip 10 mm with 5 mm Reducer simplifies open laparoscopy.
CooperSurgical is recalling two lots of 900-863 because the wrong package insert (IFU) was placed into the shipper.
Z-0147-2015 · View FDA record ↗ - Medical Device Technologies, Inc.TerminatedJul 13, 2010
Angiotech Vascular Access Needle.
Medical Device Technologies doing business as Angiotech has conducted a recall on Angiotech Breast Localization Needles, Soft Tissue Biopsy Needles, Vascular Access Needles, Bone Biopsy Needles, Access Needles, Galactography Kit, Stabilization Needles and Needle Guides for packaging integrity.
Z-2018-2010 · View FDA record ↗ - Cook Inc.TerminatedUnknown
Transseptal Needle, Trocar. RPN TSNC-18-71.0, TSNC-19-56.0. GPN G02364, G02365.
Transseptal needles may contain rust on the interior and/or exterior of the needle, which may not be detected by the user. Potential adverse events if an affected product is used ranges from increased procedural time to inflammatory reactions, which at their most severe include systemic reactions potentially leading to permanent impairment or death.
Z-0222-2022 · View FDA record ↗ - Ethicon Endo-Surgery IncTerminatedUnknown
ENDOPATH XCEL" with OPTIVIEW" Technology trocar
This recall has been initiated because Ethicon Endo-Surgery is aware of an increase in reports of leaking in the ENDOPATH XCEL" with OPTIVIEW" Technology trocar, which potentially can lead to loss of pneumoperitoneum during a surgical procedure. Pneumoperitoneum leaks may lead to conversion from laparoscopic to open surgery.
Z-0336-2011 · View FDA record ↗ - Merit Medical Systems, Inc.TerminatedUnknown
HeartSpan Transseptal Needles Catalog No. FND-019-01, Lot No. E1913644 consisting of an outer needle cannula and an inner stylet. The needle is comprised of fl
The labeled needle tip curvature of specific lots of transseptal needles may not match the actual needle tip curvature. In the event that the incorrect needle is unknowingly used, an unintended anatomy puncture may occur, which is likely to require medical intervention.
Z-1262-2021 · View FDA record ↗ - Merit Medical Systems, Inc.TerminatedUnknown
Heartspan Transseptal Needles, Catalog No. FND-019-02, Lot No. E1913645 consisting of an outer needle cannula and an inner stylet. The needle is comprised of fl
The labeled needle tip curvature of specific lots of transseptal needles may not match the actual needle tip curvature. In the event that the incorrect needle is unknowingly used, an unintended anatomy puncture may occur, which is likely to require medical intervention.
Z-1263-2021 · View FDA record ↗ - Merit Medical Systems, Inc.TerminatedUnknown
Boston Scientific TSX Transseptal Needle, Model Number M004TSX60o;
Merit Medical Systems, Inc. is voluntarily conducting a recall of one lot of the TSX" Transseptal Needle due to a discrepancy between the labeling and the actual configuration of the device in the packaging. The curve dimensional values on the labels of this lot incorrectly indicate a 50 curve, rather than the correct 86 curve
Z-1375-2016 · View FDA record ↗
Registered firms
109 firms currently registered for this product code
Teleflex Medical Llc
Morrisville, NC, US
Heuer International (a Division Of Gst Corporation Limited)
NOIDA Uttar Pradesh, IN
Sterilization Services Of Virginia
RICHMOND, VA, US
Sterigenics U.s., Llc
Tustin, CA, US
Merit Medical Uk Limited
Earley Reading, GB
Professional Contract Sterilization, Inc.
Taunton, MA, US
Sabin Corporation
Blmgtn, IN, US
Sterigenics Us Llc
Grand Prairie, TX, US
Ambler Surgical, Llc
EXTON, PA, US
Cardinal Health (kenmex Medical Specialties)
TIJUANA Baja California, MX
Tz Medical, Inc.
Tualatin, OR, US
St. Jude Medical, Atrial Fibrillation Division, Inc.
Minnetonka, MN, US
Abbott Medical Costa Rica Ltda.
El Coyol Alajuela, CR
Shanghai Microport Ep Medtech Co., Ltd.
Shanghai, CN
Changzhou Lookmed Medical Instrument Co.,ltd
Changzhou Jiangsu, CN
Busse Hospital Disposables
HAUPPAUGE, NY, US
B. Ali Impex
SIALKOT, Punjab, PK
Medical Components Inc
HARLEYSVILLE, PA, US
Surgipros Llc
Palmetto, FL, US
Sterigenics U.s., Llc
Atlanta, GA, US
Platinum Focus Group Ltd.
London London, City of, GB
Synaptic Medical Limited
Beijing, CN
Quiroproductos De Cuauhtemoc S. De R.l. De C.v.
Cuauhtemoc Chihuahua, MX
Med2b Ltd.
Kitzingen Bavaria, DE
510(k) clearances
51 clearances for this product code
- Synaptic Medical CorporationJul 26, 2024
K240246 · Accusafe Transseptal Guidewire (GTR31180, GTR31230)
- Pressure Products Medical Device Manufacturing, LLCMay 17, 2024
K241042 · SafeSharp Transseptal Needle (CLICK071, CLICK171, CLICK098, CLICK198)
- Pressure Products Medical Device Manufacturing, LLCSep 14, 2022
K221707 · SafeSept® Transseptal Guidewire (SS-140)
- Shanghai Microport EP Medtech Co., Ltd.Mar 23, 2022
K212625 · PathBuilder Transseptal Needle
- Pressure Products Medical Device Manufacturing, LLCMar 5, 2021
K210328 · SafeSept Blunt Needle
- Pressure Products Medical Device Manufacturing, LLCFeb 21, 2018
K172950 · TSN Transseptal Needle
- Pressure Products Medical Device Manufacturing, LLCFeb 16, 2018
K172934 · Needle Free Transseptal Cannula
- Pressure Products Medical Device Manufacturing, LLCDec 21, 2017
K172893 · SafeSept Needle Free Transseptal Guidewire