VACORA® VC10118PRecalls & reported problems

Bard Peripheral Vascular, Inc. · VACORA® Vacuum Assisted Biopsy System, Coaxial Cannula, 10G x 118mm · Class 2

All models of VACORA (7)

Data updated Oct 16, 2026 from official FDA records · Editorial policy

Adverse event reports: 1
Deaths reported: 0
Injuries reported: 0
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00801741079573), received between May 11, 2018 and May 11, 2018 — classified as 1 malfunction.

The most frequently reported specific device problem is “Bent” (1 report).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Device problems

Bent1
Material Twisted/Bent1

Patient problems

No Consequences Or Impact To Patient1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

MalfunctionMay 11, 2018Bent; Material Twisted/Bent; Bent; Material Twisted/Bent
IT WAS REPORTED THAT DURING A STEREOTACTIC BREAST BIOPSY, THE COAXIAL CANNULA WAS ALLEGEDLY BENT INSIDE THE PATIENT. IT WAS FURTHER REPORTED THAT THERE WERE ENOUGH SAMPLES TO COMPLETE THE PROCEDURE. REPORTEDLY, THE COAXIAL WAS UNABLE TO BE USED TO GUIDE THE MARKER PLACEMENT. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7509240 ↗

Device details

UDI-DI	`00801741079573`
Brand	VACORA®
Model	VC10118P
Company	Bard Peripheral Vascular, Inc.
Product code	KNW · INSTRUMENT, BIOPSY
Class	Class 2
FDA submission	None listed
Implant	No
Rx / OTC	Prescription
Single use	Yes
Sterile	Yes
MRI safety	Labeling does not contain MRI Safety Information
Status	Not in Commercial Distribution
Record updated	Apr 17, 2024

Device type (GMDN): Needle guide, single-use

A rigid, non-powered device designed to direct a sharp needle (not included) into its proper course when performing a clinical and/or surgical procedure; the guide itself is not intended for percutaneous access (not a guide-catheter). Dedicated needle guides are available for different procedures such as urethral injections, image-guided (e.g., ultrasound, MRI) transrectal/transperineal prostate biopsy or ablation, endocavity IVF procedures, percutaneous punctures, nerve blocks, electromagnetic device tracking surgery, and stereotactic breast biopsies. Procedural supportive devices (e.g., ultrasound transducer cover/sheath, drape) may be included with the device. This is a single-use device.

Other INSTRUMENT, BIOPSY devices

MAX-CORE MC1616
Bard Peripheral Vascular, Inc. · INSTRUMENT, BIOPSY
1 recall4,258 reports
ENCOR® ECP017G
Senorx, Inc. · INSTRUMENT, BIOPSY
1 recall4,186 reports
MAX-CORE MC1820
Bard Peripheral Vascular, Inc. · INSTRUMENT, BIOPSY
1 recall2,404 reports
MAX-CORE MC1816
Bard Peripheral Vascular, Inc. · INSTRUMENT, BIOPSY
1 recall1 death848 reports
MAX-CORE MC1410
Bard Peripheral Vascular, Inc. · INSTRUMENT, BIOPSY
1 recall399 reports
MAX-CORE MC1610
Bard Peripheral Vascular, Inc. · INSTRUMENT, BIOPSY
1 recall394 reports
ENCOR® ECP0110GV
Senorx, Inc. · INSTRUMENT, BIOPSY
392 reports
ENCOR® ECP0110G
Senorx, Inc. · INSTRUMENT, BIOPSY
390 reports

All INSTRUMENT, BIOPSY devices →

Sources and updates

Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.

How reports and recalls are matched · Editorial policy · Report an error on this page