SUREcore Plus Biopsy Instrument SP-LA18-25Recalls & reported problems

Uro-1, Inc. · The SUREcore Plus Biopsy Instrument, with a length of 25 cm, facilitates biopsy of soft tissue. It consists of a biopsy needle and an instrument ("gun"). The needle is advanced under imaging to the target tissue and the instrument fires the needle into the tissue to obtain a core of tissue. The tissue core is than sent to pathology for analysis. It is a single-use device. · Class 2

Data updated Oct 18, 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 00860014338663), received between Sep 29, 2026 and Sep 29, 2026 — classified as 1 malfunction.

The most frequently reported specific device problem is “Material Twisted/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 18, 2026.

Reports received per month

Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

Material Twisted/Bent1

Patient problems

No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

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

MalfunctionSep 29, 2026Material Twisted/Bent
Disposable biopsy core needle was noted to be bent after use on the patient.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50927400 ↗

Device details

UDI-DI	`00860014338663`
Brand	SUREcore Plus Biopsy Instrument
Model	SP-LA18-25
Company	Uro-1, 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	In Commercial Distribution
Record updated	May 18, 2026

Device type (GMDN): Biopsy gun handpiece, mechanical

A hand-operated, non-electronic, surgical instrument designed to be used with a dedicated disposable biopsy gun needle (not included) for the automatic extraction of a soft-tissue sample from an anatomical structure (a biopsy), while causing minimal surrounding tissue damage, for tissue pathological examination/testing. It has a spring-loaded mechanism with a release trigger intended to accept and operate the cutting mechanism of a percutaneous biopsy needle. It is typically used to obtain samples of soft tissue from the kidneys, prostate, pancreas, liver, and breast, often performed under image guidance. This is a reusable device.

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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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.

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