Procure™ 408298Recalls & reported problems

St. Jude Medical, Inc. · Endomycardial Biopsy Forceps · Class 2

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 05415067009562), received between Aug 1, 2018 and Aug 1, 2018 — classified as 1 malfunction.

The most frequently reported specific device problem is “Defective Device” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Device problems

Defective Device1

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.

MalfunctionAug 1, 2018Defective Device
THE BIOPSY FORCEPS STOPPED WORKING IN THE MIDDLE OF A HEART BIOPSY PROCEDURE. REQUIRED A NEW FORCEPS TO BE USED. NO HARM TO THE PT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7742702 ↗

Device details

UDI-DI	`05415067009562`
Brand	Procure™
Model	408298
Company	St. Jude Medical, Inc.
Product code	DWZ · DEVICE, BIOPSY, ENDOMYOCARDIAL
Class	Class 2
FDA submission	K991486
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	Jul 8, 2019

Device type (GMDN): Endomyocardial biopsy forceps, single-use

A sterile grasping instrument designed to obtain tissue samples from the inner walls of the heart (endomyocardium) typically for histopathological examination. It is typically a flexible metal coil or plastic tube with a pair of scissors-like cups with cutting edges around their rims at the distal end which are operated by a handle attached at the proximal end. It is usually introduced percutaneously through the jugular vein or femoral artery (during catheterization). Acquired tissue samples are typically used for assessment of early rejection of a transplanted heart, cardiomyopathy and myocarditis diagnosis, or detection of antracycline cardiotoxicity. This is a single-use device.

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All DEVICE, BIOPSY, ENDOMYOCARDIAL devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.