PhD™ 00884450746714Recalls & reported problems

1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.

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

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00884450746714), received between Aug 28, 2024 and Aug 28, 2024 — classified as 1 malfunction.

1 FDA recall record name this device's identifier, 1 still open.

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.

Reports received per month

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

Recalls naming this device

Aug 4, 2025Open, Classified
Hemostasis valve has a manufacturing defect and when used the valve cap may remain depressed, leading to potential leakage, which may result in procedure inconvenience and/or hemorrhage.
Z-0533-2026 · Root cause: Process change control · FDA record ↗

Most reported problems

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.

MalfunctionAug 28, 2024
ELDERLY MALE WITH HISTORY OF CORONARY BYPASS GRAFT AND RECENT CHEST PAIN. PROCEDURE: LEFT HEART CATHETERIZATION. THE BACK END OF THE DEVICE IS SOLID- THERE IS NO OPENING FOR WIRE TO COME OUT. NO KNOWN HARM TO PATIENT. MANUFACTURER RESPONSE FOR ADAPTOR, STOPCOCK, MANIFOLD, FITTING, CARDIOPULMONARY BYPASS, PHD (PER SITE REPORTER), WILL OBTAIN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20085016 ↗

Device details

UDI-DI	`00884450746714`
Brand	PhD™
Model	00884450746714
Catalog no.	MAP800/B
Company	Merit Medical Systems, Inc.
Product code	DTL · Adaptor, stopcock, manifold, fitting, cardiopulmonary bypass
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	Sep 15, 2023

Device type (GMDN): Angiography kit

A collection of sterile devices and equipment used to prepare a patient for the radiographic visualization of the arteries of a particular organ system or body part through the vascular injection of contrast media. It typically includes a combination of fluid/contrast media administration devices (e.g., tubing, manifold, stopcocks, and syringes) and/or dedicated angiography supportive devices (e.g., angiography drapes, covers, dressings); the angiography catheter is not included. This is a single-use device.

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All Adaptor, stopcock, manifold, fitting, cardiopulmonary bypass devices →

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