D-STAT IPN922573Recalls & reported problems

Teleflex Incorporated · D-Stat Flowable, 5pk, US · Class 3 · Implant

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 10841156109080), received between Jan 23, 2026 and Jan 23, 2026 — classified as 1 malfunction.

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.

Reports received per month

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

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.

MalfunctionJan 23, 2026
SEVERAL TELEFLEX D-STAT FLOWABLE HEMOSTAT PACKAGES NOTED TO HAVE ADDITIONAL LABEL UNDERNEATH THE PACKAGING LABEL. THE LABEL UNDERNEATH STATES SAME DEVICE, LOT#, AND UDI; HOWEVER, EXPIRATION DATE LISTED AS 7-31-2025 VS THE NEW LABEL PLACED OVER TOP AS 11-30-2025.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24162067 ↗

Device details

UDI-DI	`10841156109080`
Brand	D-STAT
Model	IPN922573
Catalog no.	4000
Company	Teleflex Incorporated
Product code	MGB · Device, hemostasis, vascular
Class	Class 3
FDA submission	None listed
Implant	Yes
Rx / OTC	Prescription
Single use	Yes
Sterile	Yes
MRI safety	Labeling does not contain MRI Safety Information
Status	In Commercial Distribution
Record updated	Dec 19, 2023

Device type (GMDN): Collagen haemostatic agent, non-antimicrobial

A bioabsorbable device derived from animal collagen (e.g., bovine or porcine collagen) designed to produce a rapid haemostasis through platelet activation/aggregation (which initiates the haemostatic cascade leading to a fibrin clot) during a surgical procedure. It is applied directly to the wound where it remains to be absorbed by the body; it is not dedicated to a specific anatomy/application and does not contain an antimicrobial agent. It may be supplied as a fibrillar or soft, pliable pad/sponge or loose fibres; it may be applied in combination with fibrin adhesives. This is a single-use 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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.

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