Flo-Rester® Disposable Internal Vessel Occluder 50100Recalls & reported problems

Synovis Life Technologies, Inc. · Flo-Rester is a sterile, single use, disposable occluder composed of two silicone rubber bulbs on the distal ends of a flexible shaft. A tab on a tether is attached to the midpoint of the flexible shaft forming a T configuration. Flo-Rester bulbs and tab are radiopaque. · Class 2

All models of Flo-Rester Disposable Internal Vessel Occluder (24)

Data updated Oct 18, 2026 from official FDA records · Editorial policy

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

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

Summary

No MAUDE adverse event reports in our data reference this device identifier directly.

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

1 other recall cover devices cleared under the same FDA submission (K883696); they may or may not involve this specific model.

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.

Recalls naming this device

Feb 22, 2024Class IIOpen, Classified
The Surgical Tools and Cardiovascular Specialty marketing brochures distributed for Flo-Rester Disposable Internal Vessel Occluder, Flo-Thru Intraluminal Shunt, and Vascular Probe Intravascular Probe contain inaccurate content that does not align with the products Instructions for Use (IFU).
Z-1524-2024 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K883696. One submission often covers many models, so check the product and lot details in each record.

Z-0656-2024 · Dec 6, 2023 · Open, Classified
Baxter Flo-Rester, Disposable internal vessel occluder, distributed in the following sizes: a) Product Code 50100: 12MM, 1.00 MM GLOBAL; b) Product Code 50150: 12MM, 1.50 MM GLO

Device details

UDI-DI	`00085412531908`
Brand	Flo-Rester® Disposable Internal Vessel Occluder
Model	50100
Company	Synovis Life Technologies, Inc.
Product code	DXC · CLAMP, VASCULAR
Class	Class 2
FDA submission	K883696
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	Feb 19, 2021

Device type (GMDN): Intravascular anastomosis occluder

A device designed to temporarily occlude the flow of blood in the lumen of a blood vessel at a vascular anastomosis, primarily to control bleeding and enable operative field visualization during coronary or peripheral vascular bypass grafting and vessel repair surgery. It is typically designed as a flexible shaft with dilated/bulbous ends that is entirely inserted into the vessel lumen via a small incision at the surgical site to arrest blood flow at the anastomosis; it will typically have an external tab or tether used for its removal. It is typically made of silicone elastomer and polyester radiopaque materials and is available in a range of diameters. This is a single-use device.

Other CLAMP, VASCULAR devices

Heartstring III System 3.8MM HSK-3038
Maquet Cardiovascular LLC · Clamp, Vascular
1 recall4 deaths809 reports
Heartstring III System 4.3MM HSK-3043
Maquet Cardiovascular LLC · Clamp, Vascular
1 recall265 reports
TR BAND TRB24-REG
Terumo Medical Corporation · CLAMP, VASCULAR
284 reports
TR BAND TRB24-REG
Terumo Medical Corporation · CLAMP, VASCULAR
256 reports
HeartString III Proximal Seal HS-3045
Maquet Cardiovascular LLC · Clamp, Vascular
1 recall187 reports
TR BAND TRB29-LRG
Terumo Medical Corporation · CLAMP, VASCULAR
67 reports
TR BAND TRB29-LRG
Terumo Medical Corporation · CLAMP, VASCULAR
65 reports
Flo-Thru Intraluminal Shunt® FT-12225
Synovis Life Technologies, Inc. · CLAMP, VASCULAR
1 recall1 report

All CLAMP, VASCULAR 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
Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026 · each recall links to the FDA recall notice
Page last rebuilt: Oct 18, 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