Flo-Rester® Disposable Internal Vessel Occluder 60100Recalls & 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

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. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

Feb 22, 2024Open, 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-1523-2024 · Root cause: Under Investigation by firm · 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	`00085412532042`
Brand	Flo-Rester® Disposable Internal Vessel Occluder
Model	60100
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.

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All CLAMP, VASCULAR devices →

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