Flo-Thru Intraluminal ShuntRecalls & reported problems across all models
Synovis Life Technologies, Inc. · 9 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
1 open recall names at least one Flo-Thru Intraluminal Shunt model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls
- 1
We found 9 models of Flo-Thru Intraluminal Shunt by Synovis Life Technologies, Inc. in the FDA's device registry (GUDID). Together they are named in 2 adverse event reports in the FDA's MAUDE database, received between Apr 24, 2023 and Sep 27, 2024 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Device Contamination with Chemical or Other Material” (1 report).
1 FDA recall record name at least one of these models by its device 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Flo-Thru Intraluminal Shunt recalls
FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.
- 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-1522-2024 · Root cause: Under Investigation by firm · names 9 of these models · Recall details · FDA record ↗
Most reported Flo-Thru Intraluminal Shunt problems
Device problems
- Device Contamination with Chemical or Other Material1
- Positioning Failure1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Flo-Thru Intraluminal Shunt models
9 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Flo-Thru Intraluminal Shunt® FT-12125CLAMP, VASCULAR1 recall1 report
- Flo-Thru Intraluminal Shunt® FT-12225CLAMP, VASCULAR1 recall1 report
- Flo-Thru Intraluminal Shunt® FT-12100CLAMP, VASCULAR1 recall0 reports
- Flo-Thru Intraluminal Shunt® FT-12150CLAMP, VASCULAR1 recall0 reports
- Flo-Thru Intraluminal Shunt® FT-12175CLAMP, VASCULAR1 recall0 reports
- Flo-Thru Intraluminal Shunt® FT-12200CLAMP, VASCULAR1 recall0 reports
- Flo-Thru Intraluminal Shunt® FT-12250CLAMP, VASCULAR1 recall0 reports
- Flo-Thru Intraluminal Shunt® FT-12275CLAMP, VASCULAR1 recall0 reports
- Flo-Thru Intraluminal Shunt® FT-12300CLAMP, VASCULAR1 recall0 reports
Recent Flo-Thru Intraluminal Shunt adverse event reports
The 2 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionSep 27, 2024Positioning Failure; Positioning Failure
IT WAS REPORTED THAT THE WHITE THREAD (TETHER) OF A FLO-THRU INTRALUMINAL WAS NOT CENTERED ON THE BLUE TUBE. THE SURGEON DISCOVERED THIS PROBLEM WHEN THEY WERE ABOUT TO PLACE IT INSIDE THE PATIENT DURING OPERATION; HOWEVER, IT WAS NOT USED ON THE PATIENT. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20321849 ↗MalfunctionApr 24, 2023Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
IT WAS REPORTED THAT A FTIS 2.25/12MM HAD LINT IN THE INNER POUCH. THIS ISSUE WAS IDENTIFIED DURING INSPECTION. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16798416 ↗
Other Synovis Life Technologies, Inc. products
All Synovis Life Technologies, Inc. devices →Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- 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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