LimFlow Extension Stent Graft RGS-55200-US-24Recalls & reported problems
Inari Medical, Inc. · LimFlow Extension Stent Graft (5.5 mm x 200 mm). The LimFlow Extension Stent Graft is indicated for patients who have chronic limb-threatening ischemia with no suitable endovascular or surgical revascularization options and are at risk of major amputation. · Class 3 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 5
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00850041730219), received between Oct 17, 2025 and Sep 11, 2026 — classified as 1 injury, 4 malfunctions.
The most frequently reported specific device problem is “Physical Resistance/Sticking” (4 reports).
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.
Reports received per month
Most reported problems
Device problems
- Physical Resistance/Sticking4
- Detachment of Device or Device Component1
- Stretched1
- Therapy Delivered to Incorrect Body Area1
Patient problems
- No Clinical Signs, Symptoms or Conditions5
- Failure of Implant1
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 11, 2026Physical Resistance/Sticking
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50736203 ↗MalfunctionMay 7, 2026Detachment of Device or Device Component
ON (B)(6) 2026, A PATIENT UNDERWENT A PROCEDURE USING THE LIMFLOW SYSTEM OF DEVICES. THE PROCEDURE PROGRESSED SUCCESSFULLY TO STENT DEPLOYMENT. AFTERWARD IT WAS FOUND THAT A PIECE OF THE CATHETER HAD BROKEN OFF INTO THE PATIENT. THE SURGEON WAS ABLE TO REMOVE IT AND COMPLETED THE CASE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25114198 ↗MalfunctionDec 11, 2025Physical Resistance/Sticking; Physical Resistance/Sticking
ON (B)(6) 2025, A PATIENT UNDERWENT TRANSCATHETER ARTERIALIZATION OF DEEP VEIN (TADV) USING LIMFLOW DEVICES. THE LIMFLOW EXTENSION STENT GRAFT, 200MM (RGS-55200-US-24) PARTIALLY DEPLOYED A STENT, REQUIRING THE PHYSICIAN TO DISASSEMBLE THE DEVICE HANDLE AND REMOVE ALL PIECES OF THE DEVICE FROM THE PATIENT. THIS DID NOT RESULT IN ANY PATIENT HARM AND THE PROCEDURE WAS SUCCESSFUL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23785459 ↗MalfunctionDec 3, 2025Physical Resistance/Sticking; Physical Resistance/Sticking
ON (B)(6) 2025, A PATIENT UNDERWENT TRANSCATHETER ARTERIALIZATION OF DEEP VEIN (TADV) USING LIMFLOW DEVICES. THE LIMFLOW EXTENSION STENT GRAFT, 200MM (RGS-55200-US-24) PARTIALLY DEPLOYED A STENT, REQUIRING THE PHYSICIAN TO DISASSEMBLE THE DEVICE HANDLE AND FINISH THE DEPLOYMENT MANUALLY. THIS DID NOT RESULT IN ANY PATIENT HARM AND THE PROCEDURE WAS SUCCESSFUL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23709322 ↗InjuryOct 17, 2025Therapy Delivered to Incorrect Body Area; Stretched; Physical Resistance/Sticking; Therapy Delivered to Incorrect Body Area; Stretched; Physical Resistance/Sticking
ON (B)(6) 2025 DURING A LIMFLOW PROCEDURE, THE MEDICAL TEAM EXPERIENCED ISSUES WITH UNSUCCESSFUL STENT DEPLOYMENTS. AFTER ONE STENT GRAFT SYSTEM NOT DEPLOYING, A SECOND SYSTEM WAS USED. THE SECOND STENT GRAFT SYSTEM DEPLOYED APPROXIMATELY ONE THIRD OF THE WAY BEFORE IT STOPPED DEPLOYING. THE PHYSICIAN ACCESSED THE INSIDE OF THE HANDLE TO ATTEMPT TO MANUALLY DEPLOY THE REST OF THE STENT. WHEN THIS WAS UNSUCCESSFUL, THE PHYSICIAN DECIDED TO PULL THE ENTIRE SYSTEM FROM THE PATIENT RESULTING IN THE STENT STRETCHING AND EXTENDING PAST THE ANASTOMOSIS WITH THE POTENTIAL OF OCCLUDING OTHER VESSELS. TO PREVENT POTENTIAL ACUTE ISCHEMIA, THE PHYSICIAN PROCEEDED WITH FENESTRATING THE STRETCHED STENT PORTIONS ALONG BIFURCATING ARTERIAL VESSELS. ADDITIONALLY, THE STRETCHED PORTIONS OF THE STENT WERE RELINED WITH OTHER STENTS.
Patient problems: Failure of Implant; No Clinical Signs, Symptoms or Conditions
MAUDE report 23328461 ↗
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 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