SET Rotarex™S 8 F x 110 cm 80239Recalls & reported problems
Straub Medical AG · Rotational Excisional Atherectomy System. The Catheter Set includes one Rotarex™S catheter (gauge 8F; length 110 cm), one guidewire (0.018” diameter; 270cm in length), one drape and one collecting bag. · Class 2
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
- 2
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07640142811886), received between Oct 22, 2025 and Mar 3, 2026 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Deformation Due to Compressive Stress” (1 report).
1 FDA recall record name this device's 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, 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
Recalls naming this device
- Feb 5, 2025Class IOpen, Classified
Atherectomy Catheter eIFU updated to clarify and emphasize procedural steps intended to reduce the likelihood of catheter breakage events. Catheter has an outer cylinder connected to a rotating helix, which could fracture and/or break, which would require retrieval, and helix facture/break could cause vessel injury and lead to severe bleeding.
Z-1244-2025 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
Most reported problems
Device problems
- Deformation Due to Compressive Stress1
- Leak/Splash1
- Physical Resistance/Sticking1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
- Perforation of Vessels1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 3, 2026Leak/Splash; Deformation Due to Compressive Stress
ON (B)(6) 2026, A PATIENT UNDERWENT A THROMBECTOMY AND ATHERECTOMY PROCEDURE USING THE ROTAREX DEVICE. DURING THE PROCEDURE, IT WAS REPORTED THAT THE BLOOD WAS NOTED TO BE LEAKING FROM THE METAL PORTION OF THE CATHETER LOCATED ABOVE THE HANDLE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24492919 ↗InjuryOct 22, 2025Physical Resistance/Sticking; Physical Resistance/Sticking
ON (B)(6) 2025, A PATIENT UNDERWENT THROMBECTOMY AND ATHERECTOMY PROCEDURE USING A ROTAREX DEVICE. IT WAS REPORTED THAT ONE 8F ROTAREX GOT STUCK ON THE WIRE. THERE WAS AN ILIAC PERF AND THEY LOST WIRE ACCESS. THE PATIENT WAS SENT TO SURGERY TO REPAIR THE ILIAC. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.
Patient problems: Perforation of Vessels
MAUDE report 23356367 ↗
Other Catheter, Peripheral, Atherectomy devices
- HawkOne™ H1-MCovidien LP · Catheter, peripheral, atherectomy1 recall367 reports
- JETSTREAM™ XC 112266-001Boston Scientific Corporation · Catheter, peripheral, atherectomy288 reports
- JETSTREAM™ XC 112264-001Boston Scientific Corporation · Catheter, peripheral, atherectomy262 reports
- SET Rotarex®S 6F 135cm (Straub Medical®) Version 1.0Straub Medical AG · Catheter, Peripheral, Atherectomy2 deaths206 reports
- SET Rotarex™S 6 F x 135 cm 80237Straub Medical AG · Catheter, Peripheral, Atherectomy1 recall79 reports
- HawkOne™ H1-SCovidien LP · Catheter, peripheral, atherectomy1 recall70 reports
- Turbo-Elite Laser Atherectomy Catheter 420-006Spectranetics Corporation · Catheter, Peripheral, Atherectomy2 recalls19 reports
- Turbo-Elite Laser Atherectomy Catheter 417-152Spectranetics Corporation · Catheter, Peripheral, Atherectomy2 recalls16 reports
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 · 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.
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