Rotarex™S 6 F x 110 cm 80332Recalls & reported problems
Straub Medical AG · The Rotarex™S catheter (gauge 6F; length 110 cm) is over-the-wire, single use, percutaneous device for the treatment of occlusions in arterial vasculature. · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07640142811817), received between Jun 22, 2026 and Jun 22, 2026 — classified as 1 injury.
1 other recall cover devices cleared under the same FDA submission (K172315); 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.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Embolism/Embolus1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJun 22, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THROUGH THE RESULTS OF THE CLINICAL TRIAL (BDPI-25-001) THAT DURING THE INDEX PROCEDURE, THE SUBJECT HAD AN ADVERSE EVENT OF DISTAL EMBOLIZATION. THE ADVERSE EVENT WAS NOT RELATED TO THE STUDY DEVICE AND POSSIBLY RELATED TO THE PROCEDURE. THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.
Patient problems: Embolism/Embolus
MAUDE report 25572819 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K172315. One submission often covers many models, so check the product and lot details in each record.
- Z-1244-2025 · Feb 5, 2025 · Open, ClassifiedRotarex Atherectomy System and Instructions for Use, BD SET Rotarex: S 6 F x 110 cm, REF: 80236; S 6 F x 135 cm, REF: 80237; S 8 F x 85 cm, REF: 80238; S 8 F x 110 cm, REF: 80239
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
- 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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