Guidewire 0.018 4/320cm angled (Straub Medical®) Version 1.0Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 07640142810261), received between Nov 5, 2020 and Aug 26, 2024 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Fracture” (2 reports).

1 other recall cover devices cleared under the same FDA submission (K172315, K211738); 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.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 26, 2024Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A THROMBECTOMY AND ATHERECTOMY PROCEDURE, THE GUIDEWIRE WAS ALLEGEDLY BROKEN AND SEPARATED INTO TWO PARTS. IT WAS FURTHER REPORTED THAT THE SEPARATED PART OF THE GUIDEWIRE WAS REMOVED USING SNARE DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20061962 ↗
• MalfunctionNov 5, 2020Fracture; Fracture; Overheating of Device; Component Missing

  LEFT GROIN TREATING RIGHT LEG. NO ACCESS ISSUES, NO CONCERN ABOUT CASE. CTO DISTAL SFA, DISEASE IN COMMON FEMORAL. CROSSED CTO EASILY. USED IVIS. USED ROTAREX IN COMMON FEM, MOVED TO DISTAL SFA. 2/3 THE WAY THROUGH HIT "ROCK", 80% STENOSED. BOGGED DOWN. CLUTCHED OUT TWICE, THEN PUSHED PAST THE STENOSIS TO TREAT FARTHER DOWN. BACK AND FORTH MOTION PECK MOTION. MOVED AWAY AND DOWN TPT DRUNK. NOTICED SLOWER ASPIRATION BUT WORKING NORMAL. REMOVED DEVICE, SET ASIDE, DIDN'T NOTICE TIP WAS MISSING FROM DEVICE. ROTAREX CATHETER FRACTURE WHEN CROSSING THE BIFURCATION. TROUBLE PUTTING BALLOON INTO SHEATH. LOOKED AT FLOURO - SAW HELIX INSIDE OF SHEATH, STILL ON WIRE BUT DISTAL TO SHEATH. USED SNARE TO REMOVE DEVICE. FRAGMENT WAS 1/3 OF HELIX LENGTH. ALL GOT PUSHED OUT DISTAL TO SHEATH WHEN BALLOON WAS PUT IN. ADDED ~3MIN TO CASE TO RETREIVE DEVICE. 7FR COOK ANSEL SHEATH, NOT A HIGH FLEX. WHEN WIRE PINNED, WHEN FINISHING UP AND GETTING READY TO PULL DEVICE OUT (FINISHING DISTAL TPT TRUNK), THE WIRE STARTED TO FEEL WARM. DEVICE RUNNING WHEN REMOVED THROUGH CTO.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Stenosis

  MAUDE report 10791987 ↗
• MalfunctionNov 5, 2020Fracture; Physical Resistance/Sticking

  STRAIGHT FORWARD CASE. 6F 45 CM FLEX ANSEL UP AND OVER SHEATH WAS USED. A .018 STAUB WIRE ADVANCED ONCE ROTAREX USAGE DETERMINED. ROTAREX 6F 135 REF #(B)(4) LOT# 200541 PRESENTED FOR ISR AND IN BETWEEN THE 2 SFA/POP STENTS. DOC AWARE OF OFF LABEL INDICATION. DR. CARTER TREATED THE 2 STENTS AND THE GAP IN BETWEEN STENTS. DURING PROCEDURE THE ROTAREX CLUTCHED OUT ONE TIME, DOC BACKED UP AND REENGAGED LESION. TERRIFIC RESULTS. REMOVED ROTAREX AND INSPECTED. INTACT. UPON INTRODUCING AN ULTRAVERSE 5X150 PTA, PTA WOULDN'T ADVANCE. NOTICED THE PROXIMAL TIP OF WIRE HAD FRACTURED. THE FRACTURED PORTION OF THE PROXIMAL 30CM PORTION OF WIRE WAS IN THE PROXIMAL SFA. PHYSICIAN SNARED WIRE PORTION WITH NO COMPLICATION. CASE WAS COMPLETED WITH .035 WIRE, PTA AND STENTING. EXCELLENT RESULT. PHYSICIAN SAID ABSOLUTELY NO ISSUE WITH DEVICE. COMLAINED IS GUIDEWIRE WHICH IS PART OF SET ROTAREXS 6F 135CM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10791442 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K172315, K211738. One submission often covers many models, so check the product and lot details in each record.

• Z-1244-2025 · Feb 5, 2025 · Open, Classified
  Rotarex 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