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RAPIDTRANSIT 601-231Recalls & reported problems

Medos International Sàrl · RAPIDTRANSIT Infusion Catheter TIP MARKERS 1 USABLE LENGTH 135 cm DISTAL LENGTH 50 cm DISTAL OD 2.3F (0.75 mm) 2.8F (0.95 mm) .021 Inch (0.5 mm) Contents: 1 Infusion Catheter and 1 Shape Mandrel. Minimum Guiding Catheter I.D. / Dia. .042 Inch (1.1 mm) · Class 2

Adverse event reports
1
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10886704028321), received between Sep 22, 2020 and Sep 22, 2020 — classified as 1 malfunction.

The most frequently reported specific device problem is “Physical Resistance/Sticking” (1 report).

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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Device problems

  • Physical Resistance/Sticking1

Patient problems

  • No Consequences Or Impact To Patient1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • MalfunctionSep 22, 2020Physical Resistance/Sticking; Physical Resistance/Sticking

    AS REPORTED BY THE FIELD, DURING AN EMERGENT COIL EMBOLIZATION, A 135CM RAPID TRANSIT MICROCATHETER (601231, 17740800) WAS USED TO ADVANCE A SNARE (BOSTON SCIENTIFIC) BECAUSE A TARGET, STRYKER COIL (UNKNOWN SIZE) HAD BECOME UNRAVELED. THE SNARE ADVANCED ALONG THE RAPID TRANSIT (COMPLAINT DEVICE), BUT THE SNARE WAS NOT ABLE TO ADVANCE ON THE WAY OF THE COMPLAINT DEVICE. THE PHYSICIAN TRIED SEVERAL TIMES, BUT THE SAME ISSUE CONTINUED. THEREFORE, THE COMPLAINT DEVICE AND THE SNARE WERE REMOVED FROM THE PATIENT. THE COMPLAINT DEVICE WAS REPLACED WITH ANOTHER SAME SIZED MICROCATHETER. THE SNARE ADVANCED ALONG THE MICROCATHETER AND THE COIL WAS REMOVED FROM THE PATIENT. THE PROCEDURE WAS COMPLETED. NO PATIENT INJURY WAS REPORTED. ADDITIONAL INFORMATION RECEIVED INDICATED THAT A DIFFERENT MICROCATHETER BECAME UNRAVELED. THE COIL BECAME UNLABELED INSIDE THE MICROCATHETER FOR COIL EMBOLIZATION. WHEN THE PHYSICIAN TRIED TO INSERT THE MICROCATHETER A LITTLE FURTHER INTO THE ANEURYSM, THE MICROCATHETER FELL OFF AND THE COIL WAS UNLABELED OUTSIDE THE MICROCATHETER. THE PHYSICIAN WENT UP THE COMPLAINT PRODUCT TO REMOVE THE COIL. HOWEVER, THE MEANDERING OF THE BLOOD VESSEL WAS STRAIGHT, AND THE C

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 10567646 ↗

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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.