MicroCross 14 Catheter, 135cm RC-2014Recalls & reported problems
Roxwood Medical, Inc. · 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 00858480007138), received between May 31, 2023 and May 31, 2023 — classified as 1 injury.
The most frequently reported specific device problem is “Material Rupture” (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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Most reported problems
Device problems
- Material Rupture1
Patient problems
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryMay 31, 2023Material Rupture; Material Rupture
IT WAS REPORTED A RC2014 BURST IN THE PATIENT AND CREATED A HOLE IN THE HEART. PER THE PERFUSIONIST, THE RETROGRADE CANNULA WAS EITHER FROZEN OR BURNED DURING A MAZE PROCEDURE. PERFUSIONIST NOTIFIED PHYSICIAN OF HIGH-PRESSURE WITH LOW FLOW (LESS THAN 30CC/MIN) WHILE DELIVERING RETROGRADE CARDIOPLEGIA INTO CORONARY SINUS WITH THE TIP FROZEN/BURNT CAUSED OCCLUSION OF TIP OF THE CANNULAR WHICH CAUSED THE CATHETER TO RUPTURE. THE PATIENT REQUIRED A BOVINE PERICARDIAL PATCH TO REPAIR DAMAGE TO THE ORGAN CAUSED BY THE CANNULA RUPTURING. THE PATIENT WAS DISCHARGED FROM HOSPITAL.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 17031634 ↗
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- WATCHMAN™ TruSeal™ Access System M635TU70020Boston Scientific Corporation · Catheter, percutaneous1 recall11 deaths217 reports
- Lantern Delivery Catheter PXSLIMLAN135T45Penumbra, Inc. · CATHETER, PERCUTANEOUS220 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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