RAPIDTRANSIT 601-251XRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10886704028352), received between Mar 6, 2017 and Sep 14, 2018 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Physical Resistance” (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

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 14, 2018Physical Resistance/Sticking; Physical Resistance/Sticking

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, DURING A STENT-ASSISTED COIL EMBOLIZATION OF A RECURRENT LEFT OPHTHALMIC ARTERY ANEURYSM, THE 4MM X 30MM ENTERPRISE 2 NO TIP (ENF403000/10689189) STENT WAS LOADED, FLUSHED, AND ADVANCED THROUGH THE 0.021¿ RAPID TRANSIT 150CM (601251X/30042646) DUAL MARKER MICROCATHETER, BUT RESISTANCE WAS ENCOUNTERED ABOUT HALFWAY THROUGH THE MICROCATHETER AND THE STENT COULD NO LONGER BE ADVANCED. THE STENT BECAME STUCK IN THE MICROCATHETER HUB DURING REMOVAL; THEREFORE, THE MICROCATHETER WAS REMOVED FROM THE PATIENT. THE MICROCATHETER AND STENT WERE REPLACED, AND TARGET POSITION WAS EASILY RE-OBTAINED. THE ENTERPRISE 2 STENT WAS IMPLANTED ACROSS THE NECK OF THE ANEURYSM AND FOUR COMPETITOR COILS WERE PLACED IN THE ANEURYSM. POST ANGIOGRAPHY REVEALED GOOD RESULT AND THE CASE WAS CONCLUDED. NO PATIENT COMPLICATIONS OCCURRED AS A RESULT OF THE EVENT. THE SURGERY WAS DELAYED 5-10 MINUTES DUE TO THE EVENT. THE PATIENT DID WELL POST-OP AND WAS DISCHARGED THE FOLLOWING DAY. THE RIGHT FEMORAL ARTERY WAS ACCESSED WITH A 6F SHEATH. THE TARGET ANEURYSM WAS PREVIOUSLY COILED WITH COMPETITOR COILS ONE YEAR PRIOR. THE VESSEL TORTUOSITY WAS LOW. NO VISIBLE PRODUCT DAMAG

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7876803 ↗
• MalfunctionMar 6, 2017Physical Resistance; Physical Resistance

  THE CONTACT FROM THE FACILITY REPORTED THAT THERE WAS STRONG RESISTANCE FELT WHEN ADVANCING THE COIL THROUGH THE MIDDLE PORTION OF THE TRANSIT MICROCATHETER (601251X/17536303.). THE PROCEDURE WAS THE PRE STENT-GRAFTING COIL EMBOLIZATION OF AN ANEURYSM AT THE INTERNAL ILIAC ARTERY. THE PATIENT¿S INFORMATION WAS UNKNOWN. THE PATIENT¿S VESSEL LEVEL OF TORTUOUSNESS AND CALCIFICATION WERE UNKNOWN. NO REPORT OF THE OTHER DEVICE USED IN THE PROCEDURE IS AVAILABLE. THE TRANSIT (COMPLAINT PRODUCT) WAS ADVANCED TO THE SITE OF EMBOLIZATION. THE COIL (PUSHABLE COIL, DETAILS UNKNOWN) WAS INSERTED INTO THE CATHETER BUT THERE WAS STRONG RESISTANCE FELT AT THE MIDDLE PORTION. THE COIL WAS SUCCESSFULLY INSERTED SOMEHOW BUT THE PHYSICIAN FELT THAT IT MAY NOT BE SAFE TO USE. THE CATHETER WAS REPLACED WITH A COMPETITOR MICROCATHETER (DETAILS UNKNOWN.) THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT FURTHER ISSUES OR DELAY. THERE WAS ALSO NO PATIENT INJURY / COMPLICATION REPORTED. THE COMPLAINT PRODUCT WAS NEW AND STORED PER LABELING INSTRUCTIONS. THE PROCEDURE WAS CONDUCTED IN ACCORDANCE WITH THE IFU AND A CONSTANT FLUSH WAS MAINTAINED AT ALL TIMES. THERE WAS NO DELAY GREATER THAN 30 MINUTES DUE TO T

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6382983 ↗