Recanalization System BDRECANSYSTEMRecalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00801741202421), received between Feb 23, 2024 and Jan 9, 2026 — classified as 8 malfunctions.

The most frequently reported specific device problem is “Problem with Software Installation” (7 reports).

1 FDA recall record name this device's identifier, 1 still open.

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.

Recalls naming this device

1. Nov 14, 2023Open, Classified

   Recanalization systems may be in a manufacturing mode that allows the system to continuously run without the typical 30 second pauses, and 4-minute warning/5-minute restart required messages to indicate the ten-minute maximum catheter use time has been exceeded, which may increase the risk of the device overheating or breaking.

   Z-0676-2024 · Root cause: Process design · FDA record ↗

Most reported problems

Recent adverse event reports

The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 9, 2026Missing Information

  IT WAS REPORTED THAT THERE ARE NO ALLEGED ISSUES WITH THIS BDRECANSYSTEM. THIS DEVICE IS BEING RETURNED TO SERVICE CENTER TO GET THE LATEST SOFTWARE VERSION UPDATE. THERE IS NO PATIENT INVOLVEMENT. DURING EVALUATION, IT WAS IDENTIFIED THAT THE BDRECANSYSTEM'S PRODUCT LABEL WAS MISSING. THE 6-32 X 1/4 PAN HEAD SCREW IS ATTACHED TO THE DEVICE IN A ZIPLOC BAG, AND THE PEM NUT IS SCREWED ONTO THE PAN HEAD SCREW. THE CABLE TIE HOLDER THAT HOLDS THE PUMP CABLE FERRITE BEAD IS LOOSE FROM THE DOUBLE-SIDED TAPE. THE BACK PLATE DOES NOT HAVE PEM NUTS. THE POWER ENTRY PLATE PEM NUT IS DISLODGED AND THREADED ONTO THE PAN HEAD SCREW.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24016868 ↗
• MalfunctionMar 4, 2025Problem with Software Installation; Problem with Software Installation

  IT WAS REPORTED THAT DEVICE COULD POTENTIALLY BE IN THE INCORRECT MODE AND RECALL WAS INITIATED TO ENSURE ALL DEVICES WERE TESTED. AT THIS TIME, THERE ARE NO ALLEGED ISSUES WITH THE DEVICE. IT WAS FURTHER REPORTED THAT AFTER THE DEVICE WAS RETURNED TO THE SERVICE CENTER, DURING THE EVALUATION THE DEVICE WAS FOUND TO BE IN THE INCORRECT EMC MODE. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21511963 ↗
• MalfunctionNov 26, 2024Problem with Software Installation; Problem with Software Installation

  IT WAS REPORTED THAT THE DEVICE COULD POTENTIALLY BE IN THE INCORRECT MODE AND RECALL WAS INITIATED TO ENSURE ALL DEVICES WERE TESTED. IT WAS FURTHER REPORTED THAT AT THIS TIME, THERE ARE NO ALLEGED ISSUES WITH THE DEVICE. HOWEVER, DURING EVALUATION THE DEVICE WAS FOUND TO BE IN EMC MODE. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20787082 ↗
• MalfunctionApr 8, 2024Accessory Incompatible; Device Alarm System; Computer Software Problem; Problem with Software Installation; No Apparent Adverse Event; Accessory Incompatible; Device Alarm System; Computer Software Problem; Problem with Software Installation; No Apparent Adverse Event

  IT WAS REPORTED THAT PRIOR TO A RECANALIZATION PROCEDURE, THE SYSTEM SHOWED A CONNECTION ERROR. UPON RECONNECTING THE CATHETER, THE DEVICE DISPLAYED "SYSTEM MALFUNCTION SERVICE REQUIRED" MESSAGE. IT WAS FURTHER REPORTED THAT THERE WAS A LEAKAGE FROM THE CONNECTION PART OF THE CATHETERS AND CAPITAL EQUIPMENT UNIT. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19066250 ↗
• MalfunctionMar 7, 2024Problem with Software Installation; Problem with Software Installation

  IT WAS REPORTED THAT THE DEVICE WAS RETURNED TO THE SERVICING CENTER DUE TO A FIELD ACTION RECALL. DURING THE SERVICING CENTER¿S INCOMING INSPECTION PROCESS, IT WAS IDENTIFIED THAT THE SYSTEM WAS RETURNED IN THE EMC/VCP MODE, RATHER THAN THE NORMAL MODE. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18857324 ↗
• MalfunctionMar 7, 2024Problem with Software Installation; Problem with Software Installation

  IT WAS REPORTED THAT THE DEVICE WAS RETURNED TO THE SERVICING CENTER DUE TO A FIELD ACTION RECALL. DURING THE SERVICING CENTER¿S INCOMING INSPECTION PROCESS, IT WAS IDENTIFIED THAT THE SYSTEM WAS RETURNED IN THE EMC/VCP MODE, RATHER THAN THE NORMAL MODE. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18857105 ↗
• MalfunctionFeb 23, 2024Problem with Software Installation; Problem with Software Installation

  IT WAS REPORTED THAT PRIOR TO A RECANALIZATION PROCEDURE, THE DEVICE HAD NO KNOWN ISSUES. IT WAS FURTHER REPORTED THAT DURING SERVICE EVALUATION IT WAS IDENTIFIED THAT DEVICE WAS ALLEGEDLY RECEIVED NOT IN NORMAL MODE BUT WAS IN EMC/VCP MANUFACTURING MODE. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18773619 ↗
• MalfunctionFeb 23, 2024Problem with Software Installation; Problem with Software Installation

  IT WAS REPORTED THAT FIELD INVENTORY WAS RETURNING THIS TRUNK STOCK DEVICE WITH NO ALLEGED ISSUES. DURING THE SERVICING CENTER¿S INCOMING INSPECTION PROCESS, IT WAS IDENTIFIED THAT THE SYSTEM WAS RETURNED IN THE EMC/VCP MODE, RATHER THAN THE NORMAL MODE. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18773618 ↗