Bridge Plus occlusion balloon 590-002Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00810060550816), received between Dec 24, 2025 and Mar 12, 2026 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Difficult to Advance” (2 reports).

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

• MalfunctionMar 12, 2026Difficult to Advance

  A LEAD EXTRACTION PROCEDURE COMMENCED TO REMOVE A RIGHT VENTRICULAR (RV), RIGHT ATRIAL (RA), AND LEFT VENTRICULAR (LV) LEAD DUE TO CIED SYSTEM/POCKET INFECTION. SPECTRANETICS LLD LEAD LOCKING DEVICES (LLDS) WERE INSERTED INTO EACH LEAD TO PROVIDE TRACTION. DURING PROPHYLACTIC STAGING OF A SPECTRANETICS BRIDGE PLUS OCCLUSION BALLOON DEVICE TO BE USED IN THE EVENT OF AN EMERGENCY, RESISTANCE WAS ENCOUNTERED WHEN TRYING TO INSERT THE BALLOON OVER THE NON-PHILIPS GUIDEWIRE, THE BALLOON WOULD NOT ADVANCE. A SPECTRANETICS BRIDGE OCCLUSION BALLOON WAS ADVANCED SUCCESSFULLY, AND THE PROCEDURE WAS COMPLETED WITH NO REPORTED PATIENT HARM. THIS REPORT CAPTURES THE BRIDGE PLUS BALLOON THAT WOULD NOT ADVANCE OVER THE GUIDEWIRE; POTENTIAL FOR HARM IF IT WAS TO RECUR IN THE EVENT OF AN EMERGENCY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24581953 ↗
• MalfunctionDec 24, 2025Difficult to Advance; Difficult to Advance

  A LEAD EXTRACTION PROCEDURE COMMENCED TO REMOVE A RIGHT VENTRICULAR (RV) LEAD DUE TO NON-FUNCTION. A RIGHT ATRIAL (RA) LEAD WAS PRESENT WITHIN THE PATIENT BUT WAS NOT TARGETED FOR EXTRACTION. A SPECTRANETICS LLD LEAD LOCKING DEVICE WAS INSERTED INTO THE LEAD TO PROVIDE TRACTION. DURING PROPHYLACTIC STAGING OF A SPECTRANETICS BRIDGE PLUS OCCLUSION BALLOON DEVICE TO BE USED IN THE EVENT OF AN EMERGENCY, RESISTANCE WAS ENCOUNTERED WHEN TRYING TO INSERT THE BALLOON OVER THE .035 NON-PHILIPS GUIDEWIRE BUT WAS ABLE TO PROCEED. ONCE REACHING THE HUB OF THE BALLOON, THE GUIDEWIRE WOULD NO LONGER ADVANCE OR EXIT THE END OF THE WIRE PORT, THUS REMOVED FROM THE PATIENT. A SPECTRANETICS BRIDGE OCCLUSION BALLOON WAS ADVANCED SUCCESSFULLY OVER THE GUIDEWIRE. THE PROCEDURE WAS COMPLETED WITH NO REPORTED PATIENT HARM. THIS REPORT CAPTURES THE BRIDGE PLUS BALLOON THAT WOULD NOT ADVANCE OVER THE GUIDEWIRE; POTENTIAL FOR HARM IF IT WAS TO RECUR IN THE EVENT OF AN EMERGENCY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23889079 ↗