PINNACLE RSB712Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00389701009148), received between Mar 30, 2020 and Mar 30, 2020 — classified as 1 injury.

The most frequently reported specific device problem is “Material Separation” (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 16, 2026.

Most reported problems

Recent adverse event reports

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

• InjuryMar 30, 2020Material Separation; Material Separation

  ADDITIONAL INFORMATION WAS RECEIVED ON (B)(6)2020 . THE PATIENT HAD RETURNED FOR ADDITIONAL IMAGING. ON (B)(6)2020 HE HAD A PORTABLE CHEST X-RAY PERFORMED FOR HYPOTENSION. ON THE SAME DAY, HE AGAIN HAD A CHEST X-RAY PERFORMED AFTER THE INSERTION OF A CENTRAL LINE. ON (B)(6)2020 THE PATIENT RETURNED FOR THE REMOVAL OF THE IJ TUNNELED HEMODIALYSIS CATHETER WITH NO COMPLICATIONS. ON (B)(6)2020 THE PATIENT WAS ADMITTED TO THE HOSPITAL FOR SHORTNESS OF BREATH AND CHEST PAIN. HE WAS SCHEDULED FOR A CT ANGIO CHEST LOOKING FOR PULMONARY EMBOLUS. HE WAS FOUND TO HAVE BILATERAL PLEURAL EFFUSIONS WITH ASSOCIATED ATELECTASIS. ADDITIONAL INFORMATION WAS RECEIVED ON (B)(6)2020 . THE DOCTOR STATED THAT THE PATIENT HAS NOT BEEN BACK FOR A FOLLOW UP DECLOT PROCEDURE. THE DOCTOR ANTICIPATES THAT THE TIP OF THE SHEATH WILL HAVE A FIBRIN SHEATH FORMED OVER IT AND GROW INTO THE WALL WHERE IT IS LODGED WITH NO COMPLICATIONS.

  Patient problems: Chest Pain; Device Embedded In Tissue or Plaque; Pleural Effusion

  MAUDE report 9897994 ↗