OptiSeal™ 1000093-004Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00821329600227), received between Nov 10, 2017 and Jun 25, 2021 — classified as 8 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (5 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 16, 2026.

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.

• MalfunctionJun 25, 2021Break; Fracture; Material Integrity Problem; Break; Fracture; Material Integrity Problem

  AS REPORTED: BOTH "WINGS" OF INTRODUCER BROKE OFF WHEN TRYING TO SPILT THE SHEATH. MAIN BODY OF SHEATH HAD TO BE CUT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12064828 ↗
• MalfunctionApr 5, 2021Material Frayed; Material Integrity Problem; Material Frayed; Material Integrity Problem

  WHEN SHEATH WAS SPLIT, IT FRAYED SO THAT A SLIVER OF THE INTRODUCER WAS SHED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11617040 ↗
• MalfunctionDec 4, 2018Leak/Splash; Leak/Splash

  AS REPORTED: BLOOD EGRESS WHEN DILATOR REMOVED AFTER INSERTION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8129363 ↗
• MalfunctionNov 28, 2018Leak/Splash; Leak/Splash

  AS REPORTED THIS SHEATH DID NOT HAVE HOMEOSTASIS. A VERY SLOW/SMALL AMOUNT OF BLOOD EGRESSED. THE BLOOD SLOWLY FILLED THE CUP AREA AN THEN DRIP. THIS HAPPENED AFTER DILATOR WAS REMOVED PRIOR TO LEAD INSERTION. THE INTRODUCER WAS USED AND WHEN LEAD WAS INSERTED THERE WAS HEMOSTASIS. THIS IS A SIMILAR EVENT AS MDR 2183787-2018-00078, MDR 2183787-2018-00079, AND MDR 2183787-2018-00080.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8112011 ↗
• MalfunctionNov 15, 2018Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT INTRA-OPERATIVELY, THE INTRODUCER VALVE HAD BLOOD SLOWLY EGRESSING. THE INTRODUCER REMAINED IN USE FOR THE PROCEDURE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8073923 ↗
• MalfunctionOct 19, 2018Leak/Splash; Leak/Splash

  THE HEMOSTASIS VALVE LEAKED BLOOD. THE VALVE DID NOT MAINTAIN HEMOSTASIS WITHOUT A LEAD INSERTED. THIS IS A SIMILAR EVENT AS MDR 2183787-2018-00079 AND MDR 2183787-2018-00080.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7985313 ↗
• MalfunctionOct 17, 2018Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT DURING USE, THE HEMOSTASIS VALVE LEAKED BLOOD, AND WOULD NOT MAINTAIN HEMOSTASIS WITHOUT A LEAD INSERTED. THE VALVE WAS NOT USED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7973457 ↗
• MalfunctionNov 10, 2017Material Separation; Material Separation

  AS REPORTED MD FOUND PIECE OF VALVE FROM THE SHEATH IN THE POCKET PRIOR PUTTING DEVICE IN POCKET. THE MD NEVER SAW THE PIECE FALL INTO POCKET DURING THE PEEL AWAY PROCESS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7022424 ↗