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OptiSeal™ 1003975-004Recalls & reported problems

Greatbatch Ltd · Valved Peelable PTFE Introducer · Class 2

Adverse event reports
1
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00821329601385), received between Jan 15, 2019 and Jan 15, 2019 — classified as 1 malfunction.

The most frequently reported specific device problem is “Fluid/Blood Leak” (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

Device problems

  • Fluid/Blood Leak1

Patient problems

  • No Consequences Or Impact To Patient1

Recent adverse event reports

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

  • MalfunctionJan 15, 2019Fluid/Blood Leak; Fluid/Blood Leak

    IT WAS REPORTED THAT WHEN THEY TOOK THE DILATOR OUT OF THE SHEATH, THE VALVE LEAKED BLOOD THROUGH IT. THE VALVE WAS NOT PREVENTING BLEEDBACK, BUT RATHER JUST ALLOWING BLOOD TO COME THROUGH THE VALVE. THE PHYSICIAN SAID HE HAD TO HURRY AND PUT THE LEAD DOWN QUICKER SINCE IT WAS LEAKING. THERE WAS NO REPORTED IMPACT ON THE PATIENT. THE WAS JUST A NUISANCE FOR THE PHYSICIAN.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 8248877 ↗

Other Introducer, Catheter devices

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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.