2F AND 3F VASCU-SHEATH TEARAWAY INTRODUCER2F AND 3F VASCU-SHEATH TEARAWAY INTROD MR190521Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00884908087666), received between Sep 18, 2018 and Nov 21, 2018 — classified as 2 injuries.

The most frequently reported specific device problem is “Break” (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.

• InjuryNov 21, 2018Break; Break

  MICROWIRE GOT STUCK DURING SELDINGER TECHNIQUE AND UNRAVELED DURING REMOVAL. A SMALL PART OF THE WIRE WAS LEFT INSIDE THE SOFT TISSUE OF THE PATIENT'S GROIN.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 8095097 ↗
• InjurySep 18, 2018Break; Break

  WHILE ATTEMPTING TO GAIN ACCESS TO THE RIGHT INTERNAL JUGULAR VEIN EXPERIENCED WIRE AND INTRODUCER NEEDLE MISCOMMUNICATION. THE WIRE AND NEEDLE BECAME TWISTED TOGETHER AND DIFFICULT TO SEPARATE. MULTIPLE UNSUCCESSFUL ATTEMPTS WERE MADE TO SEPARATE THE TWO BY ADVANCING AND PULL BACK ON THE WIRE TO FREE IT FROM THE NEEDLE. IN AN ATTEMPT TO REMOVE THE WIRE AND THE NEEDLE OUT OF THE BODY SIMULTANEOUSLY THE TIP OF THE WIRE BROKE AND BEGAN TO UNRAVEL. SEVERAL ATTEMPTS WERE MADE TO RETRIEVE THE REMAINING 1.0 TO 1.5 CM PORTION OF WIRE. ULTIMATELY IT WAS DECIDED THAT IT WAS SAFER TO LEAVE IT IN THE PATIENT'S CHEST WALL. THE PATIENT WAS TRANSFERRED TO PACU IN SATISFACTORY CONDITION.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 7885744 ↗