VASCU-SHEATH® DMR1903424SRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00884908144598), received between Jul 10, 2026 and Jul 10, 2026 — classified as 1 injury.

The most frequently reported specific device problem is “Break” (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 18, 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.

• InjuryJul 10, 2026Break

  2.6 FR MEDCOMP PICC ATTEMPTED USING THE 3 FR MST KIT. LEFT CEPHALIC MEETING CATHETER TO VEIN RATIO WAS ACCESSED WITH 1 ATTEMPT USING ULTRASOUND. NO DIFFICULTY PLACING THE GUIDEWIRE AND PEEL AWAY INTRODUCER. PICC WOULD NOT THREAD PAST 4 CM AND PICC INSERTION ABORTED. FOLLOWING PICC LINE ATTEMPT, A SMALL WIRE WAS CAPTURED ON XRAY IN THE LEFT ARM OF THE PATIENT JUST PROXIMAL TO THE INSERTION SITE WHERE THE PICC LINE WAS ATTEMPTED. THE WIRE WAS NOT NOTED ON RADIOLOGY READS IN THEIR DICTATION. ON (B)(6) 2026 THE PARENT NOTED A DARK SPOT ON THE PATIENT AND FELT AN OBJECT SLIGHTLY PROTRUDING FROM BELOW THE SKIN WHICH SHE PULLED ON AND SUBSEQUENTLY REMOVED A 2 CM WIRE. SHE REPORTED THE WIRE WAS PROTRUDING FROM A SITE LATERAL TO THE BICEPS, A FEW CENTIMETERS AWAY FROM SMALL, NEEDLE-POINT SIZED SCAR OVER THE INNER LEFT UPPER ARM.

  Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

  MAUDE report 25778768 ↗