Xcela 45713Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI H965457130), received between Apr 12, 2016 and Apr 12, 2016 — classified as 1 injury.

The most frequently reported specific device problem is “Knotted” (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

Recent adverse event reports

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

• InjuryApr 12, 2016Knotted; Retraction Problem; Uncoiled; Knotted; Retraction Problem; Uncoiled

  RECEIVED FROM FDA VIA USER MEDWATCH (B)(4): EVENT DESCRIPTION: NOTES FROM THE INTERVENTIONAL RADIOLOGIST: " DURING PICC PLACEMENT, THE WIRE BECAME KNOTTED WITHIN A SMALL COLLATERAL VEIN OF THE RIGHT UPPER EXTREMITY. THE INTERVENTIONAL RADIOLOGY TECHNOLOGIST OBTAINED FOR ACCESS TO THE LEFT BRACHIAL VEIN USING REAL-TIME ULTRASOUND GUIDANCE AND A MICROPUNCTURE KIT. THE NEEDLE TIP POSITION CONFIRMED WITH ULTRASOUND. HOWEVER, UPON ADVANCING THE WIRE, THE WIRE REPORTEDLY BECAME COILED IN THE VEIN AND COULD NOT BE REMOVED...THE WIRE WAS LODGED AT ITS DISTAL TIP AND THE WIRE WAS DEBRAIDED AT THE ACCESS SITE. AT THIS TIME, THE RIGHT GROIN WAS PREPPED AND DRAPED... PERCUTANEOUS ACCESS TO THE RIGHT COMMON FEMORAL VEIN WAS OBTAINED WITH A MICROPUNCTURE SET USING ULTRASOUND GUIDANCE. AN ULTRASOUND IMAGE WAS OBTAINED AND ARCHIVED. USING 0.035 GLIDEWIRE BERENSTEIN CATHETER, ACCESS TO THE LEFT BRACHIAL VEIN WAS OBTAINED. A VENOGRAM WAS PERFORMED DEMONSTRATING THE LODGED WIRE TO BE WITHIN A COLLATERAL VEIN EMANATING FROM THE BRACHIAL VEIN. ACCESS WITH COLLATERAL VEIN WAS ULTIMATELY OBTAINED WITH A WIRE AND CATHETER. SNARING OF THE WIRE WAS ATTEMPTED BUT UNSUCCESSFUL. THEREFORE, GIVEN THE INABILITY

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5570613 ↗