BARD® JAVID 007714Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00801741090110), received between Aug 1, 2018 and Mar 15, 2021 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Device Slipped” (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 16, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 15, 2021Nonstandard Device; Device Slipped; Nonstandard Device; Device Slipped

  IT WAS REPORTED THAT DURING CAROTID BYPASS PROCEDURE, THE CLAMP HOLDING THE VESSEL AND SHUNT ALLEGEDLY SLID OF THE SHUNT. IT WAS FURTHER REPORTED THAT THE DEVICE ALLEGEDLY HAD A NONSTANDARD APPEARANCE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11479294 ↗
• InjuryDec 3, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED IN AN ARTICLE FROM THE JOURNAL OF VASCULAR ACCESS TITLED " USE OF A TEMPORARY SHUNT TO PRESERVE THE PATENCY OF A HEMODIALYSIS GRAFT WHILE PERFORMING IPSILATERAL AXILLO-FEMORAL BYPASS " THAT A CAROTID SHUNT WAS PLACED IN A PATIENT WITH A-V GRAFT PRESERVING CONTINUOUS IPSILATERAL UPPER ARM ACCESS FLOW WHEN CONSTRUCTING A UNILATERAL AXILLO-FEMORAL POLYTETRAFLUOROETHYLENE BYPASS OPERATION FOR CRITICAL LIMB ISCHEMIA IN A HEMODIALYSIS PATIENT. HOWEVER, ULTRASOUND IMAGING REVEALED A DECREASE IN BLOOD FLOW THROUGH THE GRAFT, PROBABLY REPRESENTING A PHYSIOLOGIC STEAL SYNDROME WITHOUT CLINICAL PRESENTATION OF WORSENING ARM ISCHEMIA. THE PATIENT WAS DISCHARGED HOME THE FOURTH POST-OPERATIVE DAY WITH A PATENT ACCESS GRAFT. THE A-V GRAFT CONTINUED TO BE USED AS A VASCULAR ACCESS UNTIL 4 MONTHS LATER WHEN IT BECAME THROMBOSED. THE STATUS OF THE PATIENT WAS NOT PROVIDED.

  Patient problems: Thrombosis

  MAUDE report 9404471 ↗
• MalfunctionAug 1, 2018Device Slipped; Device Slipped

  IT WAS REPORTED THAT DURING A CAROTID BYPASS PROCEDURE, THE SMALLER END OF A TAPERED CAROTID SHUNT ALLEGEDLY SLIPPED OUT OF THE CAROTID ARTERY MULTIPLE TIMES. REPORTEDLY, ANOTHER SHUNT WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7740314 ↗