Jawz Endomyocardial Biopsy Forceps 190081Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00886333206827), received between May 30, 2023 and May 30, 2023 — classified as 2 malfunctions.

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

• MalfunctionMay 30, 2023Activation Failure; Physical Resistance/Sticking; Activation Failure; Physical Resistance/Sticking

  "DURING MY CASE ON (B)(6) 2023, ON A PASS OF THE BIOPTOME TO RV, I OPENED AND CLOSED TO TAKE A SAMPLE AND THEN THE BIOPTOME DID NOT RELEASE AND COME OUT. I WAS UNABLE TO LOOSEN AND PULL BACK THE BIOPTOME WITH USUAL MANEUVERS. ALSO THE BIOPTOME JAWS WOULD NOT OPEN WHEN IN THIS POSITION. THERE WAS SIGNIFICANT TENSION (THOUGH NO PULL TO THE RV WALL ON ECHO GUIDANCE AS WE CAN SEE IN SUCH A SITUATION) SO I DID NOT PULL THE BIOPTOME OUT WITH FORCE. WE ENDED UP HAVING TO CUT OFF THE BIOPTOME HANDLE WITH WIRE CLIPPERS, EXCHANGE THE 7FR SHEATH FOR AN 8FR LONG SHEATH AND ADVANCE SHEATH TO TIP OF BIOPTOME UNDER FLUORO GUIDANCE TO RELEASE THE BIOPTOME. WE WERE THEN ABLE TO PULL BACK THE BIOPTOME AND SHEATH AND ABORTED THE PROCEDURE. THERE WAS NOT TISSUE IN THE FORCEPS/BIOPTOME WHEN IT WAS REMOVED. PATIENT ASYMPTOMATIC WITH STABLE VITALS AND NO PERICARDIAL EFFUSION OR OTHER CHANGES ON POST ECHO. PATIENT WAS MONITORED IN PACU AND HAD A FOLLOW UP ASSESSMENT, STABLE."

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 17021391 ↗
• MalfunctionMay 30, 2023Activation Failure; Physical Resistance/Sticking; Activation Failure; Physical Resistance/Sticking

  "ON MY LAST PASS FOR BIOPSIES UNDER ECHO GUIDANCE THE BIOPTOME GOT STUCK IN PRESUMABLY THE RV, AND I WAS UNABLE TO PULL IT BACK WITHOUT SIGNIFICANT RESISTANCE AND COULD NOT OPEN THE JAWS OR MANEUVER IT MUCH. THE PATIENT WENT INTO AN SVT AND FELT VERY UNCOMFORTABLE. DUE TO HER ARRHYTHMIA AND DISCOMFORT, I PULLED THE BIOPTOME WITH SIGNIFICANT TENSION NOTED AT THE TIME AND RETRIEVED A FAIRLY LARGE PIECE OF TISSUE ON THE END THOUGH THE JAWS REMAINED SHUT AND I COULD NOT RELEASE THE TISSUE PIECE. THAT IS STILL ATTACHED TO THE BIOPTOME AND THE DEVICE WAS COLLECTED TO SEND TO THE MANUFACTURER. THE PATIENT IMMEDIATELY FLIPPED OUT OF HER SVT RHYTHM, FELT BETTER AND REMAINED HEMODYNAMICALLY STABLE."

  Patient problems: Insufficient Information; Tachycardia

  MAUDE report 17021210 ↗