BIPAL 502402BRecalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 20705032054956), received between Feb 17, 2017 and Mar 14, 2023 — classified as 2 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Difficult to Remove” (4 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 14, 2023Difficult to Remove; Difficult to Remove

  AS REPORTED, WHEN ATTEMPTING TO OBTAIN THE FIRST MYOCARDIAL SAMPLE IN THE RIGHT VENTRICLE WITH A 7F 50CM 2.2MM JAW BIPAL BIOPSY FORCEPS, A BITE WAS MADE BUT IT WAS REPORTED THAT THE JAWS WOULD NOT OPEN AFTER MAKING THE INITIAL BITE INTO THE RIGHT VENTRICLE AND THE DEVICE WAS STUCK TO THE RIGHT VENTRICLE WHICH WAS CONFIRMED UNDER FLUOROSCOPY. THE DEVICE WAS ABLE TO BE MANIPULATED AND REMOVED WITH THE SAMPLE STILL HELD WITHIN THE JAWS OF THE FORCEPS. AFTER REMOVAL OF THE DEVICE, AN ATTEMPT TO OPEN THE JAWS WAS MADE ON THE BACK TABLE, BUT THE JAWS WOULD NOT OPEN. THE PATIENT WAS IN STABLE CONDITION AFTER THE PROCEDURE AND A FOLLOW UP ECHOCARDIOGRAM WAS PERFORMED TO CONFIRM THERE WERE NO OTHER COMPLICATIONS. THIS WAS DURING A POST-TRANSPLANT MYOCARDIAL BIOPSY IN WHICH THE RIGHT INTERNAL JUGULAR VEIN WAS USED FOR ACCESS. THERE WAS NO TORTUOSITY OR CALCIFICATION OF THE ACCESS VESSEL. THE DEVICE WAS PREPPED PER THE INSTRUCTIONS FOR USE (IFU) AND THERE WAS NEVER AN ATTEMPT TO SHAPE THE DEVICE. ADDITIONALLY, THE JAWS OF THE DEVICE WERE TESTED PRIOR TO INSERTION AND THERE WERE NO APPARENT ISSUES AT THIS TIME. THE DEVICE WAS NOT RETURNED AS EXPECTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16538508 ↗
• MalfunctionMar 13, 2023Mechanical Jam; Physical Resistance/Sticking

  PATIENT PRESENTED FOR ROUTINE ENDOMYOCARDIAL BIOPSY POST CARDIAC TRANSPLANT. 7F CORDIS 50CM BIOTOME WAS USED FOR THE PROCEDURE. RIGHT INTERNAL JUGULAR VEIN (IJ) ACCESS WAS OBTAINED WITHOUT ISSUE. AFTER TAKING FIRST ENDOMYOCARDIAL BIOPSY SAMPLE, CORDIS BIOTOME COULD NOT BE REMOVED WITHOUT FEELING RESISTANCE. MULTIPLE ATTEMPTS WERE MADE TO OPEN BIOTOME JAWS BUT UNDER FLURO, THE BIOTOME JAWS WOULD NOT OPEN. FINALLY, THE BIOTOME WAS SUCCESSFULLY REMOVED AFTER FURTHER MANIPULATION. EVEN OUTSIDE THE PATIENT'S BODY, THE BIOTOME JAWS WOULD NOT OPEN OR RELEASE THE SAMPLE. MANUFACTURER RESPONSE FOR TUBING, PUMP, CARDIOPULMONARY BYPASS, BIPAL (PER SITE REPORTER). AWAITING A MEETING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16529012 ↗
• InjuryMar 10, 2023Difficult to Remove; Difficult to Remove

  AS REPORTED, DURING THE USE OF A 7F 50CM 2.2MM JAW BIPAL BIOPSY FORCEPS, THE JAWS OF THE DEVICE WERE UNABLE TO OPEN AND RELEASE FROM THE RIGHT VENTRICLE WHEN ATTEMPTING TO COLLECT A MYOCARDIAL BIOPSY SAMPLE. AS A RESULT, THE PATIENT WAS TAKEN TO SURGERY TO REMOVE THE DEVICE. THIS WAS DURING A MYOCARDIAL BIOPSY PROCEDURE. THERE WERE NO ISSUES OBTAINING VASCULAR ACCESS, AND THE ACCESS VESSEL DID NOT HAVE ANY CALCIFICATION OR TORTUOSITY PRESENT. THE DEVICE WAS STORED, HANDLED, AND PREPPED PE THE INSTRUCTIONS FOR USE (IFU). THE DEVICE WAS REMOVED FROM ITS TRAY IN A HORIZONTAL MOTION AND THERE WAS NEVER AN ATTEMPT TO SHAPE THE TIP OF THE DEVICE. THERE WAS NO DIFFICULTY TRACKING THE DEVICE TOWARDS THE TARGET AREA. THE DEVICE WAS NOT RETUNED AS EXPECTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16526444 ↗
• InjuryDec 28, 2022Difficult to Remove; Difficult to Remove

  ADDITIONAL EVENT DETAILS WERE REQUESTED, INCLUDED A PROCEDURAL CD; HOWEVER, ADDITIONAL INFORMATION COULD NOT BE OBTAINED.

  Patient problems: Internal Organ Perforation

  MAUDE report 16064262 ↗
• MalfunctionAug 29, 2017Difficult to Remove; Difficult to Open or Close; Difficult to Remove; Difficult to Open or Close

  DURING A MYOCARDIA BIOPSY PERFORMED AS PART OF A POST-TRANSPLANT REJECTION ROUTINE SURVEILLANCE EXAM, IT WAS REPORTED THAT THE BIPAL 7F 50CM 2.2MM JAW CLAMP STAYED LOCKED IN A CLOSED POSITION INTO THE RIGHT VENTRICLE, BLOCKING THE CLAMP TO BE REMOVED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6827732 ↗
• MalfunctionFeb 17, 2017Fracture; Fracture

  IT WAS REPORTED THAT THE 7F BIPAL 50CM 2.2MM JAW WAS TWISTED TO 90°. THE PROCEDURE WAS LENGTHENED AND ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT INJURIES. THE KINK OCCURRED DURING THE PROCEDURE. THE PRODUCT WAS NOT KINKED WHEN THE PACKAGED WAS OPENED; IT DID NOT KINK WHILE THE DEVICE WAS BEING REMOVED FROM IT PACKAGE. THERE WAS NO ATTEMPT TO "SHAPE" OR "RE-SHAPE" THE SHAFT OR THE TIP. THE DEVICE WAS REMOVED FROM THE TRAY IN A HORIZONTAL MOTION. IT'S UNKNOWN WHERE THE 90° TWIST TOOK PLACE ON THE DEVICE. A 6F SHEATH WAS USED DURING THE PROCEDURE. AFTER THE DEVICE WAS EVALUATED, THE LINK WITHIN THE CUTTER ASSEMBLY HAD FRACTURED AND CAUSED THE JAWS TO NOT FUNCTION PROPERLY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6339023 ↗