Carpentier 58729Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 20643169490110), received between May 21, 2019 and Jul 24, 2023 — classified as 1 injury, 6 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (3 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 24, 2023Material Deformation; Material Deformation

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO THE USE OF THREE CARPENTIER BI-CAVAL FEMORAL VENOUS CANNULAE, THE CUSTOMER REPORTED A BEND IN THE MIDDLE PART OF THE CANNULA. THE DEVICE WAS NOT USED. THERE WAS NO PATIENT INVOLVEMENT SO NO ADVERSE EFFECT OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17378537 ↗
• MalfunctionJul 24, 2023Material Deformation; Material Deformation

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO THE USE OF THREE CARPENTIER BI-CAVAL FEMORAL VENOUS CANNULAE, THE CUSTOMER REPORTED A BEND IN THE MIDDLE PART OF THE CANNULA. THE DEVICE WAS NOT USED. THERE WAS NO PATIENT INVOLVEMENT SO NO ADVERSE EFFECT OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17378233 ↗
• MalfunctionJul 24, 2023Material Deformation; Material Deformation

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO THE USE OF THREE CARPENTIER BI-CAVAL FEMORAL VENOUS CANNULAE, THE CUSTOMER REPORTED A BEND IN THE MIDDLE PART OF THE CANNULA. THE DEVICE WAS NOT USED. THERE WAS NO PATIENT INVOLVEMENT SO NO ADVERSE EFFECT OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17377487 ↗
• MalfunctionJun 24, 2022Crack; Mechanical Problem; Material Puncture/Hole; Crack; Mechanical Problem; Material Puncture/Hole

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF A CARPENTIER BI-CAVAL FEMORAL VENOUS CANNULA, THE CUSTOMER REPORTED THAT AT THE END OF THE OPERATION, THE CANNULA TUBE BROKE DURING THE REMOVAL PROCESS. THE DEVICE WAS REPLACED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT IMPACT ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14798036 ↗
• MalfunctionJun 22, 2022Material Puncture/Hole; Material Puncture/Hole

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF A CARPENTIER BI-CAVAL FEMORAL VENOUS CANNULA THE CUSTOMER REPORTED THAT, DURING THORACOSCOPIC SURGERY, THE PATIENT'S SYSTEMIC CIRCULATION FLOW WAS UNSTABLE. IT WAS REPORTED THAT THE CANNULA BODY WAS BROKEN WHEN THE CUSTOMER WAS ADJUSTING THE CANNULA. THE MEDTRONIC REP WAS NOTIFIED TO SOLVE THE PROBLEM. THE SALES TEAM FOUND THAT THE DRAINAGE PORT OF THE LOWER CAVITY OF THE CANNULA WAS OBVIOUSLY BROKEN. THE DEVICE WAS REPLACED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT IMPACT ASSOCIATED WITH THIS EVENT.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; No Clinical Signs, Symptoms or Conditions

  MAUDE report 14775246 ↗
• MalfunctionJun 13, 2022Material Puncture/Hole; Material Puncture/Hole

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF A CARPENTIER BI-CAVAL FEMORAL VENOUS CANNULA, IT WAS REPORTED THAT DURING A THORACOSCOPIC SURGERY, THE CUSTOMER ADJUSTED THE INSERTION DEPTH DURING THE OPERATION. THE CUSTOMER OBSERVED THAT THE TUBE BODY HAD BROKEN DURING THE OPERATION. THE SALES REP WENT TO SUPPORT THE CUSTOMER AND CHECKED THE ON-SITE INTUBATION, AND OBSERVED THAT THE DRAINAGE PORT IN THE LOWER CAVITY OF THE TUBE WAS OBVIOUSLY BROKEN. THE DEVICE WAS REPLACED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT IMPACT ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14673946 ↗
• InjuryMay 21, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE, THE CUSTOMER REPORTED THAT VENOUS DRAINAGE WAS NOT EFFECTIVE WHILE USING THE CARPENTIER BI-CAVAL FEMORAL VENOUS CANNULA. THE END OF THE CANNULA WAS FOUND TO BE BROKEN WHEN THE VENOUS CANNULA WAS REMOVED. SEE THE ATTACHED IMAGE. THE FRACTURE OCCURRED AFTER THE OPERATION WHEN THE CANNULA WAS REMOVED FROM THE PATIENT. THE CANNULA WAS PART OF AN INTEGRATED INTUBATION DESIGN AND WAS REMOVED FROM THE PATIENT'S FEMORAL VEIN USING THE NORMAL REMOVAL PROCEDURE. THE CANNULA ISSUE RESULTED IN POOR DRAINING, AFFECTING INTRAOPERATIVE EXTRACORPOREAL FLOW, AFFECTING THE PATIENT'S INTRAOPERATIVE OXYGEN SUPPLY. THE CUSTOMER STATED THAT WHEN THE CANNULA WAS USED THE THREAD RING WAS NOT TAKEN WITH A SURGICAL FORCEPS.

  Patient problems: Ischemia

  MAUDE report 8627649 ↗