HYDRO LeMaitre Valvulotome 1009-00Recalls & reported problems

Summary

The FDA's MAUDE database contains 71 adverse event reports that list this exact device (DI 00840663106653), received between Dec 1, 2016 and Mar 30, 2026 — classified as 8 injuries, 63 malfunctions.

The most frequently reported specific device problem is “Difficult to Open or Close” (26 reports).

3 other recalls cover devices cleared under the same FDA submission (K140042); they may or may not involve this specific model.

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 25 most recent of 71 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 30, 2026Retraction Problem

  IT WAS REPORTED THAT THE LEMAITRE VALVULOTOME HAD BEEN USED TWICE, AND UPON REMOVAL FROM THE BODY, IT WAS OBSERVED THAT THE BLADE WOULD NOT RETRACT INTO THE SHEATH. NO ADDITIONAL COMPLICATIONS OR PATIENT INJURY WERE REPORTED. IT IS UNKNOWN IF THE DEVICE WAS CHECKED PRIOR TO USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24711949 ↗
• MalfunctionFeb 27, 2026Retraction Problem

  IT WAS REPORTED THAT UPON OPENING THE PACKAGE, THE SHEATH DID NOT FULLY RETRACT, LEAVING THE BLADE EXPOSED. THE DEVICE WAS NOT USED ON A PATIENT. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24468687 ↗
• MalfunctionFeb 24, 2025Retraction Problem; Retraction Problem

  IT WAS REPORTED THAT THE VALVULOTOME TIP WAS OBSERVED TO BE BENT IN THE CLOSED POSITION AND ONE OF THE BLADES WAS STICKING OUT DURING A FEM-TIB BYPASS PROCEDURE. THE DEVICE COULDN'T BE USED PROPERLY. THE DEVICE WAS IN DIRECT USE WITH THE PATIENT. SURGEON ENDED UP USING EPTFE GRAFT. NO INJURY WAS REPORTED TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21455130 ↗
• MalfunctionJan 24, 2025Retraction Problem; Retraction Problem

  IT WAS REPORTED THAT THE LEMAITRE VALVULOTOME WOULD NOT CLOSE AT THE DISTAL END OF THE PATIENT'S VEIN DURING A IN SITU BYPASS PROCEDURE. THE SURGEON PULLED THE VALVULOTOME OUT WITHOUT CLOSING AND TORE THE END OF THE VEIN. THERE WAS ENOUGH LENGTH THAT THE TORN PORTION COULD BE CUT OFF. ISSUE WAS DEALT WITH BY CAREFULLY REMOVING THE PRODUCT WITH NO ISSUES. THE PATIENT IS DOING FINE WITH NO REPORTED INJURY.

  Patient problems: Vascular Dissection

  MAUDE report 21230184 ↗
• MalfunctionJan 12, 2024Retraction Problem; Retraction Problem

  IT WAS REPORTED THAT THE LEMAITRE VALVULOTOME HAS A BROKEN BLADE THAT WILL NOT RETRACT OUT OF THE BOX. THE ISSUE WAS FOUND DURING TESTING. IT WAS NOT USED ON A PATIENT. NO INJURY WAS REPORTED TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18502134 ↗
• MalfunctionOct 3, 2023Retraction Problem; Retraction Problem

  IT WAS REPORTED THE BLADE DOES NOT CLOSE PROPERLY WHEN SHEATHING. THE ISSUE WAS FOUND DURING A PRE-USE CHECK AND WAS NOT USED ON A PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17863197 ↗
• MalfunctionSep 29, 2023Sharp Edges; Sharp Edges

  IT WAS REPORTED DURING PRE-USE CHECK, IT WAS NOTICED THE SURFACE OF THE PROTECTIVE SHEATH WAS NOT UNIFORM. THEY WERE CONCERNED WITH INSERTING IT INTO THE SAPHENOUS VEIN WOULD CAUSE DAMAGE, THEREFORE THE DEVICE WAS NOT USED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17843392 ↗
• MalfunctionAug 31, 2023Retraction Problem; Retraction Problem

  IT WAS REPORTED THE LEMAITRE VALVULOTOME DID NOT SHEATH PROPERLY AFTER FIRST PASS DURING INSITU BYPASS- FEM-TIB PROCEDURE. A NEW VALVULOTOME WAS OPENED AND USED FOR THE 2ND PASS. NO INJURY WAS REPORTED TO PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17664584 ↗
• MalfunctionAug 15, 2023Retraction Problem; Retraction Problem

  IT WAS REPORTED THE LEMAITRE VALVULOTOME WOULD NOT CLOSE. THE USER HAD TO PUSH THE HOOPS TOGETHER AGAIN. NO INJURY WAS REPORTED TO PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17553661 ↗
• MalfunctionJul 21, 2023Retraction Problem; Retraction Problem

  IT WAS REPORTED THAT THE LEMAITRE VALVULOTOME DID NOT CLOSE PROPERLY. NO INJURY WAS REPORTED TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17371154 ↗
• InjuryJul 13, 2023Retraction Problem; Retraction Problem

  IT WAS REPORTED LEMAITRE VALVULOTOME DID NOT RESHEATH AT FINAL STEP OF WITHDRAWAL DURING LEG REVASCULARIZATION PROCEDURE. UPON WITHDRAW 2CM OF VEIN WAS INJURED REQUIRING THAT SECTION TO BE EXCISED FOLLOWED BY A SPLICE GRAFT. THE FINAL WITHDRAW WAS PARTIALLY EXPOSED. PATIENT HAD PROLONGED STAY AT HOSPITAL.

  Patient problems: Perforation of Vessels

  MAUDE report 17316643 ↗
• InjuryJul 12, 2023Retraction Problem; Retraction Problem

  IT WAS REPORTED LEMAITRE VALVULOTOME HAD RESISTANCE WHEN INSERTED AND READY TO DEPLOY DURING FEM-TIB BYPASS PROCEDURE RESULTING IN TEAR OF VEIN. THE SURGERY WAS PROLONGED FOR 5 HOURS AND PATIENT HAD EXTENDED STAY IN HOSPITAL. A SECOND VALVULOTOME WAS USED TO RESOLVE THE ISSUE.

  Patient problems: Perforation of Vessels

  MAUDE report 17309177 ↗
• InjuryJun 22, 2023Retraction Problem; Retraction Problem

  IT WAS REPORTED LEMAITRE VALVULOTOME CUT THROUGH THE VEIN IN TWO DIFFERENT SPOTS AFTER 2 PASSES DURING IN-SITU BYPASS SURGERY.

  Patient problems: Perforation of Vessels

  MAUDE report 17181556 ↗
• MalfunctionJun 7, 2023Retraction Problem; Retraction Problem

  IT WAS REPORTED VALVULOTOME WOULD NOT RE-SHEATH/RETRACT FOR REMOVAL. ON THE THIRD ATTEMPT IT DID RE-SHEATH ENOUGH TO WITHDRAW WITHOUT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17078638 ↗
• MalfunctionMay 9, 2023Difficult to Open or Close; Difficult to Open or Close

  THE LEMAITRE VALVULOTOME COULD NO LONGER BE CLOSED. IT WAS REPORTED METAL THREADS ARE VISIBLE ON THE HEAD. THE BLADES BECAME UNABLE TO CLOSE. NO INJURY REPORTED TO THE PATIENT. THE PATIENT IS DOING FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16898949 ↗
• MalfunctionApr 20, 2023Difficult to Open or Close; Difficult to Open or Close

  IT WAS REPORTED THAT THE LEMAITRE VALVULOTOME BLADES COULD NO LONGER BE CLOSED. NO INJURY WAS REPORTED. THE USER MENTIONED THAT THEY HAD A SIMILAR INCIDENT OCCUR IN JANUARY AS WELL. PLEASE NOTE THAT REPORT 1220948-2023-00070 WAS ALSO SUBMITTED FOR THE REPORT OF A SIMILAR INCIDENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16779324 ↗
• MalfunctionApr 13, 2023Retraction Problem; Retraction Problem

  WHILE TESTING THE LEMAITRE VALVULOTOME DEVICE DURING THE PRE-USE CHECK THE BLADES WERE OPENED AND CLOSED. ONE OF THE BLADES DID NOT CLOSE AND REMAINED EXPOSED DURING THE TEST. THE DEVICE WAS NOT USED ON THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16731919 ↗
• MalfunctionDec 28, 2022Retraction Problem; Retraction Problem

  IT WAS REPORTED THAT THE BLADES ON THE LEMAITRE VALVULOTOME DID NOT RETRACT ALL THE WAY BACK INTO THE SLEEVE. THE USER MANUALLY PUSHED THE BLADES IN AND AFTER THEY HAD NO OTHER ISSUES USING THE DEVICE. THERE WAS NO INJURY REPORTED FOR THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16062660 ↗
• MalfunctionDec 21, 2022Retraction Problem; Retraction Problem

  IT WAS REPORTED THAT THE BLADES ON THE LEMAITRE VALVULOTOME CUT THE VEIN UP INSIDE. THE PATIENT WAS DOING FINE AFTER THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16023780 ↗
• MalfunctionDec 8, 2022Material Twisted/Bent; Material Twisted/Bent

  PATIENT CONDITION PRIOR TO SURGERY WAS LISTED AS "CRITICAL LIMB ISCHEMIA OF RIGHT LOWER EXTREMITY WITH GANGRENE". THE CASE STARTED WITH AN ANGIOGRAM OF THE RIGHT LOWER EXTREMITY AND THEN PROGRESSED TO A FEMORAL-TIBIAL BYPASS GRAFTING USING VEIN HARVESTED FROM THE IPSILATERAL SIDE. DR. GILBERTSON USED THE VALVULOTOME ONCE TO CUT VALVES WITHIN THE HARVESTED VEIN GRAFT. LATER IN THE CASE THE VALVULOTOME WAS NEEDED AGAIN BUT BEFORE ATTEMPTING TO INSERT IT INTO THE VEIN GRAFT SURGICAL STAFF DISCOVERED THAT THE BLADE HAD DETACHED FROM THE TIP OF THE DEVICE AND WAS BENT SLIGHTLY. NO INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15940257 ↗
• MalfunctionDec 2, 2022Retraction Problem; Retraction Problem

  IT WAS REPORTED THAT THE BLADES ON THE LEMAITRE VALVULOTOME DID NOT RETRACT ALL THE WAY BACK INTO THE SLEEVE. THERE WAS NO INJURY REPORTED FOR THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15909887 ↗
• MalfunctionNov 4, 2022Retraction Problem; Retraction Problem

  IT WAS REPORTED THAT A LEMAITRE VALVULOTOME WAS DEFECTIVE WHEN REMOVED FROM THE STERILE PACKAGING. THE ANTERIOR CONE COULD NOT BE COMPLETELY PULLED INTO THE SHAFT AND A KNIFE BLADE PROTRUDED INTO THE VASCULAR LUMEN. THERE WAS NO INJURY REPORTED FOR THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15735329 ↗
• MalfunctionSep 29, 2022Retraction Problem; Material Deformation; Retraction Problem; Material Deformation

  A REPORT WAS RECEIVED FROM THE CANADA VIGILANCE PROGRAM REGARDING AN INCIDENT WHERE A LEMAITRE VALVULOTOME DEVICE HAD THE BLADE BROKEN, EXPOSED AND DEFORMED. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15505612 ↗
• MalfunctionSep 29, 2022Retraction Problem; Material Deformation; Retraction Problem; Material Deformation

  A REPORT WAS RECEIVED FROM THE CANADA VIGILANCE PROGRAM REGARDING AN INCIDENT WHERE A LEMAITRE VALVULOTOME DEVICE HAD THE LINES TO THE BLADES REMAINED EXPOSED WHILE THE DEVICE WAS PULLED CLOSED, THE SURGEON FELT RESISTANCE AND CAUSED TRAUMA TO THE INTIMA.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15505425 ↗
• MalfunctionSep 1, 2022Retraction Problem; Retraction Problem

  ACCORDING TO THE SURGEON, A PATIENT WITH CRITICAL LIMB ISCHEMIA WAS INDICATED FOR FEMOROPOPLITEAL VENOUS IN SITU BYPASS AND DISOBLITERATION. BEFORE USING THE VALVULOTOME A STANDARD PREPARATION WAS PERFORMED - RINSING AND REPEATED TEST OF THE FUNCTIONALITY OF THE VALVULOTOME BY THE OPERATOR. THE SAPH. MAGNA VEIN WAS OF BORDERLINE WIDTH, BUT USABLE FOR IN SITU BYPASS. THE VALVULOTOME WAS INTRODUCED FROM THE DISTAL END OF THE VEIN GRAFT PROXIMALLY IN THE CLOSED POSITION TO THE PROXIMAL END OF THE GRAFT. BEFORE SEWING THE PROXIMAL ANASTOMOSIS, THE SURGEON NEEDED TO SLIGHTLY PULL BACK THE VALVULOTOME, IT WAS STILL IN A CLOSED POSITION. HOWEVER, WHEN MOVING BACKWARD, THE CATHETER WAS IMMEDIATELY BLOCKED. DURING THE OPEN REVISION OF THE BLOCKED CATHETER, THE SURGEON FOUND THAT THERE WAS A LONGITUDINAL LACERATION OF THE VEIN GRAFT WITH A LENGTH OF 10 CM. THE CAUSE WAS THE ECCENTRIC PROTRUSION OF 1 VALVULOTOME KNIFE, WHICH CAUSED LACERATION OF THE GRAFT. THE VALVULOTOME WAS STILL IN THE CLOSED POSITION. THE DAMAGE OF THE VEIN GRAFT WAS SO EXTENSIVE THAT IT COULD NOT BE USED FOR THE BYPASS. A DIFFERENT GRAFT WAS USED TO COMPLETE THE OPERATION.

  Patient problems: Laceration(s)

  MAUDE report 15340769 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K140042. One submission often covers many models, so check the product and lot details in each record.

• Z-2543-2016 · Aug 3, 2016 · Terminated
  1.5 mm HYDRO LeMaitre Valvulotome, 98 cm, Sterile REF # 1009-00 Product Usage: The HYDRO LeMaitre Valvulotome is intended for the treatment of vascular disorders and more particu
• Z-2545-2016 · Aug 3, 2016 · Terminated
  1.5 mm HYDRO LeMaitre Valvulotome, 40 cm. Sterile REF # 1010-00 Product Usage: The HYDRO LeMaitre Valvulotome is intended for the treatment of vascular disorders and more particul
• Z-2544-2016 · Aug 3, 2016 · Terminated
  1.5 mm HYDRO LeMaitre Valvulotome without LeMills, 98 cm. Sterile REF# 1009-00J Product Usage: The HYDRO LeMaitre Valvulotome is intended for the treatment of vascular disorders a