LeMaitre Aortic Occlusion Catheter 2107-81Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00840663101658), received between Nov 22, 2019 and Jul 1, 2021 — classified as 1 injury, 9 malfunctions.

The most frequently reported specific device problem is “Material Puncture/Hole” (7 reports).

1 other recall cover devices cleared under the same FDA submission (K132022); 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 1, 2021Material Puncture/Hole; Material Puncture/Hole

  DURING PRE-CHECK, WHEN THE USER INFLATED THE BALLOON OF THE LEMAITRE AORTIC OCCLUSION CATHETER WITH LIQUID, HE OBSERVED A LEAKAGE FROM THE BALLOON.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12099627 ↗
• MalfunctionMar 10, 2021Material Puncture/Hole; Material Puncture/Hole

  DURING PRE-CHECK, WHEN USER INFLATED THE BALLOON OF THE LEMAITRE AORTIC OCCLUSION CATHETER WITH LIQUID, HE OBSERVED A LEAKAGE FROM THE BALLOON. THIS IS REPORT 1 OF 2.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11457081 ↗
• MalfunctionMar 10, 2021Material Puncture/Hole; Material Puncture/Hole

  DURING PRE-CHECK, THE BALLOON OF THE LEMAITRE AORTIC OCCLUSION CATHETER RUPTURED UPON INFLATION. THIS IS REPORT 2 OF 2.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11457079 ↗
• MalfunctionFeb 24, 2021Material Puncture/Hole; Material Puncture/Hole

  DURING PRE-CHECK, WHEN USER INFLATED THE BALLOON OF THE LEMAITRE AORTIC OCCLUSION CATHETER WITH LIQUID, HE OBSERVED A LEAKAGE FROM THE BALLOON. THIS IS REPORT 2 OF 2.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11375794 ↗
• MalfunctionFeb 24, 2021Material Puncture/Hole; Material Puncture/Hole

  DURING PRE-CHECK, WHEN USER INFLATED THE BALLOON OF THE LEMAITRE AORTIC OCCLUSION CATHETER WITH LIQUID, HE OBSERVED A LEAKAGE FROM THE BALLOON. THIS IS REPORT 1 OF 2.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11375764 ↗
• MalfunctionFeb 19, 2021Material Rupture; Material Rupture

  SURGEON USED LEMAITRE AORTIC OCCLUSION CATHETER (REF# 2107-81 LOT# OLC1059) ON A DECEASED PATIENT DURING ORGAN EXPLANT. HOWEVER, THE BALLOON OF THIS CATHETER DEFLATED DURING THE PROCEDURE. DESPITE THE MALFUNCTION, SURGEON WAS ABLE TO REMOVE THE ORGAN SUCCESSFULLY AND JUST IN TIME AND AS HE WAS ABLE TO COMPLETE THE ENTIRE PROCEDURE IN LESS THAN 25 MINUTES. THIS IS REPORT 2 OF 2.

  Patient problems: Insufficient Information

  MAUDE report 11352882 ↗
• MalfunctionFeb 19, 2021Material Rupture; Material Rupture

  SURGEON USED LEMAITRE AORTIC OCCLUSION CATHETER (REF# 2107-81 LOT# OLC1059) ON A DECEASED PATIENT DURING ORGAN EXPLANT. HOWEVER, THE BALLOON OF THIS CATHETER BURST UPON INFLATION. DESPITE THE MALFUNCTION, SURGEON WAS ABLE TO REMOVE THE ORGAN SUCCESSFULLY AND JUST IN TIME AND AS HE WAS ABLE TO COMPLETE THE ENTIRE PROCEDURE IN LESS THAN 25 MINUTES. THIS IS REPORT 1 OF 2.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11352783 ↗
• InjuryDec 20, 2019Burst Container or Vessel; Burst Container or Vessel

  A (B)(6) CADAVER WAS PUT INTO ECMO WITH NONMOTHERMIC REPERFUSION IN ORDER TO REMOVE THE LIVER, KIDNEY AND PANCREAS FOR TRANSPLANT. THE AORTIC BALLOON WAS CHANNELED THROUGH THE LEFT FEMORAL ARTERY AND WAS INFLATED TO 30 CC WITH 0.9% SALINE. RADIAL BLOOD PRESSURE DROP WAS VERIFIED CONFIRMING THE CATHETER WAS FUNCTIONING PROPERLY. DURING THE PROCEDURE, ECMO STOPPED AND IT WENT TO AN ASYSTOLE IN LESS THAT 2 MINUTES. TRANSPLANT COORDINATOR THEN INFUSED SALINE TO A MAXIMUM DOSE OF 50 CC WITHOUT EXPERIENCING ANY RESISTANCE. ECMO WAS ACTIVATED AGAIN AND RESUMES SELF-RESUSCITATION. HOWEVER, ECMO STOPPED AGAIN. SO, THE PROCEDURE WAS SUSPENDED AND THE BALLOON WAS REMOVED FROM THE PATIENT'S VESSEL. HE OBSERVED THAT THE BALLOON OF THIS CATHETER HAD RUPTURED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9504109 ↗
• MalfunctionNov 22, 2019Material Puncture/Hole; Material Puncture/Hole

  DURING PRE-USE CHECK, WHEN SURGEON ATTEMPTED TO INFLATE THE BALLOON OF THE LEMAITRE AORTIC OCCLUSION CATHETER TO TEST BALLOON FUNCTIONALITY, HE OBSERVED THE BALLOON WAS ALREADY PUNCTURED. DEVICE WAS NOT USED FOR THE PROCEDURE. THIS IS REPORT 2 OF 2.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9365851 ↗
• MalfunctionNov 22, 2019Material Puncture/Hole; Material Puncture/Hole

  DURING PRE-USE CHECK, WHEN SURGEON ATTEMPTED TO INFLATE THE BALLOON OF THE LEMAITRE AORTIC OCCLUSION CATHETER TO TEST BALLOON FUNCTIONALITY, HE OBSERVED THE BALLOON WAS ALREADY PUNCTURED. DEVICE WAS NOT USED FOR THE PROCEDURE. THIS IS REPORT 1 OF 2.

  Patient problems: No Patient Involvement

  MAUDE report 9365844 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K132022. One submission often covers many models, so check the product and lot details in each record.

• Z-2448-2019 · Jul 24, 2019 · Terminated
  The LeMaitre Aortic Occlusion Catheter is a single lumen catheter with a latex balloon, it is offered in two balloon sizes: 28 mm or 45mm. The single lumen acts as the inflation lu