Distal Perfusion Catheter 2105-15Recalls & reported problems
Lemaitre Vascular, Inc. · Distal Perfusion Catheter, 12F · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 9
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00840663101610), received between Dec 28, 2018 and Jan 19, 2024 — classified as 9 malfunctions.
The most frequently reported specific device problem is “Deflation Problem” (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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Deflation Problem3
- Material Rupture3
- Delivered as Unsterile Product1
- Inflation Problem1
- Leak/Splash1
- Positioning Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions5
- No Known Impact Or Consequence To Patient3
- No Patient Involvement1
Recent adverse event reports
The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 19, 2024Material Rupture; Material Rupture
IT WAS REPORTED THAT THE DISTAL PERFUSION CATHETER BALLOON WAS FOUND RUPTURED. NO INJURY WAS REPORTED TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18545981 ↗MalfunctionMar 31, 2023Leak/Splash; Leak/Splash
IT WAS REPORTED THE DISTAL PERFUSION CATHETER HAD BLOOD LEAKED IN THE 3-WAY PART DURING PERFUSION PROCEDURE. NO HARM TO THE PATIENT OCCURRED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16657020 ↗MalfunctionSep 8, 2022Deflation Problem; Inflation Problem; Deflation Problem; Inflation Problem
BALLOON OF THE DISTAL PERFUSION CATHETER DID NOT INFLATE OR DEFLATE PROPERLY DURING THE PRE-TESTING PRIOR TO INSERTING IN THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15380829 ↗MalfunctionMay 14, 2021Material Rupture; Material Rupture
DURING PRE-USE CHECK, WHEN SURGEON ATTEMPTED TO INFLATE THE BALLOON, IT RUPTURED. SO, HE USED ANOTHER CATHETER FOR THE PROCEDURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11828748 ↗MalfunctionMar 19, 2021Material Rupture; Material Rupture
DURING ABDOMINAL ANEURYSM REPAIR, BALLOON OF THE DISTAL PERFUSION CATHETER BURST IN THE MIDDLE OF THE INFLATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11531961 ↗MalfunctionDec 13, 2019Delivered as Unsterile Product; Delivered as Unsterile Product
USER RECEIVED AN UNSEALED TRAY OF A LEMAITRE PERFUSION CATHETER. SHE OBSERVED THE TYVEK LID WAS ALREADY SEPARATED AT THREE SIDES OF THE TRAY WHEN IT WAS REMOVED FROM ITS OUTER PACKAGE. THIS DEVICE DID NOT COME IN CONTACT WITH PATIENT AND WAS NOT USED FOR THE PROCEDURE.
Patient problems: No Patient Involvement
MAUDE report 9469474 ↗MalfunctionJun 19, 2019Deflation Problem; Deflation Problem
DURING PRE-USE CHECK, AFTER SURGEON INFLATED THE BALLOON OF THE DISTAL PERFUSION CATHETER WITH SALINE, HE EXPERIENCED DIFFICULTY DEFLATING THE BALLOON. IT EITHER DEFLATED ONLY PARTIALLY OR TOOK LONGER TIME TO DEFLATE COMPLETELY. THIS MALFUNCTION WAS DETECTED DURING PRE-USE CHECK. SO, THE PATIENT WAS NOT EXPOSED TO THIS CATHETER.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8713437 ↗MalfunctionApr 5, 2019Positioning Problem; Positioning Problem
DURING PRE-USE CHECK, THE BALLOON OF THE DISTAL PERFUSION CATHETER INFLATED NON-CONCENTRIC.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8488700 ↗MalfunctionDec 28, 2018Deflation Problem; Deflation Problem
DURING PRE-USE CHECK, BALLOONS OF THE TWO DISTAL PERFUSION CATHETERS (CATALOG # 2105-15, LOT# DPC1115) FAILED TO DEFLATE COMPLETELY.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8204475 ↗
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- EOPA™ 77622Medtronic, Inc. · Catheter, cannula and tubing, vascular, cardiopulmonary bypass2 recalls4 reports
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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