Pruitt Irrigation Occlusion Catheter 2102-09Recalls & reported problems
Lemaitre Vascular, Inc. · Pruitt Irrigation Occlusion Catheter, 9F · Class 2
All models of Pruitt Irrigation Occlusion Catheter (2)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00840663101535), received between Oct 29, 2021 and Feb 27, 2024 — classified as 4 malfunctions.
The most frequently reported specific device problem is “Failure to Deflate” (2 reports).
1 FDA recall record name this device's identifier, 1 still open.
1 other recall cover devices cleared under the same FDA submission (K880231); 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.
Reports received per month
Recalls naming this device
- Apr 11, 2025Class IIOpen, Classified
During internal product testing, it was observed that some packages to have incomplete seals (sterile barrier).
Z-1751-2025 · Root cause: Packaging process control · Recall details · FDA record ↗
Most reported problems
Device problems
- Failure to Deflate2
- Material Rupture2
Patient problems
- No Clinical Signs, Symptoms or Conditions4
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 27, 2024Material Rupture; Material Rupture
IT WAS REPORTED THAT THE PRUITT IRRIGATION OCCLUSION CATHETER BALLOON RUPTURED WHILE ATTEMPTING TO USE IT TO OCCLUDE VESSEL. IT DID NOT HOLD FLUID TO OCCLUDE VESSEL, EVEN ON FIRST PASS. IT WAS UNSURE IF THE PRODUCT WAS TESTED PRIOR TO USE. NO INJURY WAS REPORTED TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18790728 ↗MalfunctionJul 20, 2023Failure to Deflate; Failure to Deflate
IT WAS REPORTED THE PRUITT IRRIGATION OCCLUSION CATHETER BALLOON DIDN'T DEFLATE. NO INJURY REPORTED TO PATIENT AS THE DEVICE WAS NOT DIRECTLY USED ON THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17362430 ↗MalfunctionApr 14, 2023Failure to Deflate; Failure to Deflate
IT WAS REPORTED THAT THE PRUITT IRRIGATION OCCLUSION CATHETER BALLOON FAILED TO DEFLATE DURING THE PRE-USE CHECK. THE DEVICE WAS NOT USED FOR THE PROCEDURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16742964 ↗MalfunctionOct 29, 2021Material Rupture; Material Rupture
THE CATHETER WAS USED DURING THE REPLACEMENT OF THE ARTIFICIAL BLOOD VESSEL IN THE THORACOABDOMINAL REGION. THE BALLOON OF THE CATHETER RUPTURED DURING THE OPERATION. THE PHYSICIAN REPLACED THAT CATHETER WITH ANOTHER PRUITT IRRIGATION OCCLUSION CATHETER AND CONTINUED THE OPERATION. THERE WAS NO IMPACT ON THE PATIENT BECAUSE OF THE CATHETER MALFUNCTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12719744 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K880231. One submission often covers many models, so check the product and lot details in each record.
- Z-1752-2025 · Apr 11, 2025 · Open, ClassifiedPruitt Irrigation Occlusion Catheter. Catalog Numbers: 2102-09, E2102-09.
Other Occluder, Catheter Tip devices
- Pruitt Irrigation Occlusion Catheter e2102-09Lemaitre Vascular, Inc. · Occluder, Catheter Tip1 recall0 reports
- Pruitt Aortic Occlusion Catheter 2100-12Lemaitre Vascular, Inc. · Occluder, Catheter Tip6 reports
- Polyurethane Dual Lumen Occlusion Catheter 5F-2L-40Lemaitre Vascular, Inc. · Occluder, Catheter Tip1 report
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 · each recall links to the FDA recall notice
- 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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