Pruitt Occlusion CatheterRecalls & reported problems across all models
Lemaitre Vascular, Inc. · 6 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
1 open recall names at least one Pruitt Occlusion Catheter model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 5
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls
- 1
We found 6 models of Pruitt Occlusion Catheter by Lemaitre Vascular, Inc. in the FDA's device registry (GUDID). Together they are named in 5 adverse event reports in the FDA's MAUDE database, received between Jul 14, 2022 and Mar 8, 2024 — classified as 5 malfunctions.
The most frequently reported specific device problem is “Material Rupture” (5 reports).
1 FDA recall record name at least one of these models by its device identifier, 1 still open.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Pruitt Occlusion Catheter recalls
FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.
- Apr 11, 2025Open, Classified
During internal product testing, it was observed that some packages to have incomplete seals (sterile barrier).
Z-1752-2025 · Root cause: Packaging process control · names 6 of these models · Recall details · FDA record ↗
Most reported Pruitt Occlusion Catheter problems
Device problems
- Material Rupture5
Patient problems
- No Clinical Signs, Symptoms or Conditions5
Pruitt Occlusion Catheter models
6 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Pruitt Occlusion Catheter 2103-36Catheter, Flow Directed1 recall4 reports
- Pruitt Occlusion Catheter 2103-56Catheter, Flow Directed1 recall1 report
- Pruitt Occlusion Catheter 2103-46Catheter, Flow Directed1 recall0 reports
- Pruitt Occlusion Catheter e2103-36Catheter, Flow Directed1 recall0 reports
- Pruitt Occlusion Catheter e2103-46Catheter, Flow Directed1 recall0 reports
- Pruitt Occlusion Catheter e2103-56Catheter, Flow Directed1 recall0 reports
Recent Pruitt Occlusion Catheter adverse event reports
The 5 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionMar 8, 2024Material Rupture; Material Rupture
THE PRUITT OCCLUSION CATHETER (POC) AND XENOSURE WERE USED IN ONE CASE OF ENDARTERECTOMY + EVT. AFTER ENDARTERECTOMY OF THE RIGHT FEMORAL ARTERY AND PLACEMENT OF A METAL STENT, THE SHAFT OF THE POC WAS INSERTED INTO THE VESSEL TO PLACE A PATCH AT THE ENDARTERECTOMY SITE. HOWEVER, THE BALLOON OF THE POC RUPTURED, SO THE BLOOD FLOW COULD NOT BE BLOCKED. SINCE THE STENT WAS PLACED ON THE PROXIMAL SIDE OF THE ENDARTERECTOMY SITE, IT WAS NOT POSSIBLE TO OCCLUDE THE BLOOD VESSEL USING VASCULAR CLAMP. SO, PTA BALLOON WAS USED INSTEAD TO OCCLUDE THE BLOOD FLOW. THE XENOSURE PATCH WAS SUTURED TO THE ENDARTERECTOMY SITE AND THE SURGERY WAS COMPLETED. THE PATIENT IS DOING WELL AND THERE WERE NO HEALTH COMPLICATIONS. THE CAUSE OF THE BALLOON RUPTURE APPEARS TO BE CONTACT WITH THE METAL PART OF THE STENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18865689 ↗MalfunctionJul 14, 2022Material Rupture; Material Rupture
THE BALLOONS OF THE FOUR PRUITT OCCLUSION CATHETERS RUPTURED DURING A TEA PROCEDURE IN A PATIENT. THERE WAS NO HARM TO THE PATIENT BECAUSE OF THIS INCIDENT. THIS IS REPORT 4 OF 4.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15013585 ↗MalfunctionJul 14, 2022Material Rupture; Material Rupture
THE BALLOONS OF THE FOUR PRUITT OCCLUSION CATHETERS RUPTURED DURING A TEA PROCEDURE IN A PATIENT. THERE WAS NO HARM TO THE PATIENT BECAUSE OF THIS INCIDENT. THIS IS REPORT 2 OF 4.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15013584 ↗MalfunctionJul 14, 2022Material Rupture; Material Rupture
THE BALLOONS OF THE FOUR PRUITT OCCLUSION CATHETERS RUPTURED DURING A TEA PROCEDURE IN A PATIENT. THERE WAS NO HARM TO THE PATIENT BECAUSE OF THIS INCIDENT. THIS IS REPORT 3 OF 4.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15013580 ↗MalfunctionJul 14, 2022Material Rupture; Material Rupture
THE BALLOONS OF THE FOUR PRUITT OCCLUSION CATHETERS RUPTURED DURING A TEA PROCEDURE IN A PATIENT. THERE WAS NO HARM TO THE PATIENT BECAUSE OF THIS INCIDENT. THIS IS REPORT 1 OF 4.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15013578 ↗
Other Lemaitre Vascular, Inc. products
- LeMaitre Embolectomy Catheter47 models · 438 reports · 2 recalls
- Pruitt F3 Carotid Shunt10 models · 305 reports
- Artegraft Vascular Graft15 models · 25 reports · 3 recalls
- Trivex System3 models · 69 reports
- Syntel Silicone OTW Embolectomy Catheter8 models · 66 reports
- Syntel Silicone Thrombectomy Catheter5 models · 6 reports · 1 recall
- Pruitt Irrigation Occlusion Catheter2 models · 4 reports · 1 recall
- LifeSpan ePTFE Vascular Graft10 models · 27 reports
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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