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Pruitt Irrigation Occlusion Catheter
Lemaitre Vascular, Inc. · Model 2102-09 · UDI-DI 00840663101535
DQT
Prescription
1
510(k) clearances
153
Adverse events (9 deaths)
4
Recalls
5
Facilities
Description
Pruitt Irrigation Occlusion Catheter, 9F
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2025-04-11 | LeMaitre Vascular, Inc. | During internal product testing, it was observed that some packages to have incomplete seals (sterile barrier). |
| 2013-10-21 | Medtronic Vascular | Potential for PTFE (polytetrafluroethylene) coating to delaminate and detach from Guidewire. |
| 2013-10-21 | Medtronic Vascular | Potential for PTFE (polytetrafluroethylene) coating to delaminate and detach from Guidewire. |
| 2005-05-17 | LeMaitre Vascular, Inc. | LeMaitre Vascular is recalling certain lots of its Pruitt Aortic Occlusion Catheters due to a packaging defect which could compromise product sterility. |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.