LeMaitre Vascular Pruitt F3-S Shunt: Unsealed Sterile Pouches Risk Infection
LeMaitre Vascular recalls sterile polyurethane carotid shunt model 2014-10 (lot PFP1055) due to unsealed pouches risking infection. Affected units expire March 2020.
Lower-risk recall
Pouches from this lot are not sealed compromising the sterility
Contact the company
What happened, in plain English
LeMaitre Vascular is recalling a specific sterile carotid shunt model because pouches from this batch aren't sealed properly. This could allow infection since the device is meant to be sterile during medical procedures. Read more at govinfonow.com/recall/69712-lemaitre-vascular-pruitt-f3-s-shunt-unsealed-sterile-pouches-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/69712-lemaitre-vascular-pruitt-f3-s-shunt-unsealed-sterile-pouches-risk · Updated August 20, 2026 · FDA enforcement record: FDA #Z-0473-2019
Cite this page
“LeMaitre Vascular Pruitt F3-S Shunt: Unsealed Sterile Pouches Risk Infection.” GovInfoNow, updated August 20, 2026. https://govinfonow.com/recall/69712-lemaitre-vascular-pruitt-f3-s-shunt-unsealed-sterile-pouches-risk. Based on FDA recall #Z-0473-2019 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0473-2019%22&limit=1).
Why it’s dangerous
The pouches aren't sealed properly, which means bacteria could enter the sterile device. This is dangerous because the shunt is used in delicate medical procedures where infection could cause serious complications.
Who’s affected
Patients who received this specific shunt model (2014-10, lot PFP1055) from LeMaitre Vascular. Medical professionals using this model during procedures are at risk if the pouch isn't sealed.
How to tell if you have this one
Check for the model number 2014-10 and lot number PFP1055 on the shunt packaging. The expiration date is March 2020.
- Brand
LeMaitre Vascular- Category
Medical device
What to do — step by step
Check Shunt Packaging
Look for model number 2014-10 and lot number PFP1055 on the shunt packaging.
Where it went and when
Where it was distributed
Distributed in Florida, and outside the U.S.
FDA distribution: “FL Foreign: Austalia, Korea” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: Florida.
Recall timeline
FDA terminated this recall 18 months after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #Z-0473-2019 (October 1, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0473-2019 to see it in context.
- Plain-language summary written by qwen3:4b on August 20, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.