LeMaitre Vascular Recalls Unsealed Polyurethane Carotid Shunts
LeMaitre Vascular is recalling 46 units of Pruitt F3-S Polyurethane Outlying Carotid Shunts because the pouches are not sealed, compromising sterility.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a sterile medical device where the packaging failure compromises sterility, creating a risk of infection or harm, but the source text does not report any specific injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products without reported injury.
Plain-English summary
LeMaitre Vascular, Inc. is recalling 46 units of the Pruitt F3-S Polyurethane Outlying Carotid Shunt, Sterile, Model # 2014-10. The recall is being conducted because the pouches from this specific lot are not sealed, which compromises the sterility of the medical devices.
The affected lot number is PFP1055, with an expiration date of March 28, 2020. The distribution pattern indicates that the products were distributed in Florida and to foreign locations including Australia and Korea.
Healthcare providers and facilities that have received these devices should stop using them and contact LeMaitre Vascular for further instructions on how to return or dispose of the affected units.
The recalled product
- Product
- LeMaitre Vascular Pruitt F3¿-S Polyurethane Outlying Carotid Shunt, Sterile Model # 2014-10
- Manufacturer
- LeMaitre Vascular, Inc.
- Category
- Medical Device — Vascular Shunt
- Affected units
- 46
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- LOT# PFP1055 Expiration Date: 2020-03-28
Distribution
Distributed in 1 state:
Related recalls
Same manufacturer · LeMaitre Vascular, Inc.
See all →- ModerateLeMaitre TufTex Over-the-Wire Embolectomy Catheter Recalled for Balloon Failure
FDA (Devices) · 2026-10-14
- ModerateArtegraft vascular graft recalled over incorrect lot outer packaging labeling
FDA (Devices) · 2026-03-25
- ModerateCollagen vascular graft recalled after being packed in wrong size packaging
FDA (Devices) · 2025-10-29
- ModerateCollagen vascular grafts recalled over incorrect labels missing CE and UKCA marks
FDA (Devices) · 2025-10-15
- ModerateCollagen vascular grafts recalled over unapproved bovine raw material supplier
FDA (Devices) · 2025-10-08
Same hazard · sterility compromise
See all →- ModerateAVID Medical Recalls Halyard IV Start Kits Due to Packaging Seal Issues
FDA (Devices) · 2026-09-30
- HighMedline Recalls Cataract Convenience Kits Due to Open Sterile Seals
FDA (Devices) · 2026-09-23
- HighMedline Myringotomy Kits Recalled for Potential Sterility Compromise
FDA (Devices) · 2026-09-23
- HighMedline Anesthesia Pain Kits Recalled for Potential Sterility Compromise
FDA (Devices) · 2026-09-23
- HighMaquet Percutaneous Insertion Kit Recalled for Sterile Barrier Integrity Issues
FDA (Devices) · 2026-09-23
Similar recalls
- HighPruitt Occlusion Catheter Recalled Due to Incomplete Sterile Barrier Seals
FDA (Devices) · 2025-05-21
- HighPruitt Irrigation Occlusion Catheter Recalled for Incomplete Sterile Seals
FDA (Devices) · 2025-05-21
- ModerateLeMaitre Embolectomy Catheter Recalled for Packaging Sterility Risk
FDA (Devices) · 2015-12-16
- HighLeMaitre Over-the-Wire Embolectomy Catheter Recalled for Packaging Sterility Risk
FDA (Devices) · 2015-12-16
- HighMedtronic Intracoronary Shunts recalled for potential unsealed sterile packaging
FDA (Devices) · 2024-05-22
- ModerateLeMaitre Over-the-Wire Embolectomy Catheter Recalled for Packaging Defect
FDA (Devices) · 2015-12-16