Pruitt Occlusion Catheter Recalled Due to Incomplete Sterile Barrier Seals
LeMaitre Vascular is recalling Pruitt Occlusion Catheters (catalog numbers 2103-36, 2103-46, 2103-56, E2103-36, E2103-46, E2103-56) because some packages have incomplete sterile barrier seals, potentially compromising product 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: This is an FDA Class II recall involving a sterile barrier defect on a medical device. The incomplete seals pose a risk of infection or contamination to patients, and no illnesses or injuries are reported in the source text, placing it at the upper end of High severity per the rubric.
Plain-English summary
LeMaitre Vascular, Inc. is recalling Pruitt Occlusion Catheters with catalog numbers 2103-36, 2103-46, 2103-56, E2103-36, E2103-46, and E2103-56. During internal product testing, the manufacturer discovered that some packages had incomplete seals in the sterile barrier.
The affected product has been distributed nationwide in the United States and internationally to 65 countries. The UDI-DI codes are 00840663101535 and 00840663101542. The recall affects units with lot prefixes POC, QPO, and XPO that have not yet expired.
Patients and healthcare providers who have these catheters in stock should stop using affected units immediately. Affected packages can be identified by the catalog numbers and lot prefixes listed above. Contact LeMaitre Vascular, Inc. for instructions on returning or replacing the product.
The recalled product
- Product
- Pruitt Occlusion Catheter. Catalog Numbers: 2103-36, 2103-46, 2103-56, E2103-36, E2103-46, E2103-56
- Manufacturer
- LeMaitre Vascular, Inc.
- Affected units
- 65,977
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 (9)
- UDI-DI: 00840663101535
- 00840663101542. Catalog Numbers: 2103-36
- 2103-46
- 2103-56
- E2103-36
- E2103-46
- E2103-56. Lots not expired with the following prefix: POC
- QPO
- XPO.
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 3 recalled by LeMaitre Vascular, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 3 products in this recall →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 · sterile barrier defect
See all →- HighSurgipro Sutures Recalled for Potential Sterile Barrier Perforation
FDA (Devices) · 2026-08-19
- HighPruitt Irrigation Occlusion Catheter Recalled for Incomplete Sterile Seals
FDA (Devices) · 2025-05-21
- HighB Braun Interventional ELITE HV Hemostasis Valve Introducer System Recall
FDA (Devices) · 2025-05-14
- HighSocrates 38 Aspiration Catheter Recall Due to Sterile Barrier Defect
FDA (Devices) · 2025-03-05
- HighHollister CalciCare Calcium Alginate Dressing Recalled for Packaging Defect
FDA (Devices) · 2024-12-11
Similar recalls
- HighLeMaitre Vascular Recalls Unsealed Polyurethane Carotid Shunts
FDA (Devices) · 2018-11-28
- 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
- ModerateLeMaitre Over-the-Wire Embolectomy Catheter Recalled for Packaging Defect
FDA (Devices) · 2015-12-16
- HighReprocessed electrophysiology catheters recalled over incomplete sterile seals
FDA (Devices) · 2026-05-20
- HighLeMaitre Stent Guide Recalled Due to Compromised Sterility
FDA (Devices) · 2013-04-10