# K022145: Over the Wire Embolectomy Catheter, Model 2302

- Pathway: 510(k) (Traditional)
- Applicant: LeMaitre Vascular, Inc.
- Decided: Jan 14, 2003 after 196 days
- Product code: DXE (Catheter, Embolectomy)
- Device class: 2
- Regulation: 21 CFR 870.5150
- Recalls of this device: 11 (1 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
52 later devices descend from it; 1 cites it directly.
1 of 53 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K040010: Genesis Medical Interventional F.a.S.T. (Facilitated Aspiration/Suction Thrombectomy) Systems (2004), 51 descendants of its own
- K143563: Infusion Aspiration Catheter System (2015), 35 descendants of its own
- K092623: F.a.S.T. System Sed and CXD (2009), 7 descendants of its own
- K163549: ClotTriever Thrombectomy System (2017), 6 descendants of its own
- K162970: FlowTriever Retrieval/Aspiration System, Aspiration Guide Catheter, Retraction Aspirator (2016), 6 descendants of its own

## Recalls of this device
- Aug 28, 2026 · Class II · Z-0117-2027: Devices failed in process testing related to the amount of pull force it can sustain prior to the balloon components failing.
- Apr 11, 2025 · Class II · Z-1750-2025: During internal product testing, it was observed that some packages to have incomplete seals (sterile barrier).
- Mar 23, 2020 · Class I · Z-1567-2020: There has been an increased trend in reports of catheters failing to deflate during use, which may ultimately lead to tip separation.
- Oct 21, 2015 · Class II · Z-0378-2016: Manufacturing issue that could cause a pinhole in the formed end of the packaging, which may lead to compromised sterility.
- Oct 21, 2015 · Class II · Z-0379-2016: Manufacturing issue that could cause a pinhole in the formed end of the packaging, which may lead to compromised sterility.
- Oct 21, 2015 · Class II · Z-0383-2016: Manufacturing issue that could cause a pinhole in the formed end of the packaging, which may lead to compromised sterility.
- Oct 21, 2015 · Class II · Z-0380-2016: Manufacturing issue that could cause a pinhole in the formed end of the packaging, which may lead to compromised sterility.
- Oct 21, 2015 · Class II · Z-0381-2016: Manufacturing issue that could cause a pinhole in the formed end of the packaging, which may lead to compromised sterility.
- Oct 21, 2015 · Class II · Z-0382-2016: Manufacturing issue that could cause a pinhole in the formed end of the packaging, which may lead to compromised sterility.
- Oct 21, 2015 · Class II · Z-0384-2016: Manufacturing issue that could cause a pinhole in the formed end of the packaging, which may lead to compromised sterility.
- Oct 21, 2015 · Class II · Z-0385-2016: Manufacturing issue that could cause a pinhole in the formed end of the packaging, which may lead to compromised sterility.

Source page: https://510kreport.com/device/K022145
Methodology: https://510kreport.com/methodology