FDA Enforcement
Class II
Terminated
The LeMaitre Aortic Occlusion Catheter is a single lumen catheter with a latex balloon, it is offered in two balloon sizes: 28 mm or 45mm. The single lumen acts as the inflation lumen for the balloon and is indicated by the white stopcock. Other features include a balloon wall thickness designed to reduce the possibility of puncture by calcium deposits, and a stop-cock to maintain balloon inflation level throughout the procedure.
Recall: Z-2448-2019
·
Reported September 11, 2019
Enforcement
- Recall Number
- Z-2448-2019
- Event ID
- 83535
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- LeMaitre Vascular, Inc.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Visit
- Report Date
- September 11, 2019
- Initiation Date
- July 24, 2019
- Classification Date
- September 3, 2019
- Termination Date
- May 11, 2020
- Address
- 63 2nd Ave, N/A, Burlington, MA, 01803-4413, United States
Description
The LeMaitre Aortic Occlusion Catheter is a single lumen catheter with a latex balloon, it is offered in two balloon sizes: 28 mm or 45mm. The single lumen acts as the inflation lumen for the balloon and is indicated by the white stopcock. Other features include a balloon wall thickness designed to reduce the possibility of puncture by calcium deposits, and a stop-cock to maintain balloon inflation level throughout the procedure.
Reason
incorrect device size being listed on the impacted device packaging
Code Info
Lot # OLC1051
Distribution
GERMANY FRANCE SLOVENIA SPAIN SWEDEN UK
Quantity
62 units