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.
Reported: September 11, 2019 Initiated: July 24, 2019 #Z-2448-2019
Product 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 for Recall
incorrect device size being listed on the impacted device packaging
Details
- Recalling Firm
- LeMaitre Vascular, Inc.
- Units Affected
- 62 units
- Distribution
- GERMANY FRANCE SLOVENIA SPAIN SWEDEN UK
- Location
- Burlington, MA
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by LeMaitre Vascular, Inc.. Units affected: 62 units.
Why was this product recalled? ▼
incorrect device size being listed on the impacted device packaging
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on September 11, 2019. Severity: Moderate. Recall number: Z-2448-2019.
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