FDA Medical Device Recalls (openFDA)
LeMaitre Vascular, Inc.: 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 number
- Z-2448-2019
- Recalling firm
- LeMaitre Vascular, Inc.
- Product
- 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.
- Status
- Terminated
- Initiated
- 2019-07-24
- Posted
- not on file
- Terminated
- 2020-05-11
- Reason
- incorrect device size being listed on the impacted device packaging
- Root cause
- Labeling mix-ups
- Action
- 1. Quarantine any catalog # 2107-80 devices from lot OLC1051. 2. Complete the enclosed customer reply form and return it to LeMaitre Vascular GmbH by scanning it and emailing it to recalls-emea@lemaitre.com. NOTE: The customer reply form must be returned even if you have no devices at your facility. 3. LeMaitre Vascular GmbH will contact you with information on how to return the product and they will send you replacement devices. For further information about this recall, contact Tobias Malcharczik at tmalcharczik@lemaitre.com.
- Quantity
- 62 units
- Distribution
- GERMANY FRANCE SLOVENIA SPAIN SWEDEN UK
- Lot, serial or model codes
- Lot # OLC1051
- 510(k) numbers
- K132022
- PMA numbers
- not on file
- Product code
- MJN
- Firm FEI
- 1220948
- Firm city
- Burlington
- Firm state
- MA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28