FDA Medical Device Recalls (openFDA)
Ascent Healthcare Solutions, Inc.: ASCENT HEALTHCARE SOLUTIONS. Reprocessed Femoral Compression Device, Model 11165.
- Recall number
- Z-2196-2010
- Recalling firm
- Ascent Healthcare Solutions, Inc.
- Product
- ASCENT HEALTHCARE SOLUTIONS. Reprocessed Femoral Compression Device, Model 11165.
- Status
- Terminated
- Initiated
- 2010-06-23
- Posted
- 2010-08-10
- Terminated
- 2010-08-11
- Reason
- The FemoStop Devices may fail to inflate or hold pressure. A separation between the dome and arch base prevents the device from maintaining pressure when inflated.
- Root cause
- Reprocessing Controls
- Action
- Ascent sent an urgent medical device voluntary recall notification Letter and Response Form to each consignee on June 25, 2010. Consignees were requested to immediately examine their inventory of Ascent Reprocessed FemoStop devices with lot numbers located on an attached list; remove and quarantine all affected devices; complete the attached Recall Effectiveness Check Form; ship all affected product back to Ascent using the address indicated in the letter, and fax a completed Recall Effectiveness Check Form to 480-763-5350.
- Quantity
- 175 devices
- Distribution
- Devices were distributed to 8 consignees (end users/hospitals) located in VA, CA, FL, MI, WA.
- Lot, serial or model codes
- Lot: 869509, 878402, 878439, 879762, 879990, 880274.
- 510(k) numbers
- ["K011832"]
- PMA numbers
- not on file
- Product code
- NMF
- Firm FEI
- 1000132435
- Firm city
- Lakeland
- Firm state
- FL
- 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