FDA Medical Device Recalls (openFDA)
Terumo Cardiovascular Systems Corporation: Sarns Dual-stage Venous Return Cannulae, 32/40 Fr with 1/2" flare The Sarns Malleable Dual-stage Venous Return Catheters and Sarns Dual-stage Venous Return Cannula are indicated for single-tube venous drainage from the right atrium and vena cava during cardiopulmonary bypass surgery. These devices are indicated for up to 6 hours of use.
- Recall number
- Z-1223-2014
- Recalling firm
- Terumo Cardiovascular Systems Corporation
- Product
- Sarns Dual-stage Venous Return Cannulae, 32/40 Fr with 1/2" flare The Sarns Malleable Dual-stage Venous Return Catheters and Sarns Dual-stage Venous Return Cannula are indicated for single-tube venous drainage from the right atrium and vena cava during cardiopulmonary bypass surgery. These devices are indicated for up to 6 hours of use.
- Status
- Terminated
- Initiated
- 2014-03-03
- Posted
- 2014-03-19
- Terminated
- 2014-08-12
- Reason
- During in-process inspection, Terumo Cardiovascular Systems (Terumo CVS) identified exposed basket wire on certain product lots of Sarns Malleable Dual-stage Venous Return Cannulae and Sarns Dual-stage Venous Return Cannulae.
- Root cause
- Device Design
- Action
- Terumo sent an Urgent Medical Device Recall letter dated March 3, 2014, to all affected consignees. The letter included the reason for removal, potential hazards, and customer instructions. Terumo CVS advised users to stop using the affected devices and return any unused product on hand. Questions or concerns were directed to Terumo CVS Customer Service: 1-800-521-2818 M-F, 8am-6pm. For questions regarding this recall call 734-741-6173.
- Quantity
- not on file
- Distribution
- Worldwide Distribution - USA including CA, CT, FL, GA, IL, IN, LA, MI, MN, MO, NC, NY, PA, TN, TX, and Internationallly to United Arab Emirates (UAE), Taiwan, Thailand, Malaysia, Belgium, Japan, Mexico, and Canada.
- Lot, serial or model codes
- Catalog Number 16472
- 510(k) numbers
- ["K920902"]
- PMA numbers
- not on file
- Product code
- DWF
- Firm FEI
- 1828100
- Firm city
- Ann Arbor
- Firm state
- MI
- 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