FDA Medical Device Recalls (openFDA)
Terumo Cardiovascular Systems Corp: Terumo Sarns brand Soft-Flow Aortic Cannula with flange, angled, wire-reinforced, with Luer, 6 mm (18 Fr) OD with 3/8 inch connector, 14 inches (35 cm) long; catalog number 7080.
- Recall number
- Z-0181-06
- Recalling firm
- Terumo Cardiovascular Systems Corp
- Product
- Terumo Sarns brand Soft-Flow Aortic Cannula with flange, angled, wire-reinforced, with Luer, 6 mm (18 Fr) OD with 3/8 inch connector, 14 inches (35 cm) long; catalog number 7080.
- Status
- Terminated
- Initiated
- 2005-10-19
- Posted
- 2005-11-23
- Terminated
- 2006-03-10
- Reason
- The product is labeled as sterile, but the firm has determined that the suture flange may tear through the front of the package.
- Root cause
- Other
- Action
- Consignees were notified via telephone, and a recall letter dated 10/19/05 sent to each consignee, beginning on 10/18/05. International affiliates were notified via email.
- Quantity
- 48
- Distribution
- California, Indiana, Missouri, Brazil and Germany.
- Lot, serial or model codes
- All lots (0332197, 0349597, 0360492, 0369078, 0373045, 0382401, 0391806 and 0399838).
- 510(k) numbers
- ["K934127"]
- 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