FDA Medical Device Recalls (openFDA)
Surge Medical Solutions, LLC: Surge Medical Solutions 15 Fr. (5.0mm) Retrograde Cardioplegia Cannula, self-inflating balloon 18 mm, guidewire stylet, sterile, REF CODE: RSG-M014S.
- Recall number
- Z-0892-2007
- Recalling firm
- Surge Medical Solutions, LLC
- Product
- Surge Medical Solutions 15 Fr. (5.0mm) Retrograde Cardioplegia Cannula, self-inflating balloon 18 mm, guidewire stylet, sterile, REF CODE: RSG-M014S.
- Status
- Terminated
- Initiated
- 2007-04-17
- Posted
- 2007-06-06
- Terminated
- 2009-03-10
- Reason
- The device may leak between the two lumens or at the stop cock, which could result in inaccurate coronary sinus pressure readings.
- Root cause
- Other
- Action
- Consignees were notified and requested to return the recalled products via recall letter dated 4/17/07.
- Quantity
- 2,211 for all Recalls Z-0892-0904-2007
- Distribution
- Worldwide, USA, Argentina, Germany, Ireland, Italy, Lebanon, Saudi Arabia, Turkey, and the United Kingdom.
- Lot, serial or model codes
- All lot numbers beginning with 0610, 0611, 0612, 0701 or 0702.
- 510(k) numbers
- ["K964393"]
- PMA numbers
- not on file
- Product code
- DWF
- Firm FEI
- 3003964340
- Firm city
- Grand Rapids
- 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