Surge Medical Solutions, LLC Surge Medical Solutions brand 15 Fr. (5.0mm) Surge Medical Solutions 15 Fr. (5.0mm) Retrograde Cardioplegia Cannula, self-inflating balloon 14 mm, handle stylet, sterile, REF CODE: RSH-S014S. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Surge Medical Solutions brand 15 Fr. (5.0mm) Surge Medical Solutions 15 Fr. (5.0mm) Retrograde Cardioplegia Cannula, self-inflating balloon 14 mm, handle stylet, sterile, REF CODE: RSH-S014S.
Brand
Surge Medical Solutions, LLC
Lot Codes / Batch Numbers
All lot numbers beginning with 0610, 0611, 0612, 0701 or 0702.
Products Sold
All lot numbers beginning with 0610, 0611, 0612, 0701 or 0702.
Surge Medical Solutions, LLC is recalling Surge Medical Solutions brand 15 Fr. (5.0mm) Surge Medical Solutions 15 Fr. (5.0mm) Retrograde Cardi due to The device may leak between the two lumens or at the stop cock, which could result in inaccurate coronary sinus pressure readings.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
The device may leak between the two lumens or at the stop cock, which could result in inaccurate coronary sinus pressure readings.
Recommended Action
Per FDA guidance
Consignees were notified and requested to return the recalled products via recall letter dated 4/17/07.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026