Z-0897-2007

Surge Medical Solutions 15 Fr. (5.0mm) Retrograde Cardioplegia Cannula, 18 mm self-inflating balloon...

Name: Z-0897-2007 Surge Medical Solutions 15 Fr. (5.0mm) Retrograde Cardioplegia Cannula, 18 mm self-inflating balloon...
Creator: Surge Medical Solutions, LLC
Published: 2007-04-17
License: https://open.fda.gov/license/

Surge Medical Solutions, LLC / initiated 2007-04-17 / Terminated

FDA source

Surge Medical Solutions, LLC began a recall of Surge Medical Solutions 15 Fr. (5.0mm) Retrograde Cardioplegia Cannula, 18 mm self-inflating balloon, sure-touch handle, rigid insertion stylet, 12.5' length... on 2007-04-17. The reason FDA records is "The device may leak between the two lumens or at the stop cock, which could result in inaccurate coronary sinus pressure readings". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0897-2007
Status: Terminated
Initiated: 2007-04-17
Posted: 2007-06-06
Terminated: 2009-03-10
Recalling firm: Surge Medical Solutions, LLC
Product: Surge Medical Solutions 15 Fr. (5.0mm) Retrograde Cardioplegia Cannula, 18 mm self-inflating balloon, sure-touch handle, rigid insertion stylet, 12.5' length (31.8cm), sterile, REF CODE: RSH-M014S-L.
Product code: DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
Reason for recall: The device may leak between the two lumens or at the stop cock, which could result in inaccurate coronary sinus pressure readings.
FDA root cause: Other
Action: Consignees were notified and requested to return the recalled products via recall letter dated 4/17/07.
Quantity in commerce: 2,211 for all Recalls Z-0892-0904-2007
Distribution: Worldwide, USA, Argentina, Germany, Ireland, Italy, Lebanon, Saudi Arabia, Turkey, and the United Kingdom.
Product codes and lots: All lot numbers beginning with 0610, 0611, 0612, 0701 or 0702.

Product code DWF

K964393Class IIChase Retrograde Cardioplegia CannulaChase Medical, Inc. / cleared 1997-04-23

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)