Medtronic Cardiovascular Revascularization & Surgical Therap DLP(R) Pericardial/Intracardiac Sump Cannulae, 20 Fr., P/N: 12112. This product is intended for draining the pericardial sac or the cardiac chambers. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
DLP(R) Pericardial/Intracardiac Sump Cannulae, 20 Fr., P/N: 12112. This product is intended for draining the pericardial sac or the cardiac chambers.
Brand
Medtronic Cardiovascular Revascularization & Surgical Therap
Lot Codes / Batch Numbers
Lot number 2006100305
Products Sold
Lot number 2006100305
Medtronic Cardiovascular Revascularization & Surgical Therap is recalling DLP(R) Pericardial/Intracardiac Sump Cannulae, 20 Fr., P/N: 12112. This product is intended for dra due to Separates: Six complaints were received from two locations. In all cases the sump tip assembly separated from the tubing during device removal and ha. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Separates: Six complaints were received from two locations. In all cases the sump tip assembly separated from the tubing during device removal and had to be retrieved from the patient. There were no adverse events affecting these patients.
Recommended Action
Per FDA guidance
Consignees were sent a "Medtronic Urgent Medical Device Recall Notice" dated October 1, 2008. The letter described the product and issue. It also requested its customers to return the product and to complete, sign and fax the Recall Certificate "Medtronic Recall Certificate (FCA 0902)". For further information, please contact Medtronic Cardiovascular Revascularization & Surgical Therap by telephone at 763-391-9000.
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 noticeDistribution
As reported by FDA
IL, IN, IA, KY, NC, PA, TX, VA, WI
Page updated: Jan 10, 2026