DLP(R) Pericardial/Intracardiac Sump Cannulae, 20 Fr., P/N:… recallZ-0609-2009 · Medtronic Cardiovascular Revascularization & Surgical Therap · initiated Sep 29, 2008
Terminated All recalls posted in January 2009
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Medtronic Cardiovascular Revascularization & Surgical Therap or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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.
FDA root cause category: Nonconforming Material/Component
What the company is doing
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.
Recall details
- Recall number
- Z-0609-2009
- Recall class
- Not yet classified by the FDA
- Status
- Terminated
- Initiated by the company
- Sep 29, 2008
- Posted by the FDA
- Jan 26, 2009
- Recalling firm
- Medtronic Cardiovascular Revascularization & Surgical Therap
- Quantity
- 380 US ; 180 OUS
- Product code
- DWF
- FDA submissions
- K850385
- Distribution
- Worldwide Distribution --- including states of NC, PA, IA, WI, IN, VA, IL, KY, and TX, and countries of Australia, France, Hong Kong, Netherlands, and Poland.
Product description
DLP(R) Pericardial/Intracardiac Sump Cannulae, 20 Fr., P/N: 12112. This product is intended for draining the pericardial sac or the cardiac chambers.
Code information (models, lots, serial numbers)
Lot number 2006100305
Other devices under the same FDA submission
3 devices cleared under K850385 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- DLP® 12010Medtronic, Inc. · CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS1 recall3 reports
- DLP® 12012Medtronic, Inc. · CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS1 recall0 reports
- DLP® 12112Medtronic, Inc. · CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS1 death3 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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