DLP(R) Pericardial/Intracardiac Sump Cannulae, 20 Fr., P/N: 12112. This product is intended for draining the pericardial
FDA device recall Z-0609-2009 · posted 2009-01-26 · Terminated
Recall details
- Recalling firm
- Medtronic Cardiovascular Revascularization & Surgical Therap
- Reason for recall
- 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.
- Action taken
- 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.
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- DWF
- Quantity affected
- 380 US ; 180 OUS
- 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.
- Date initiated
- 2008-09-29
- Date posted
- 2009-01-26
- Date terminated
- 2011-05-07
- Location
- Brooklyn Park, MN
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| INTRACARDIAC SUMP 12010 (K850385) | Dlp, Inc. | 1985-04-29 |