Medtronic DPL Single Stage Venous Cannula with Metal Tip, used in cardiopulmonary bypass procedures. Model numbers: 6731
FDA device recall Z-0908-2013 · posted 2013-03-05 · Terminated
Recall details
- Recalling firm
- Medtronic Inc. Cardiac Rhythm Disease Management
- Reason for recall
- Potential for uncharacteristically rough metal edges to occur along the inner diameter of the metal tip side ports of the cannula.
- Action taken
- Consignees were sent a Medtronic "Urgent Medical Device Recall" letter dated February 19, 2013. The letter described the problem and the product involved in the recall. Advised consignees to quarantine affected product, and return the product to Medtronic. Requested consignees the complete and return the attached Customer confirmation certificate. If product has been forwarded to another facility, requested consignees to notify the facility of the issue.
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- DWF
- Quantity affected
- 13,691 (6711 USA; 6980 OUS)
- Distribution
- Worldwide distribution, including USA nationwide, Albania, Algeria, Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, Colombia, Croatia, Cyprus, Czech Republic, Denmark, Ecuador, Egypt, F
- Date initiated
- 2013-02-19
- Date posted
- 2013-03-05
- Date terminated
- 2013-11-21
- Location
- Saint Paul, MN
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| DLP SINGLE STAGE VENOUS CANNULA, DLP RIGHT ANGLE SINGLE STAGE VENOUS CANNULA, DLP SINGLE STAGE VENOUS CANNULA WITH RIGHT (K120988) | Medtronic, Inc. | 2012-07-25 |
| VENOUS CANNULA W/BENT, TIP WIRE (K842375) | Dlp, Inc. | 1984-08-10 |