Recall Z-0908-2013— Medtronic Inc. Cardiac Rhythm Disease Management
Class II · Terminated
Class II FDA medical device recall by Medtronic Inc. Cardiac Rhythm Disease Management, initiated 2013-02-19, terminated 2013-11-21. It names 2 FDA 510(k) clearances: K120988, K842375. Product: Medtronic DPL Single Stage Venous Cannula with Metal Tip, used in cardiopulmonary bypass procedures. Model numbers: 67312; 67314; CB67314; 67316; 67318; CB67318; 67320; 69312; 69314; 69316; 69318; 69320; 69322; 69324; 69328; 69331.. Reason: Potential for uncharacteristically rough metal edges to occur along the inner diameter of the metal tip side ports of the cannula..
- Recalling firm
- Medtronic Inc. Cardiac Rhythm Disease Management
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2013-02-19
- Terminated
- 2013-11-21
- Firm location
- Saint Paul, MN, United States
510(k) clearances named in this recall
2 on FDA's record- K120988 — DLP SINGLE STAGE VENOUS CANNULA, DLP RIGHT ANGLE SINGLE STAGE VENOUS CANNULA, DLP SINGLE STAGE VENOUS CANNULA WITH RIGHT
- K842375 — VENOUS CANNULA W/BENT, TIP WIRE
K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
Medtronic DPL Single Stage Venous Cannula with Metal Tip, used in cardiopulmonary bypass procedures. Model numbers: 67312; 67314; CB67314; 67316; 67318; CB67318; 67320; 69312; 69314; 69316; 69318; 69320; 69322; 69324; 69328; 69331.
Reason for recall
Potential for uncharacteristically rough metal edges to occur along the inner diameter of the metal tip side ports of the cannula.
Data sourced from openFDA. This site is unofficial and independent of the FDA.