FDA Device recall Z-0908-2013
Medtronic DPL Single Stage Venous Cannula with Metal Tip, used in cardiopulmonary bypass procedures
- FDA Device
- Class II
- terminated
- Published 2013-03-13
On 2013-03-13 the FDA classified a Class II recall of Medtronic DPL Single Stage Venous Cannula with Metal Tip, used in cardiopulmonary bypass procedures by Medtronic Cardiac Rhythm Disease Management, citing potential for uncharacteristically rough metal edges to occur along the inner diameter of the metal tip side ports of the cannula.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0908-2013 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2013-02-19 |
| Published | 2013-03-13 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Medtronic Cardiac Rhythm Disease Management |
| Distribution | US |
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.
Identifiers
| code_info | Model Catalog# Lot 67312 6731210NO 2012090293 67312 6731210NO 2012090294 67312 6731210NO 20120…Model Catalog# Lot 67312 6731210NO 2012090293 67312 6731210NO 2012090294 67312 6731210NO 2012090337 67312 6731210NO 2012100039 67312 6731210NO 2012100086 67312 6731210NO 2012100087 67312 6731210NO 2012100161 67312 6731210NO 2012110326 67312 6731210NO 2012110767 67312 6731210NO 2012110899 67312 6731210NO 2012111721 67314 6731410NO 2012090416 67314 6731410NO 2012090435 67314 6731410NO 2012090571 67314 6731410NO 2012090572 67314 6731410NO 2012100040 67314 6731410NO 2012100041 67314 6731410NO 2012100107 67314 6731410NO 2012101346 67314 6731410NO 2012110007 67314 6731410NO 2012110008 67314 6731410NO 2012110327 67314 6731410NO 2012111419 67314 6731410NO 2012111420 67314 6731410NO 2012120019 67316 6731610NO 2012090239 67316 6731610NO 2012090389 67316 6731610NO 2012090854 67316 6731610NO 2012091024 67316 6731610NO 2012110030 67316 6731610NO 2012110144 67316 6731610NO 2012110394 67316 6731610NO 2012110395 67316 6731610NO 2012110396 67318 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0908-2013%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.