FDA Device recall Z-1876-2013
Medtronic Mullins Transseptal Adult 7F, REF 008551
- FDA Device
- Class II
- terminated
- Published 2013-08-14
On 2013-08-14 the FDA classified a Class II recall of Medtronic Mullins Transseptal Adult 7F, REF 008551 by Medtronic Cardiac Rhythm Disease Management, citing medtronic identified a specific labeling issue for specific lots of Mullins Transseptal Catheter Introducer Sheath, model 008551, in which packages labeled as Mullins 7F (French)….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1876-2013 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2013-07-08 |
| Published | 2013-08-14 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Medtronic Cardiac Rhythm Disease Management |
| Distribution | US |
Product
Medtronic Mullins Transseptal Adult 7F, REF 008551. Intended for the introduction of cardiovascular catheters into the left side of the heart.
Reason
Medtronic identified a specific labeling issue for specific lots of Mullins Transseptal Catheter Introducer Sheath, model 008551, in which packages labeled as Mullins 7F (French) may actually contain an 8F(French) dilator. Medtronic is requesting the return of potentially mis-labeled Mullins Transseptal Catheter Introducer 7 French Sheaths. Due to the differences in size, an 8F dilator will not
Identifiers
| code_info | Lot Numbers: 50672012, 50676944, 50683123, 50693426, 50710622. |
|---|
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-1876-2013%22
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