Medtronic Mullins Transseptal Adult 7F — Class II medical device recall Z-1876-2013
Terminated recall by Medtronic Inc. Cardiac Rhythm Disease Management, reported 2013-08-14, distributed nationwide. Medtronic identified a specific labeling issue for specific lots of Mullins Transseptal Catheter Introducer Sh
| Recall number | Z-1876-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Medtronic Inc. Cardiac Rhythm Disease Management, Saint Paul, MN, United States |
| Recall initiated | 2013-07-08 |
| Classified | 2013-08-05 |
| Reported by FDA | 2013-08-14 |
| Terminated | 2014-03-06 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU, BR, CL, IN, SG |
| Quantity | 269 |
| Reason classes | labeling |
| Lot numbers | 50672012, 50676944, 50683123, 50693426, 50710622 |
| Model numbers | 008551 |
Product
Medtronic Mullins Transseptal Adult 7F, REF 008551. Intended for the introduction of cardiovascular catheters into the left side of the heart.
Reason for recall
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
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1876-2013. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.