Medtronic — Class I medical device recall Z-1276-2015
Terminated recall by Medtronic Inc. Cardiac Rhythm Disease Management, reported 2015-03-25, distributed nationwide. Clinicians observed debris, appearing to originate from the hemostasis valve on the proximal end of the Steera
| Recall number | Z-1276-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Medtronic Inc. Cardiac Rhythm Disease Management, Saint Paul, MN, United States |
| Recall initiated | 2015-02-23 |
| Classified | 2015-03-17 |
| Reported by FDA | 2015-03-25 |
| Terminated | 2015-10-07 |
| Distributed | Nationwide (US) |
| Countries outside the US | AT, BE, DE, DK, ES, FR, GB, NL, PL |
| Lot numbers | 54790, 54860, 54876, 54877, 54878, 72417, 72419 |
Product
Medtronic, 10 Fr FlexCath Select Steerable Sheath 990065. The FlexCath Select Steerable Sheath (10 Fr Select) is used for percutaneous catheter introduction into the vasculature and chambers of the heart. The sheath is a single-use device and is not implantable.
Reason for recall
Clinicians observed debris, appearing to originate from the hemostasis valve on the proximal end of the Steerable Sheath, outside of the patients bodies.
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-1276-2015. 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.