FDA Device recall Z-1276-2015
Medtronic, 10 Fr FlexCath Select Steerable Sheath 990065
- FDA Device
- Class I
- terminated
- Published 2015-03-25
On 2015-03-25 the FDA classified a Class I recall of Medtronic, 10 Fr FlexCath Select Steerable Sheath 990065 by Medtronic Cardiac Rhythm Disease Management, citing clinicians observed debris, appearing to originate from the hemostasis valve on the proximal end of the Steerable Sheath, outside of the patients bodies.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1276-2015 |
| Classification | Class I |
| Status | terminated |
| Initiated | 2015-02-23 |
| Published | 2015-03-25 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Medtronic Cardiac Rhythm Disease Management |
| Distribution | US |
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
Clinicians observed debris, appearing to originate from the hemostasis valve on the proximal end of the Steerable Sheath, outside of the patients bodies.
Identifiers
| code_info | Lot Number: 54790, 54860, 54876, 54877, 54878 ,72417, 72419. |
|---|
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-1276-2015%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.