FDA Device recall Z-2685-2019
SHERPA NX ACTIVE GUIDING CATHETER, 6F RCB SH, .070", REF SA6RCBSH. for cardiovascular use
- FDA Device
- Class I
- completed
- Published 2019-10-09
On 2019-10-09 the FDA classified a Class I recall of SHERPA NX ACTIVE GUIDING CATHETER, 6F RCB SH, .070", REF SA6RCBSH. for cardiovascular use by Medtronic Vascular, citing there is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2685-2019 |
| Classification | Class I |
| Status | completed |
| Initiated | 2019-03-15 |
| Published | 2019-10-09 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Medtronic Vascular |
| Distribution | n/a |
Product
SHERPA NX ACTIVE GUIDING CATHETER, 6F RCB SH, .070", REF SA6RCBSH. for cardiovascular use
Reason
There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.
Identifiers
| code_info | GTIN: 00613994823274 All Lot/Serial Numbers |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: completed.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2685-2019%22
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