Recall Z-2571-2019— Medtronic Vascular
Class I · Completed
Class I FDA medical device recall by Medtronic Vascular, initiated 2019-03-15, terminated 2024-04-26. It names 2 FDA 510(k) clearances: K132673, K042489. Product: SHERPA NX ACTIVE GUIDING CATHETER, 6F, AR2.0, 100CM.070", REF SA6AR20. 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..
- Recalling firm
- Medtronic Vascular
- Classification
- Class I
- Status
- Completed
- Initiated
- 2019-03-15
- Terminated
- 2024-04-26
- Firm location
- Danvers, MA, United States
510(k) clearances named in this recall
2 on FDA's record- K132673 — 5F & 6F LAUNCHER GUIDE CATHETER, 5F SHERPA ACTIVE NX GUIDE CATHETER, 6F Z4 GUIDING CATHETER
- K042489 — 6F Z4 GUIDE CATHETER
K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
SHERPA NX ACTIVE GUIDING CATHETER, 6F, AR2.0, 100CM.070", REF SA6AR20. for cardiovascular use
Reason for recall
There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.
Data sourced from openFDA. This site is unofficial and independent of the FDA.