Recall Z-2636-2019— 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 M RESS, .070", REF SA6MRESS. 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 M RESS, .070", REF SA6MRESS. 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.