SHERPA NX ACTIVE SA6ERADRRecalls & reported problems
Medtronic, Inc. · CATHETER SA6ERADR SA 6F 100CM ERDR · Class 2
All models of SHERPA NX ACTIVE (190)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 0
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
No MAUDE adverse event reports in our data reference this device identifier directly.
1 FDA recall record name this device's identifier.
190 other recalls cover devices cleared under the same FDA submission (K042489); they may or may not involve this specific model.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Recalls naming this device
- Mar 15, 2019Class ITerminated
There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.
Z-2724-2019 · Root cause: Component design/selection · Recall details · FDA record ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K042489. One submission often covers many models, so check the product and lot details in each record.
- Z-2665-2019 · Mar 15, 2019 · TerminatedSHERPA NX ACTIVE GUIDING CATHETER, 6F JL5.0 SH, .070", REF SA6JL50SH. for cardiovascular use
- Z-2700-2019 · Mar 15, 2019 · TerminatedSHERPA NX ACTIVE GUIDING CATHETER, 6F AL2.5, .070:, REF SA6AL25. for cardiovascular use
- Z-2697-2019 · Mar 15, 2019 · TerminatedSHERPA NX ACTIVE GUIDING CATHETER, 6F SAL2.0, .070", REF SA6SAL20. for cardiovascular use
- Z-2672-2019 · Mar 15, 2019 · TerminatedSHERPA NX ACTIVE GUIDING CATHETER, 6F AL3.0 SH, .070", REF SA6AL30SH. for cardiovascular use
- Z-2614-2019 · Mar 15, 2019 · TerminatedSHERPA NX ACTIVE GUIDING CATHETER, 6F SR3.5 SH, .070" REF SA6SR35SH. for cardiovascular use
- Z-2679-2019 · Mar 15, 2019 · TerminatedSHERPA NX ACTIVE GUIDING CATHETER, 6F AL3.0, .070", REF SA6AL30. for cardiovascular use
- Z-2710-2019 · Mar 15, 2019 · TerminatedSHERPA NX ACTIVE GUIDING CATHETER, 6F M RADIAL, .070", REF SA6MRADIAL. for cardiovascular use
- Z-2654-2019 · Mar 15, 2019 · TerminatedSHERPA NX ACTIVE GUIDING CATHETER, 6F CHAMP1.0, .070", REF SA6CHAMP10. for cardiovascular use
- Z-2720-2019 · Mar 15, 2019 · TerminatedSHERPA NX ACTIVE GUIDING CATHETER, 6F SAL3.0, .070", REF SA6SAL30. for cardiovascular use
- Z-2669-2019 · Mar 15, 2019 · TerminatedSHERPA NX ACTIVE GUIDING CATHETER, 6F MP ST, .070", REF SA6MPST. for cardiovascular use
- Z-2705-2019 · Mar 15, 2019 · TerminatedSHERPA NX ACTIVE GUIDING CATHETER, 6F SAL1.0 SH, .070", REF SA6SAL10SH. for cardiovascular use
- Z-2624-2019 · Mar 15, 2019 · TerminatedSHERPA NX ACTIVE GUIDING CATHETER, 6F AL1.0, .070", REF SA6AL10. for cardiovascular use
- Z-2723-2019 · Mar 15, 2019 · TerminatedSHERPA NX ACTIVE GUIDING CATHETER, 6F SAL2.0 SH, .070", REF SA6SAL20SH. for cardiovascular use
- Z-2620-2019 · Mar 15, 2019 · TerminatedSHERPA NX ACTIVE GUIDING CATHETER, 6F JL3.0, .070", REF SA6JL30. for cardiovascular use
- Z-2740-2019 · Mar 15, 2019 · TerminatedSHERPA NX ACTIVE GUIDING CATHETER, 6F EL GAMAL, .070", REF SA6ELGAMAL. for cardiovascular use
…and 175 more.
Other CATHETER, PERCUTANEOUS devices
- WATCHMAN FXD Curve™ Access System M635TU80020Boston Scientific Corporation · Catheter, percutaneous1 recall47 deaths654 reports
- NA C315HIS02Medtronic, Inc. · Catheter, percutaneous1 recall369 reports
- WATCHMAN TruSteer™ Access System M635TU90050Boston Scientific Corporation · Catheter, percutaneous1 recall28 deaths302 reports
- Guidezilla™ II H7493933515060Boston Scientific Corporation · CATHETER, PERCUTANEOUS1 recall3 deaths278 reports
- Velocity Delivery Microcatheter VEL160STR-APenumbra, Inc. · CATHETER, PERCUTANEOUS297 reports
- Guidezilla™ H7493924215050Boston Scientific Corporation · CATHETER, PERCUTANEOUS294 reports
- WATCHMAN™ TruSeal™ Access System M635TU70020Boston Scientific Corporation · Catheter, percutaneous1 recall11 deaths217 reports
- Lantern Delivery Catheter PXSLIMLAN135T45Penumbra, Inc. · CATHETER, PERCUTANEOUS220 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page