MFAFDA Class 3
Device, Removal, Pacemaker Electrode, Percutaneous
Device family · Unknown
Automated profile from regulatory + adverse-event registries · AI-reviewed · expert clinical sign-off in progress — not yet independently verified.
FDA clearances
62
Manufacturers
1
Flagged signals
16
Adverse-event reports
1,383
Code matrix
| FDA product code | MFA |
| Device class | Class 3 |
| Regulation | — |
| GMDN | — (crosswalk pending) |
| Implantable | No |
| Life-sustaining | No |
Adverse-event signals
Public · always freeMAUDE disproportionality (PRR), flagged where PRR ≥ 2, χ² ≥ 4, count ≥ 3.
| Event type | Year | Reports | PRR | χ² |
|---|---|---|---|---|
| Death | 2013 | 18 | 23.5 | 369 |
| Death | 2014 | 14 | 18.3 | 213 |
| Death | 2021 | 24 | 9.1 | 168 |
| Death | 2020 | 20 | 7.6 | 109 |
| Death | 2018 | 17 | 6.5 | 74 |
| Death | 2019 | 15 | 5.7 | 54 |
| Death | 2012 | 38 | 4.4 | 96 |
| Death | 2013 | 31 | 3.6 | 55 |
| Death | 2014 | 30 | 3.4 | 50 |
| Death | 2017 | 25 | 2.9 | 29 |
| Death | 2010 | 23 | 2.6 | 22 |
| Death | 2016 | 22 | 2.5 | 19 |
| Death | 2024 | 21 | 2.4 | 16 |
| Death | 2025 | 19 | 2.2 | 11 |
| Death | 2015 | 19 | 2.2 | 11 |
| Death | 2011 | 19 | 2.2 | 11 |
Device-level recall linkage pending an FDA-recalls product-code re-ingest. Class 3 family · 1,383 total adverse-event reports.
Manufacturer landscape
| Manufacturer | Clearances | Latest | Concern |
|---|---|---|---|
| Spectranetics (Philips) | 62 | 2025 | — |
Concern score lights up where a maker maps to a scored entity (depth fast-follow).
Recent FDA clearances
GlideLight Laser Sheath · Spectranetics (Philips)PMA · 2025-12-18
Spectranetics Laser Sheath (GlideLight/SLS) · Spectranetics (Philips)PMA · 2024-09-05
Spectranetics Laser Sheath (SLS ll/GlideLight) · Spectranetics (Philips)PMA · 2023-05-04
Glidelight Laser Sheath · Spectranetics (Philips)PMA · 2021-09-02
SLS/GlideLight · Spectranetics (Philips)PMA · 2020-05-06
Spectranetics Laser Sheaths SLS · Spectranetics (Philips)PMA · 2019-10-21
SLS/GlideLight · Spectranetics (Philips)PMA · 2019-10-07
Spectranetics Laser Sheath (SLS) II and GlideLight Laser Sheath · Spectranetics (Philips)PMA · 2019-06-28
Spectranetics Laser Sheaths SLS · Spectranetics (Philips)PMA · 2018-11-16
Spectranetics Laser Sheaths SLS · Spectranetics (Philips)PMA · 2018-10-15
SLS ll/GlideLight Catheters · Spectranetics (Philips)PMA · 2018-08-14
SLS II/GlideLight catheters · Spectranetics (Philips)PMA · 2018-06-28
SLS II/Glide Light Catheters · Spectranetics (Philips)PMA · 2018-05-31
Spectranetics Laser Sheaths SLS (SLS ll/GlideLight) · Spectranetics (Philips)PMA · 2018-05-08
Spectranetics Laser Sheath II (SLS II) GlideLight Catheters · Spectranetics (Philips)PMA · 2017-07-31
SLS / GlideLight · Spectranetics (Philips)PMA · 2017-07-18
Spectranetics Laser Sheth (SLS) II, Glidel Light Laser Sheath · Spectranetics (Philips)PMA · 2017-05-10
ELCA and SLS/GlideLight Catheter · Spectranetics (Philips)PMA · 2017-04-24
SLS II/GLIDELIGHT CATHETERS · Spectranetics (Philips)PMA · 2017-01-05
SPECTRANETICS LASER SHEATHS · Spectranetics (Philips)PMA · 2016-06-16
SPECTRANETICS CVX-300 EXCIMER LASER SYSTEM & LASER SHEATH · Spectranetics (Philips)PMA · 2016-04-13
SLS II AND GLIDELIGHT LASER SHEATH KITS · Spectranetics (Philips)PMA · 2015-12-03
SPECTRANETICS LASER SHEATHS (SLS) · Spectranetics (Philips)PMA · 2015-01-08
SPECTRANETICS LASER SHEATH SLS · Spectranetics (Philips)PMA · 2014-10-30
SPECTRANETICS LASER SHEATH (SLS, SLS II, AND GLIDELIGHT) · Spectranetics (Philips)PMA · 2014-10-09
Sources: FDA 510(k)/PMA · openFDA MAUDE · FDA device classification · MedevIQ manufacturer-canonical. Registry data, AI-reviewed; expert clinical sign-off in progress.