Terumo Medical Corporation
FDA Regulatory Profile
Terumo Medical Corporation appears in FDA public data with 18 recalls — including 3 Class I (most serious) —, 14 510(k) clearances, 8 FDA inspections, and 1 compliance action on record. Its most recent recall (Z-1374-2019, Class I) was initiated on April 26, 2019. Its most recent 510(k) clearance was granted on July 27, 2023.
Summary
- Total Recalls
- 18 (3 Class I)
- 510(k) Clearances
- 14
- Inspections
- 8
- Compliance Actions
- 1
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-1374-2019 | Class I | SOLOPATH Balloon Expandable TransFemoral System, Model Numbers STFI-1425, STFI-1435, STFI-1625, | April 26, 2019 |
| Z-1376-2019 | Class I | Portico Solo Re-Collapsible Access System , Model Numbers PRTSOLO-19, PRTSOLO-20 | April 26, 2019 |
| Z-1375-2019 | Class I | SOLOPATH Re-Collapsible Access System, Model Numbers SR-1925, SR-1935, SR-2025, SR-2035, SR- | April 26, 2019 |
| Z-2000-2019 | Class II | Terumo Sur-vet Needle, 22G x 3/4", Product Code 100215 | February 8, 2019 |
| Z-1998-2019 | Class II | Terumo Sur-vet Needle, 20G x 1", Product Code 100204 | February 8, 2019 |
| Z-2002-2019 | Class II | Terumo Sur-vet Needle, 22G x 3/4", Product Code 100279 | February 8, 2019 |
| Z-2001-2019 | Class II | Terumo Sur-vet Needle, 25G x 5/8", Product Code 100220 | February 8, 2019 |
| Z-2006-2019 | Class II | Terumo Needle, 30G x 1/2", Product Code NN3013R | February 8, 2019 |
| Z-1999-2019 | Class II | Terumo Sur-vet Needle, 22G x 1", Product Code 100211 | February 8, 2019 |
| Z-2005-2019 | Class II | Terumo Needle, 23G x 1", Product Code NN2325R | February 8, 2019 |
| Z-2004-2019 | Class II | Terumo Needle, 18G x 1", Product Code NN1825R | February 8, 2019 |
| Z-2003-2019 | Class II | Terumo Sur-vet Needle, 25G x 5/8", Product Code 100280 | February 8, 2019 |
| Z-0725-2018 | Class II | Destination Guiding Sheath catheter introducer, Catalog Number: RSR06 Product Usage: The Destina | September 12, 2017 |
| Z-2738-2016 | Class II | PINNACLE¿ Introducer Sheath PINNACLE PRECISION ACCESS SYSTEM¿ Sheath PINNACLE¿ TIF TIP" Introducer | March 16, 2016 |
| Z-2033-2017 | Class II | Destination Renal Guiding Sheath Intended for the introduction of interventional and diagnostic d | November 6, 2015 |
| Z-1896-2017 | Class II | SurFlo IV Catheter | August 5, 2015 |
| Z-1611-2013 | Class II | Pinnacle¿ Destination¿ Peripheral Guiding Sheath, 8 French, 90cm, Straight Tip, Cross Cut Valve. | May 30, 2013 |
| Z-1612-2013 | Class II | Terumo Glidesheath (tm), 6 French, Nitinol wire, product code 15-1060. Used to facilitate placing | May 30, 2013 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K231044 | R2P Navicross | July 27, 2023 |
| K213531 | TR BAND Radial Compression Device | December 20, 2021 |
| K193125 | R2P Destination Slender Guiding Sheath | January 6, 2020 |
| K181237 | Glidesheath Slender Tibial Pedal Kit | August 3, 2018 |
| K173831 | Glidesheath Slender | May 8, 2018 |
| K172995 | Destination Carotid Guiding Sheath, Destination Peripheral Guiding Sheath, Destination Renal Guiding | November 21, 2017 |
| K171491 | R2P Destination Slender Guiding Sheath | October 5, 2017 |
| K152173 | Glidesheath | December 1, 2015 |
| K152525 | TR BAND Radial Compression Device | November 10, 2015 |
| K151471 | Radifocus Glidewire Endoscopic Wire | September 17, 2015 |
| K142183 | GLIDESHEATH SLENDER | November 21, 2014 |
| K122590 | RADIFOCUS GLIDEWIRE ADVANTAGE, RADIFOCUS GLIDEWIRE ADVANTAGE | March 1, 2013 |
| K122980 | GLIDESHEATH SLENDER MODEL RM* ES6J10HQS, GLIDESHEATH SLENDER MODEL RM* ES6F16HQ, GLIDESHEATH SLENDER | December 11, 2012 |
| K112382 | TERUMO ASPRIATION CATHETER | December 14, 2011 |