Vascutek, Ltd.
FDA Regulatory Profile
Vascutek, Ltd. appears in FDA public data with 6 recalls, 26 510(k) clearances, 2 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-1492-2026, Class II) was initiated on December 18, 2025. Its most recent 510(k) clearance was granted on February 27, 2025.
Summary
- Total Recalls
- 6
- 510(k) Clearances
- 26
- Inspections
- 2
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-1492-2026 | Class II | Gelsoft Plus, REF: 635024PE, 631514PE, 631222PE, 633008PE, 633010PE, 633007PE, 636010PE, 632522PE, 6 | December 18, 2025 |
| Z-2542-2021 | Class II | The Instructions for Use (IFU) for: Gelsoft Plus Bifurcate, Gelsoft Plus Ax-Fem, GelsoftPlus ERS Ax | July 8, 2021 |
| Z-2543-2021 | Class II | The Instructions for Use (IFU) for: Carotid Patch and Gelsoft Patch vascular patches. FSN says | July 8, 2021 |
| Z-1912-2015 | Class II | Gelseal Straight Diameter 8mm Length 15cm. Vascular graft prosthesis is an implanted device inten | May 15, 2015 |
| Z-1913-2015 | Class II | Gelseal Straight Diameter 8mm Length 30cm. Vascular graft prosthesis is an implanted device inten | May 15, 2015 |
| Z-2266-2014 | Class II | Gelweave (TM) Vascular Prostheses Manufactured by - VASCUTEK Ltd a TERUMO company | July 15, 2014 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K241550 | Gelweave Vascular Prostheses | February 27, 2025 |
| K241070 | Gelsoft Plus Vascular Prostheses | November 15, 2024 |
| K202703 | Vascutek Gelsoft Plus ERS Vascular Graft | April 6, 2021 |
| K200955 | Vascutek Gelseal Patch, Vascutek Gelsoft Patch, Vascutek Thin Wall Carotid Patch | July 8, 2020 |
| K162803 | Gelseal Vascular Grafts, Gelsoft Vascular Grafts, Gelsoft Plus Vascular Grafts | July 14, 2017 |
| K162794 | Gelweave Vascular Grafts | June 30, 2017 |
| K093817 | GELWEAVE BRANCHED VASCULAR GRAFTS WITH RADIOPAQUE MARKERS | January 7, 2010 |
| K092863 | MAXIFLO, TAPERFLO | October 8, 2009 |
| K091778 | VASCUTEK COBRAHOOD EPTFE VASCULAR GRAFTS | August 31, 2009 |
| K090987 | VASCUTEK BRANCHED GELWEAVE | June 19, 2009 |
| K081560 | VASCUTEK CANNULA GRAFT, MODEL CGS2008S | February 10, 2009 |
| K070323 | TEMPORARY LIMB SALVAGE SHUNT | February 15, 2007 |
| K060142 | VASCUTEK GELWEAVE SIENA COLLARED ANTEFLO AND PLEXUS WITH RADIOPAQUE MARKERS | February 7, 2006 |
| K043552 | VASCUTEK PTFE SUPPORTED EPTFE VASCULAR PROSTHESES | January 5, 2005 |
| K041528 | MODIFICATION TO EPTFE GRAFT | September 14, 2004 |
| K040829 | GELWEAVE ANTE-FLO WITH COLLAR AND GELWEAVE 4 BRANCH PLEXUS WITH COLLAR | May 20, 2004 |
| K034010 | GELSOFT PLUS ERS | February 19, 2004 |
| K030999 | EPTFE VASCULAR PROSTHESIS; SEALPTFE | April 9, 2003 |
| K964959 | VASCUTEK TWILLWEAVE VASCULAR GRAFT | March 10, 1997 |
| K963611 | VASCUTEK CARDIOVASCULAR FABRIC: VASCUTEK GELSEAL PATCH,VASCUTEK GELSOFT PATCH,VASCUTEK THIN WALL CAR | November 21, 1996 |