Bard Peripheral Vascular Inc
FDA Regulatory Profile
Bard Peripheral Vascular Inc appears in FDA public data with 139 recalls — including 5 Class I (most serious) —, 38 510(k) clearances, 12 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-1367-2026, Class II) was initiated on December 12, 2025. Its most recent 510(k) clearance was granted on February 4, 2026.
Summary
- Total Recalls
- 139 (5 Class I)
- 510(k) Clearances
- 38
- Inspections
- 12
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-1367-2026 | Class II | Broviac 4.2 Fr Single-Lumen CV Catheter Cutdown Tray with SureCuff Tissue Ingrowth Cuff Cat 60060 | December 12, 2025 |
| Z-0887-2026 | Class II | Safe-T-Centesis 6 Fr Catheter Drainage Tray, REF: PIG1260T, | November 6, 2025 |
| Z-2638-2025 | Class II | Venclose digiRF Generators, Model VCRFG1, with software 3.35 designed to identify internal wiring an | August 21, 2025 |
| Z-1244-2025 | Class I | Rotarex Atherectomy System and Instructions for Use, BD SET Rotarex: S 6 F x 110 cm, REF: 80236; S | February 5, 2025 |
| Z-0467-2025 | Class II | Bard Marquee Disposable Core Biopsy Instrument Kit: BARD MARQUEE KIT 12G X 10 CM, REF: MQK1210; BA | September 30, 2024 |
| Z-0371-2025 | Class II | The EVSRF catheter is a sterile, single-use disposable medical device for endovenous radiofrequency | September 4, 2024 |
| Z-3206-2024 | Class II | BARD MAGNUM Disposable Core Tissue Biopsy Needle REF: MN1410 MN 1420 MN1610 MN1616 MN1820 MN20 | August 2, 2024 |
| Z-3062-2024 | Class II | Guidewire 70cm x 1mm (0.038 ) REF 5583705 These accessories are intended for use with Bard 14.5 F | July 10, 2024 |
| Z-0676-2024 | Class II | BD Recanalization System, REF: BDRECANSYSTEM | November 14, 2023 |
| Z-0643-2024 | Class II | Bard Mission Disposable Core Biopsy Instrument Kit (REF/Name): 1410MSK/ Mission Kit 14G x 10CM; 1416 | November 8, 2023 |
| Z-0027-2024 | Class II | Bard Marquee Disposable Core Biopsy Instrument Kit, REF: MQK2016 | August 10, 2023 |
| Z-1564-2023 | Class II | Bard Mission Disposable Core Biopsy Instrument Kit: REF: 2010MSK, 20G x 10CM; REF: 2016MSK, 20G x 16 | April 11, 2023 |
| Z-1260-2023 | Class II | Bard Mission Disposable Core Biopsy Instrument Kit: 16G x 10CM, REF: 1610MSK; 18G x 16CM, REF: 1816M | February 28, 2023 |
| Z-1051-2023 | Class II | Catalog Number / Product Description 0601600 2.7F Broviac CV Catheter Repair Kit 0601610 4.2 Fr B | January 4, 2023 |
| Z-1108-2023 | Class II | The Covera Vascular Covered Stent is a flexible, self-expanding endoprothesis comprised of ePTFE enc | December 22, 2022 |
| Z-1273-2022 | Class II | REF: PIG1260K, 6Fr, X10, Safe-t-Centesis Catheter drainage Kit, Sterile EO, | April 22, 2022 |
| Z-0795-2022 | Class II | LUMBAR PUNCTURE TRAY ADULT 18G X 3.5 | January 20, 2022 |
| Z-0792-2022 | Class II | LUMBAR PUNCTURE TRAY ADULT 20G X 3.5 DP | January 20, 2022 |
| Z-0798-2022 | Class II | ATRAUMATIC ADULT LUMBAR PUNCTURE TRAY | January 20, 2022 |
| Z-0790-2022 | Class II | Safe-T PLUS Pediatric/Infant Lumbar Puncture Tray, 22 g x 1.5" Spinal Needle with Manometer | January 20, 2022 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K260012 | UltraScore Focused Force PTA Balloon | February 4, 2026 |
| K252681 | EnCor EnCompass Breast Biopsy and Tissue Removal System | December 12, 2025 |
| K250032 | Marquee Disposable Core Biopsy Instrument and Instrument Kit | July 10, 2025 |
| K250219 | Dorado PTA Balloon Dilatation Catheter | June 17, 2025 |
| K243642 | UltraCor Twirl Breast Tissue Marker | March 24, 2025 |
| K242757 | Rotarex Atherectomy System | January 30, 2025 |
| K241946 | PeritX 1L Drainage Kit (90-1010); PeritX 2L Drainage Kit (90-2010); PeritX Peritoneal Catheter Ki | December 6, 2024 |
| K232737 | PowerPort ClearVUE Slim ECG Enabled Implantable Port; PowerPort ClearVUE isp ECG Enabled Implant | December 8, 2023 |
| K221440 | Liverty TIPS Access Set | May 31, 2022 |
| K213896 | BD Trek Powered Bone Biopsy System | March 30, 2022 |
| K211933 | EleVation Breast Biopsy System | July 15, 2021 |
| K211410 | GlidePath 13F Long-Term Hemodialysis Catheter | June 4, 2021 |
| K192948 | EleVation Breast Biopsy Driver, EleVation Breast Biopsy Probe - 10G, EleVation Breast Biopsy Probe - | November 7, 2019 |
| K192318 | Ultraverse 014 and 018 PTA Balloon Dilatation Catheters | October 3, 2019 |
| K180061 | UltraCor Twirl Breast Tissue Marker | March 9, 2018 |
| K171953 | Bard Mission Disposable Core Biopsy Instrument | September 14, 2017 |
| K163420 | UltraScore Focused Force PTA Balloon | June 14, 2017 |
| K161986 | SIDEKICK and USHER Support Catheters | August 4, 2016 |
| K152510 | UltraCor Twirl Breast Tissue Marker | May 13, 2016 |
| K142261 | Ultraverse 035 PTA Balloon Dilatation Catheter | September 24, 2014 |