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Bard Peripheral Vascular Inc FDA Recalls
37 recalls on file across devices, 1 of them Class I and 31 still open. This firm is not matched to a listed company.
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Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.
| Product |
|---|
| Broviac 4.2 Fr Single-Lumen CV Catheter Cutdown Tray with SureCuff Tissue Ingrowth Cuff Cat 60060Class IIDec 12, 2025Due to damage to outer tray that can potentially compromise |
| Safe-T-Centesis 6 Fr Catheter Drainage Tray, REF: PIG1260T,Class IINov 6, 2025Acute drainage catheters, indicated for use in removing flui |
| Venclose digiRF Generators, Model VCRFG1, with software 3.35 designed to identify internal wiring anomalies in the VenclClass IIAug 21, 2025Software version 3.35 of the Venclose digiRF Generator incor |
| Rotarex Atherectomy System and Instructions for Use, BD SET Rotarex: S 6 F x 110 cm, REF: 80236; S 6 F x 135 cm, REF: Class IFeb 5, 2025Atherectomy Catheter eIFU updated to clarify and emphasize p |
| Bard Marquee Disposable Core Biopsy Instrument Kit: BARD MARQUEE KIT 12G X 10 CM, REF: MQK1210; BARD MARQUEE 12G X 10 Class IISep 30, 2024Disposable biopsy instruments were potentially manufactured |
| The EVSRF catheter is a sterile, single-use disposable medical device for endovenous radiofrequency ablation, a procedurClass IISep 4, 2024The Venclose" RF Ablation Catheters may have been manufactur |
| BARD MAGNUM Disposable Core Tissue Biopsy Needle REF: MN1410 MN 1420 MN1610 MN1616 MN1820 MN2010 The Magnum BioClass IIAug 2, 2024Due to possible packaging damage (indentations/cuts) cause b |
| Guidewire 70cm x 1mm (0.038 ) REF 5583705 These accessories are intended for use with Bard 14.5 Fr. Long-Term Dual LuClass IIJul 10, 2024Due to guidewires being manufactured incorrectly with the gu |
| BD Recanalization System, REF: BDRECANSYSTEMClass IINov 14, 2023Recanalization systems may be in a manufacturing mode that a |
| Bard Mission Disposable Core Biopsy Instrument Kit (REF/Name): 1410MSK/ Mission Kit 14G x 10CM; 1416MSK/ Mission Kit 14GClass IINov 8, 2023The internal diameter of the coaxial cannula may be smaller |
| Bard Marquee Disposable Core Biopsy Instrument Kit, REF: MQK2016Class IIAug 10, 2023Diameter mismatch between coaxial and biopsy needle (cutting |
| Bard Mission Disposable Core Biopsy Instrument Kit: REF: 2010MSK, 20G x 10CM; REF: 2016MSK, 20G x 16CMClass IIApr 11, 2023Coaxial cannula internal diameter and length of biopsy instr |
| Bard Mission Disposable Core Biopsy Instrument Kit: 16G x 10CM, REF: 1610MSK; 18G x 16CM, REF: 1816MSKClass IIFeb 28, 2023The external diameter of the biopsy instrument is larger tha |
| Catalog Number / Product Description 0601600 2.7F Broviac CV Catheter Repair Kit 0601610 4.2 Fr Broviac CV Catheter RClass IIJan 4, 2023Due to the adhesive provided within the catheter repair kits |
| The Covera Vascular Covered Stent is a flexible, self-expanding endoprothesis comprised of ePTFE encapsulating a nitinolClass IIDec 22, 2022An increase in the reported complaint rate for inability to |
| REF: PIG1260K, 6Fr, X10, Safe-t-Centesis Catheter drainage Kit, Sterile EO,Class IIApr 22, 2022There is the potential that a 6 Fr Catheter Drainage kit con |
| LUMBAR PUNCTURE DRUG FREE TRAY 22GClass IIJan 20, 2022Due to lumbar puncture tray manometer failure mode of leakin |
| SAFE-T PLUS ATRAUMATIC ADULT LP TRAYClass IIJan 20, 2022Due to lumbar puncture tray manometer failure mode of leakin |
| LUMBAR PUNCTURE TRAY PEDIATRIC 21G 2.5Class IIJan 20, 2022Due to lumbar puncture tray manometer failure mode of leakin |
| Safe-T PLUS Pediatric/Infant Lumbar Puncture Tray, 22 g x 1.5" Spinal Needle with ManometerClass IIJan 20, 2022Due to lumbar puncture tray manometer failure mode of leakin |
| LUMBAR PUNCTURE TRAY ADULT 20G X 3.5 DPClass IIJan 20, 2022Due to lumbar puncture tray manometer failure mode of leakin |
| ADULT LUMBAR PUNCTURE DRUG FREE TRAY 20GClass IIJan 20, 2022Due to lumbar puncture tray manometer failure mode of leakin |
| ATRAUMATIC ADULT LUMBAR PUNCTURE TRAYClass IIJan 20, 2022Due to lumbar puncture tray manometer failure mode of leakin |
| SAFE-T PLUS LUMBAR PUNCTURE TRAY ADULTClass IIJan 20, 2022Due to lumbar puncture tray manometer failure mode of leakin |
| LUMBAR PUNCTURE TRAY ADULT 18G X 3.5Class IIJan 20, 2022Due to lumbar puncture tray manometer failure mode of leakin |
| LUMBAR PUNCTURE TRAY ADULT 22G X3.5 STRLClass IIJan 20, 2022Due to lumbar puncture tray manometer failure mode of leakin |
| SAFE-T PLUS LUMBARPUNCTURE TRAY ADULTClass IIJan 20, 2022Due to lumbar puncture tray manometer failure mode of leakin |
| Catalog # BEK3411, Ecomomy Jamshidi Bone Marrow Biopsy Tray, 11 G X 4"Biopsy/Aspiration needle, sterile, Qty: 10, SingleClass IIAug 24, 2021Due to misbranded products shipped to customers. |
| Catalog # BEK4511, Qty: 10, Ecomomy Jamshidi Bone Marrow Biopsy and Aspiration Tray, 11 G X 4"Biopsy/Aspiration needle, Class IIAug 24, 2021Due to misbranded products shipped to customers. |
| REF TIN3015, 15G x 79 mm Bone Marrow Aspiration/Intraosseous Infusion Needle, For Single Use Only, Sterile EO, UDI: 1088Class IIJul 27, 2021Potential for needle protector to become fully dislodge expo |
| TIN3018 Illinois Bone Marrow Aspiration/Intraosseous Infusion Needle 18G x 79mm TIN3015 Illinois Bone Marrow AspirationClass IIJun 23, 2021Due to complaints received regarding incomplete/open packagi |
| TJM6008 Jamshidi" Crown Bone Marrow Biopsy/Aspiration Needle with Marrow Acquisition Cradle. 8G x 15 cm; TJC3513 JamshiClass IIJun 23, 2021Due to complaints received regarding incomplete/open packagi |
| EJM4011 Jamshidi Evolve" Bone Marrow Biopsy/Aspiration Needle with Specimen Cradle. 11G x 10cmClass IIJun 23, 2021Due to complaints received regarding incomplete/open packagi |
| PowerPort duo M.R.I. Implantable Port, with attachable 9.5F Polurethane Open-Ended Dual-Lumen Venous Catheter, REF 18295Class IIMar 25, 2021Catheters may experience difficulty in flushing, infusion, a |
| PowerPort duo M.R.I. Implantable Port, with attachable 9.5F Polurethane Open-Ended Dual-Lumen Venous Catheter, REF 18295Class IIMar 25, 2021Catheters may experience difficulty in flushing, infusion, a |
| PowerPort duo M.R.I. Implantable Port, with attachable 9.5F Polurethane Open-Ended Dual-Lumen Venous Catheter, REF 58295Class IIMar 25, 2021Catheters may experience difficulty in flushing, infusion, a |
| BARD MARQUEE Disposable Core Biopsy Instruments XX.Xcm, XX.Xcm, XXg x XXcm REF XXXXXXX Note - for definition of the Class IIJan 14, 2021Due to the Penetration Depth Switch used to select the desir |