Bard Peripheral Vascular recalls
20 official recalls and safety alerts involving Bard Peripheral Vascular since 2021-10, from FDA · Device. Newest first. Check the official notice for exact models and batch codes.
This list only includes recalls Recall Atlas has collected since 2021-10. A product not listed here may still be affected; check with Bard Peripheral Vascular or the relevant agency.
- 2026-10-07
USBard Peripheral Vascular Inc recalls EnCor EnCompass Breast Biopsy and Tissue Removal System Console (model number: ENCPCONSOLE) and Driver (model number: ENCPDRIVER)…
Breast biopsy and tissue removal system may experience the following errors: 1) Probe calibration and /or handheld driver failure (code HH01-00020009) , 2) Pressure sensor (code E01-0054000E), which prompts the user to…
FDA · DeviceBard Peripheral Vascular IncUS Nationwide distribution in the states of KS, SC, CA, TX, GA, NC, PA, SC,…Official notice →- 2026-02-25
- US
Bard Peripheral Vascular Inc recalls Broviac 4.2 Fr Single-Lumen CV Catheter Cutdown Tray with SureCuff Tissue Ingrowth Cuff Cat 60060
Due to damage to outer tray that can potentially compromise the sterile barrier
FDA · DeviceBard Peripheral Vascular IncWorldwide - U.S. Nationwide distribution including in the states of AL, AR,…Official notice → - 2025-12-17
- US
Bard Peripheral Vascular Inc recalls Safe-T-Centesis 6 Fr Catheter Drainage Tray, REF: PIG1260T,
Acute drainage catheters, indicated for use in removing fluid during acute drainage/aspiration procedure, manufactured with safety indicators that erroneously show catheter in sharp position when catheter is in blunt…
FDA · DeviceBard Peripheral Vascular IncUS Nationwide distribution in the states of CA, MN, IN, MI, LA.Official notice → - 2025-10-08
- US
Bard Peripheral Vascular Inc recalls Venclose digiRF Generators, Model VCRFG1, with software 3.35 designed to identify internal wiring anomalies in the Venclose EVSRF…
Software version 3.35 of the Venclose digiRF Generator incorporates a catheter verification feature specifically designed to detect internal wiring anomalies in Venclose EVSRF Ablation Catheters prior to clinical use.…
FDA · DeviceBard Peripheral Vascular IncWorldwide - US Nationwide distribution including in the states of NJ, NY, FL,…Official notice → - 2025-03-12
- US
Bard Peripheral Vascular Inc recalls 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: 80237; S 8 F…
Atherectomy Catheter eIFU updated to clarify and emphasize procedural steps intended to reduce the likelihood of catheter breakage events. Catheter has an outer cylinder connected to a rotating helix, which could…
FDA · DeviceBard Peripheral Vascular IncUS Nationwide Distribution: NY, VA, KY, IN, OR, FL, MD, NJ, LA, CO, PR, PA,…Official notice → - 2024-11-27
- US
Bard Peripheral Vascular Inc recalls Bard Marquee Disposable Core Biopsy Instrument Kit: BARD MARQUEE KIT 12G X 10 CM, REF: MQK1210; BARD MARQUEE 12G X 10 CM, REF:…
Disposable biopsy instruments were potentially manufactured missing the backend notch retention feature on the needle that results in inadequate securing of the needle inside the device, which could lead to needle…
FDA · DeviceBard Peripheral Vascular IncWorldwide - US Nationwide including in the states of WA, LA, MN, PA, UT, SC,…Official notice → - 2024-11-20
- US
Bard Peripheral Vascular Inc recalls The EVSRF catheter is a sterile, single-use disposable medical device for endovenous radiofrequency ablation, a procedure in which a…
The Venclose" RF Ablation Catheters may have been manufactured with internal wiring error. The red and yellow signal wires were soldered on swapped ports of the catheter PCB. This error in wire configuration would lead…
FDA · DeviceBard Peripheral Vascular IncWorldwide - U.S. Nationwide distribution including in the states of AK, AL,…Official notice → - 2024-10-02
- US
Bard Peripheral Vascular Inc recalls BARD MAGNUM Disposable Core Tissue Biopsy Needle REF: MN1410 MN 1420 MN1610 MN1616 MN1820 MN2010 The Magnum Biopsy System…
Due to possible packaging damage (indentations/cuts) cause by manufacturing process. As a result of the packaging damage, may cause the sterile barrier to be compromised.
FDA · DeviceBard Peripheral Vascular IncWorldwide - U.S. Nationwide distribution in the Puerto Rico and the countries…Official notice → - 2024-09-18
- US
Bard Peripheral Vascular Inc recalls Guidewire 70cm x 1mm (0.038 ) REF 5583705 These accessories are intended for use with Bard 14.5 Fr. Long-Term Dual Lumen…
Due to guidewires being manufactured incorrectly with the guidewires being mis-assembled within the hoop such that the proximal (stiff) end of the guidewire is located at the distal end of the hoop. Injury could occur…
FDA · DeviceBard Peripheral Vascular IncWorldwide - U.S. Nationwide distribution in the states of OH, TX, and WV. The…Official notice → - 2024-01-17
- US
Bard Peripheral Vascular Inc recalls BD Recanalization System, REF: BDRECANSYSTEM
Recanalization systems may be in a manufacturing mode that allows the system to continuously run without the typical 30 second pauses, and 4-minute warning/5-minute restart required messages to indicate the ten-minute…
FDA · DeviceBard Peripheral Vascular IncUS: CA, OH, PA, NY, TX, NJ, MS, IL, GA, AL, AZ, NC, NV, PR, IN, MA, WI, KS,…Official notice → - US
Bard Peripheral Vascular Inc recalls Bard Mission Disposable Core Biopsy Instrument Kit (REF/Name): 1410MSK/ Mission Kit 14G x 10CM; 1416MSK/ Mission Kit 14G x 16CM;…
The internal diameter of the coaxial cannula may be smaller or larger than the external diameter of the biopsy needle, and the length of the cannula may exceed the stated length on the label. As a result, the biopsy…
FDA · DeviceBard Peripheral Vascular IncWorldwide - US Nationwide distribution including in the states of PR, IL, MA,…Official notice → - 2023-10-11
- US
Bard Peripheral Vascular Inc recalls Bard Marquee Disposable Core Biopsy Instrument Kit, REF: MQK2016
Diameter mismatch between coaxial and biopsy needle (cutting cannula) in disposable core biopsy instrument kits, where the coaxial cannula inner diameter prohibits the biopsy needle (cutting cannula) from properly…
FDA · DeviceBard Peripheral Vascular IncWorldwide - US Nationwide distribution in the states of PR, CO, TX, CA, WA,…Official notice → - 2023-05-17
- US
Bard Peripheral Vascular Inc recalls Bard Mission Disposable Core Biopsy Instrument Kit: REF: 2010MSK, 20G x 10CM; REF: 2016MSK, 20G x 16CM
Coaxial cannula internal diameter and length of biopsy instruments exceed the external diameter and length of the biopsy needle, prohibiting the biopsy needle from properly fitting into the coaxial cannula and…
FDA · DeviceBard Peripheral Vascular IncUS Nationwide Distribution: PR, AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA,…Official notice → - 2023-03-22
- US
Bard Peripheral Vascular Inc recalls Bard Mission Disposable Core Biopsy Instrument Kit: 16G x 10CM, REF: 1610MSK; 18G x 16CM, REF: 1816MSK
The external diameter of the biopsy instrument is larger than the internal diameter of the coaxial needle, which could lead to: 1) Procedural delay, 2) Requirement of an additional device, 3), Needle tip breakage, if…
FDA · DeviceBard Peripheral Vascular IncWorldwide Distribution: US (Nationwide) includes states of: FL, MD, OH, CO,…Official notice → - 2023-02-15
- US
Bard Peripheral Vascular Inc recalls The Covera Vascular Covered Stent is a flexible, self-expanding endoprothesis comprised of ePTFE encapsulating a nitinol stent…
An increase in the reported complaint rate for inability to deploy was identified and related to poor slide block bonding.
FDA · DeviceBard Peripheral Vascular IncWorldwide - U.S. Nationwide distribution including in the states of AK, AL,…Official notice → - 2023-02-08
- US
Bard Peripheral Vascular Inc recalls Catalog Number / Product Description 0601600 2.7F Broviac CV Catheter Repair Kit 0601610 4.2 Fr Broviac CV Catheter Repair Kit…
Due to the adhesive provided within the catheter repair kits maybe hardened/coagulated (unusable).
FDA · DeviceBard Peripheral Vascular IncWorldwide Distribution: U.S.(nationwide): AK, AL, AR, AZ, CA, CO, CT, DC, DE,…Official notice → - 2022-06-29
- US
Bard Peripheral Vascular Inc recalls REF: PIG1260K, 6Fr, X10, Safe-t-Centesis Catheter drainage Kit, Sterile EO,
There is the potential that a 6 Fr Catheter Drainage kit contains an 8 Fr needle instead of a 6 Fr needle. They can be used in conjunction with the following drainage methods: Universal extension set and drainage bag,…
FDA · DeviceBard Peripheral Vascular IncWorldwide distribution - US Nationwide distribution in the states of MS, NC,…Official notice → - 2022-03-23
- US
Bard Peripheral Vascular Inc recalls LUMBAR PUNCTURE TRAY PEDIATRIC 21G 2.5
Due to lumbar puncture tray manometer failure mode of leaking and mating issues.
FDA · DeviceBard Peripheral Vascular IncU.S. Nationwide Distribution: AK, AL, AR, AZ, CA, CO, CT, DC, FL, GA, HI, IA,…Official notice → - 2021-10-27
- US
Bard Peripheral Vascular Inc recalls Catalog # BEK4511, Qty: 10, Ecomomy Jamshidi Bone Marrow Biopsy and Aspiration Tray, 11 G X 4"Biopsy/Aspiration needle, 15 G…
Due to misbranded products shipped to customers.
FDA · DeviceBard Peripheral Vascular IncU.S. Distribution: CA, GA,HI, IL, IN, LA, MO, MS, NC, OH, PA, PR, TX, UT, VA,…Official notice → - 2021-10-13
- US
Bard Peripheral Vascular Inc recalls REF TIN3015, 15G x 79 mm Bone Marrow Aspiration/Intraosseous Infusion Needle, For Single Use Only, Sterile EO, UDI: 10885403043796
Potential for needle protector to become fully dislodge exposing infusion needle which could result in needle stick.
FDA · DeviceBard Peripheral Vascular IncWorldwide distribution - US Nationwide distribution in the states of AL, AR,…Official notice →