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…
Read the official notice →- Date
- 2024-11-20
- Country
- United States
- Brand
- Bard Peripheral Vascular
- Product
- The EVSRF catheter is a sterile, single-use disposable medical device for endovenous radiofrequency ablation, a procedure in which a…
- Classification
- Class II
- Units
- Worldwide - U.S. Nationwide distribution including in the states of AK, AL,…
- Category
- Drugs & medical
- Source
- FDA · Device
Copied automatically from the US Food and Drug Administration. Details may be shortened or out of date; the official notice is the authoritative source. Disclaimer
What to do
- Check the product name, strength and lot number against the official notice.
- Do not stop a prescribed medicine without talking to your doctor or pharmacist first.
- Ask the pharmacy or supplier about a replacement or refund.
General guidance from Recall Atlas. The official notice from the US Food and Drug Administration has the exact models, batch codes and remedy, and it takes priority.
More Bard Peripheral Vascular recalls
- 2025-10-08
USBard 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 → - 2024-10-02
- 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…
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Other drugs & medical recalls in the United States
- 2024-11-20
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Getinge Usa Sales Inc recalls MEERA CL mobile operating table - Designed for the placement and positioning of the patient immediately before, during and after surgical…
Error code "50037" occurs on the IR-Hand Control when a MEERA-table is controlled, and the table stops the movement. This error may occur sporadically when the MEERA-table is controlled via an IR-Hand Control and may…
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AVID Medical, Inc. recalls Halyard KIT, SHOULDER - Medical convenience kits Model Number: ESJH014-06
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There is a potential for the product to activate without manual input when plugged into a power source or remain active after buttons are released. Unintentional activation of the device may result in localized burns…
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