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…
Read the official notice →- Date
- 2025-03-12
- Country
- United States
- Brand
- Bard Peripheral Vascular
- Product
- 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 x 85…
- Classification
- Class I
- Units
- US Nationwide Distribution: NY, VA, KY, IN, OR, FL, MD, NJ, LA, CO, PR, PA,…
- 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 Details may be shortened or out of date; the official notice is the authoritative source.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.
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- 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
- 2026-02-25
USBard 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 → - 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 →
Other drugs & medical recalls in the United States
- 2025-03-12
- US
Medimaps Group recalls Brand Name: TBS Osteo Product Name: TBS iNsight Model/Catalog Number: TBS iNsight v3.x / pn: OS-TBSi Software Version: V3.x: (1) V3.1.2,…
Potential variability in calculations from fast array scans compared to array scans when operating on Hologic Horizon machines.
FDA · DeviceMedimaps GroupDomestic: AL, AZ, CA, CO, DE, FL, IL, LA, MA, MD, MI, MN, MO, MS, NC, NM, NY,…Official notice → - US
Beckman Coulter, Inc. recalls Access Erythropoietin (EPO), Catalog Number - A16364 a glycoprotein (~30,400 Daltons) produced primarily by the kidney, is the principal…
Affected lot (439363) exhibited a negative dose drop of -22% with native patient samples compared to alternate reagent lots. Patient samples tested with the affected lot may demonstrate repeatable falsely decreased…
FDA · DeviceBeckman Coulter, Inc.Domestic distribution to AL AR AZ CA CT FL ID IL IN KS MA MI NC NE NJ NY OH OR…Official notice → - US
Micro Therapeutics, Inc. recalls Medtronic Pipeline Vantage Embolization Device with Shield Technology, REF: PED3-021-350-16, PED3-021-250-14, PED3-021-350-20,…
Use of embolization device with diameters greater-than-or-equal-to 4mm may lead to incomplete wall apposition and/or braid deformation (fish-mouthing/braid narrowing/braid collapse) noted during procedure and…
FDA · DeviceMicro Therapeutics, Inc.Worldwide distribution: US (nationwide): PR, OK, CA, MD, FL, NY, WA, MI, AL,…Official notice → - US
Biosense Webster, Inc. recalls VARIPULSE Bi-Directional Ablation Catheter REF D141201. The Field Catheter is indicated for use in catheter based cardiac…
Due to an observed trend of neurovascular events
FDA · DeviceBiosense Webster, Inc.Worldwide distribution; US states of AR, CA, CO, KS, LA, MA, MO, NY, OH and…Official notice → - US
Zydus Pharmaceuticals (USA) Inc recalls Nelarabine Injection, 250mg/50mL, (5mg/mL), packaged in: a) 50 mL Single-Dose Vial, NDC 70710-1839-1; b) 6 x 50 mL Single-Dose…
Failed Impurities/Degradation Specifications
- US
Safecor Health, LLC recalls Ergocalciferol - Vitamin D Supplement - 10 mcg (400 Units) per 0.05 mL Oral Syringe, Delivers: 0.05 mL Oral Solution, Mfg by: Westminster,…
Defective Delivery System: Leakage observed after oral solution was repackaged into unit-dose syringes.