Volcano Corp recalls Volcano Visions Digital IVUS Catheter: PV.014P (Platinum), REF:85910P; PV.014P RX, REF: 014R; and PV.018, REF: 86700, 86700J used with…
Reports of IVUS catheter and guide wire entanglement during radial-to-peripheral procedures, due to catheter use without appropriate sheath and/or guide catheter, which may require further intervention, such as…
Read the official notice →- Date
- 2025-08-06
- Country
- United States
- Brand
- Volcano
- Product
- Volcano Visions Digital IVUS Catheter: PV.014P (Platinum), REF:85910P; PV.014P RX, REF: 014R; and PV.018, REF: 86700, 86700J used with…
- Classification
- Class II
- Units
- Worldwide distribution - US Nationwide distribution including in the states of…
- 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 Details may be shortened or out of date; the official notice is the authoritative source.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 Volcano recalls
- 2026-10-07
USVolcano Corp recalls Philips IntraSight Plus REF: 797423 and 797417 100-120v-220-240v,50/60hZ, 1000 VA
Software system may associate image data from one patient with another patient's record, potentially resulting in incorrect diagnosis or treatment.
FDA · DeviceVolcano CorpWorldwide - US Nationwide distribution in the states of MA, MN, TX, AL, GA, CA…Official notice →- 2022-07-06
- US
Volcano Corp recalls Volcano Visions PV. 035 Digital IVUS Catheter REF 88901, PN: 300005384002 Rx Only, Sterile EO, CE 2797
Digital IVUS catheter instructions for use ( IFU) do not contain contrainidications
FDA · DeviceVolcano CorpWorldwide distribution - US Nationwide distribution in the states of NY, CA,…Official notice → - 2022-06-22
- US
Volcano Corp recalls Philips OmniWire Pressure guide wire REF 89185J PN 300000252891
Due to a potential failed sterilization process.
- 2022-04-20
- US
Volcano Corp recalls MM-TSM (Touch Screen Module/Secondary Controller/Bedside Controller), Part Numbers: 300002018101, 300002018102, used with IntraSight…
Multi-Modality Touch Screen Modules (MM-TSM), used with integrated IVUS systems, may crack, or become damaged, which may affect their usability. They could become non-functional. Therefore, bottom protective beams will…
FDA · DeviceVolcano CorpUS: AZ, IL, NV, MI, FL, NC, AK, PA, WI, MN, CA, AR, NJ, TX, OR, NM, SD, CO,…Official notice → - US
Volcano Corp recalls IntraSight Mobile IVUS Systems, Model: 797415, Part numbers: 300002018101, 300002018102
Multi-Modality Touch Screen Modules (MM-TSM), which are bedside/secondary control units, used as part of Mobile IVUS systems, are missing the following labeling information: Unique Device Identifier, Legal Manufacturer…
FDA · DeviceVolcano CorpUS: CO, GA, MA, TX, AZ, NY, PA, CA, FL, MO, OR, MD, NC, TN OUS: JP, DE, GB,…Official notice → - 2022-04-13
- US
Volcano Corporation recalls SyncVision Systems, Model: 400-0100.10, PN: 30000485688x, with software version 4.2.x
If FFR measurement(s) are made prior to an iFR/FFR co-registration/pullback in the same procedural session, this could result in incorrect iFR/FFR Co-Registration results to be displayed, that may cause users to…
FDA · DeviceVolcano CorporationUS: WI, CA, CO, MO, ID, DC, LA, VA, KS, OK, GA, KY, IL, AZ, NY, IN, FL, TX,…Official notice →
Other drugs & medical recalls in the United States
- 2025-08-06
- US
Siemens Healthcare Diagnostics Inc recalls RAPIDPoint 500 Systems Wash/Waste Cartridge (4 Pack). Material Number: 10329097.
Siemens Healthcare Diagnostics is recalling the RAPIDPoint 500 Systems Wash/Waste Cartridge Lot WW/08925 due to a manufacturing error causing positive and negative bias in Ionized Calcium, Potassium, pH, Chloride,…
FDA · DeviceSiemens Healthcare Diagnostics Incworldwide distribution - US Nationwide and the countries of Canada, Chile,…Official notice → - US
Remel, Inc recalls Blood Agar,5% Sheep Blood 100/PK, Product Number R01202
The products may contain surface and subsurface contamination of Listeria monocytogenes.
- US
Osteotec Limited recalls Brand Name: Osteotec Product Name: Osteotec Silicone Finger Implant Model/Catalog Number: OSTF-3 (Sz. 3), OSTF-4 (Sz. 4), OSTF-5 (Sz. 5)…
There is the potential that the silicone implant may contain foreign material
- US
INSTITUT GEORGES LOPEZ recalls Brand Name: Celsior Cold Storage Solution Product Name: Celsior Cold Storage Solution Model/Catalog Number: 533682 Product Description: In…
The potential for risk of microbiological contamination of products due to inability to ensure sterility assurance throughout aseptic manufacturing.
FDA · DeviceINSTITUT GEORGES LOPEZInternational distribution to the country of France.Official notice → - US
FUJIFILM Healthcare Americas Corporation recalls ASPRIRE Cristalle Mammography System (cleared under K212873) installed with the ASPIRE Cristalle Digital Breast…
Devices had an unapproved slabbing software function enabled for use.
FDA · DeviceFUJIFILM Healthcare Americas CorporationWorldwide distribution - US Nationwide and the countries of Canada, Chile,…Official notice → - US
Philips North America recalls Ingenia Elition X Model Numbers (REF): (1) 781358, (2) 782107, (3) 782119, (4) 782136, (5) 782151 (China ONLY);
The potential for component failures in the Gradient Coil of the affected MR systems may act as a heat source with a potential to produce smoke and/or fire.
FDA · DevicePhilips North AmericaWorldwide distribution - US Nationwide and the countries of Albania, Algeria,…Official notice →