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…
Read the official notice →- Date
- 2022-04-13
- Country
- United States
- Brand
- Volcano
- Product
- SyncVision Systems, Model: 400-0100.10, PN: 30000485688x, with software version 4.2.x
- Classification
- Class II
- Units
- US: WI, CA, CO, MO, ID, DC, LA, VA, KS, OK, GA, KY, IL, AZ, NY, IN, FL, TX,…
- 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 Details may be shortened or out of date; the official notice is the authoritative source.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 →- 2025-08-06
- US
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…
FDA · DeviceVolcano CorpWorldwide distribution - US Nationwide distribution including in the states of…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 →
Other drugs & medical recalls in the United States
- 2022-04-13
- US
Abbott Laboratories recalls ARCHITECT STAT Myoglobin Calibrators, RES 2K43-01 The ARCHITECT STAT Myoglobin Calibrators are for the calibration of the ARCHITECT…
This calibrator lot did not meet acceptance criteria during ongoing stability testing. When a calibration is performed with this lot, controls may exceed the specified range in the Instructions for Use (IFU).
FDA · DeviceAbbott LaboratoriesWorldwide Distribution: US (nationwide) and OUS (foreign) including countries…Official notice → - US
Brius Technologies Inc. recalls Brius Patient Specific Brackets (components in a set of custom metal orthodontic devices); BRIUS , RX Only, Non-Sterile, Custom Made…
Pontics, brackets, and customized orthodontic appliances were sold and distributed prior to completing the standard design control process, being documented, and released.
- US
Maquet Cardiovascular, LLC recalls Ultima Activator II Reusable Drive Mechanism, part # C-UA-5001. Labeled REF UA-5001.
Potential for corrosion on the pins of the Ultima Activator II Reusable Drive Mechanism. Harms may include allergic reaction, metal toxicity, and other delayed responses.
FDA · DeviceMaquet Cardiovascular, LLCWorldwide - United States (AL, AZ, CA, FL, IL, KY, LA, MO, MT, NM, OH, PA, TX,…Official notice → - US
Abbott Molecular, Inc. recalls Alinity m HBV AMP Kit (US and CE)
There is a potential for misquantitation high results for negative samples.
FDA · DeviceAbbott Molecular, Inc.US consignees - AZ, CA, IL, IN, MA, MI, MO, NH, NJ, NY, OH, SD, TX, and VA OUS…Official notice → - US
Abbott Molecular, Inc. recalls Alinity m HBV Application Specification File (US and CE)
There is a potential for misquantitation high results of negative samples.
FDA · DeviceAbbott Molecular, Inc.US consignees - AZ, CA, IL, IN, MA, MI, MO, NH, NJ, NY, OH, SD, TX, and VA OUS…Official notice → - US
Philips North America LLC recalls Philips, REF M5071A, Adult. Smart PADS CARTRIDGE, 8+ years FOR USE WITH HEARSTART HS1 DEFIBRILLATORS
There is a potential for AED pads to experience gel separation from the foam/tin backing when peeled from the plastic liner. The gel may fold onto itself resulting in reduced surface area or gel on the pad, or it may…
FDA · DevicePhilips North America LLCWorldwide distribution. US Nationwide including Puerto Rico and Guam, Germany,…Official notice →