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…
Read the official notice →- Date
- 2022-04-20
- Country
- United States
- Brand
- Volcano
- Product
- MM-TSM (Touch Screen Module/Secondary Controller/Bedside Controller), Part Numbers: 300002018101, 300002018102, used with IntraSight…
- Classification
- Class III
- Units
- US: AZ, IL, NV, MI, FL, NC, AK, PA, WI, MN, CA, AR, NJ, TX, OR, NM, SD, CO,…
- 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 Details may be shortened or out of date; the official notice is the authoritative source.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
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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
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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
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Volcano Corp recalls Philips OmniWire Pressure guide wire REF 89185J PN 300000252891
Due to a potential failed sterilization process.
- 2022-04-20
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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
- 2022-04-20
- US
Luminex Corporation recalls Verigene Processor SP, Model Numbers: 10-0000-07 and 10-0000-07-R
Two of three complaints were initiated due to the customers repeatedly obtaining No Call results on the Processor SPs in question.
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GE Healthcare, LLC recalls MUSE Cardiology Information System, Model Numbers: a) 3101011-040, b) 3101010-401, c) 3101010-009, d) 3101010-008
Two scenarios may cause edits to measurements and diagnosis statements can be lost after a test is Signed in the MUSE NX web client.
FDA · DeviceGE Healthcare, LLCUS and Australia, Austria, Bahrain, Belgium, Brazil, Canada, Denmark, England,…Official notice → - US
Sensory Medical Inc recalls Cub 2 Enclosed Bed Canopy System
Due potential misuse of the product, firm is updating warnings and precautions booklet for products distributed before December 16, 2021.
FDA · DeviceSensory Medical IncU.S. Nationwide distribution to states including: AK, AZ, CA, CO, CT, DE, FL,…Official notice → - US
Boston Scientific Corporation recalls ROTAWIRE Drive and wireClip Torquer, ROTAWIRE Drive Floppy
Pouch seals may be open, compromising sterility.
FDA · DeviceBoston Scientific CorporationDistribution in the US and territories, Japan, and CanadaOfficial notice → - US
Nextremity Solutions recalls Nextra Hammertoe Correction System 3.5 Middle and 3.2 Proximal Saw Cut SKU: NX-3532K-SC Orthopedic surgical instrument
Proximal end of the driver is oversized in varying degrees, making it difficult to fully connect with and remove from the proximal Nextra implant, causing delay in surgery
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Integra LifeSciences Corp. recalls Integra Universal Flexible Arm part number REF 1362275
Excess force used to tighten the Universal Flexible Arm can cause the internal cable to break at the tip, resulting in an unusable condition.
FDA · DeviceIntegra LifeSciences Corp.US Nationwide Distribution: AL, AZ, FL, GA, IL, MA, MD, NY, OH, OR, PA, TXOfficial notice →