Boston Scientific Corporation recalls EkoSonic Kit 106cm, 12cm TZ The EkoSonic Endovascular Device is packaged as a kit that includes both the USC and IC components.…
Product may be mislabeled.
Read the official notice →- Date
- 2022-08-10
- Country
- United States
- Brand
- Boston Scientific
- Product
- EkoSonic Kit 106cm, 12cm TZ The EkoSonic Endovascular Device is packaged as a kit that includes both the USC and IC components. They are…
- Classification
- Class II
- Units
- US distribution only - CA, CT, GA, IA, IL, IN, NY, OH, TX, WY
- 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 Details may be shortened or out of date; the official notice is the authoritative source.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 Boston Scientific recalls
- 2022-11-09
USBoston Scientific Corporation recalls EKOS Control Unit 4.0 console, a component of the EKOS Control System 4.0, which is a component of the EkoSonic Endovascular System.
Consoles were shipped without an instruction for use (IFU) or with the incorrect IFU.
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There is potential for unanticipated software anomalies to occur when using the Model 2868 Application loaded on the 3120 ZOOM LATITUTDE programmer when communicating with certain Boston Scientific transvenous…
- 2022-08-31
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Boston Scientific Corporation recalls Boston Scientific Guider Softip XF, 40 XF, 8F, Guide Catheter, REF H965100440
The impacted products were distributed with an MPXF tip curve shape instead of the 40XF tip curve shape for the Guider/40XF/8FR/90CM guide catheter.
FDA · DeviceBoston Scientific CorporationInternational distribution in the countries of Greece, France, Germany, Italy,…Official notice → - 2022-07-27
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Boston Scientific Corporation recalls GreenLight HPSEA Laser Fibers, UPN 0010-2092
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Boston Scientific Corporation recalls EXALT Model D Single- Use Duodenoscope (Box 2) UPN: M00542421 Intended Use: sterile, single-use, flexible video duodenoscope…
Updated Instructions for Use (IFU) for EXALT Model D Single-Use Duodenoscope highlight the known risk of perforation and provide best clinical practices related to insertion, advancement, and removal of this device.
FDA · DeviceBoston Scientific CorporationWorldwide distribution - US Nationwide and the countries of Australia,…Official notice → - 2022-05-04
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Boston Scientific Corporation recalls SpaceOAR System, UPN SO-1010, SO-2101, SO-3101, and SO-4101. Used to temporarily position the anterior rectal wall away from the…
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Other drugs & medical recalls in the United States
- 2022-08-10
- US
St. Jude Medical, Cardiac Rhythm Management Division recalls Merlin PCS 3650 programmer Model 3330 software
There is a potential for programmer software (Merlin PCS) and remote monitoring software application (Merlin.net) to display overestimated predicted battery longevity for certain pacemakers.
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Dental Choice Holding Llc recalls CustMbite, Model Number CBT-SRS-UL
The device was marketed and sold in the US without FDA clearance.
- US
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Intuitive Surgical, Inc. recalls The E-100 Generator (PN 374848-09) is a bipolar electrosurgical unit (ESU) designed to be used with the da Vinci Xi and X systems. The…
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Medtronic Inc recalls Medline Sprinter OTW, Model/Catalog Number SPR2512W; The Sprinter Over-the-Wire balloon dilatation catheter has a coaxial shaft with a…
Luer has balloon diameter printed as "2.25mmx12mm" instead of the correct diameter, "2.5mmx12mm" as reflected on the product outer packaging.
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Aesculap Implant Systems LLC recalls PRESTIGE RETRACTION GRASPER, W/PORT DUAL ACTION, ROTATING 5mm DIAM., 36cm LENGTH. Product Code 8361-10
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