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Moderate riskFDA DeviceClass II

Boston Scientific TCD electrodes recalled for possible contamination

Some TCD radiofrequency electrodes may have small cut marks on the Tyvek side of the sterile pouch. If the sterile barrier is compromised and the devices are used, microbial or other foreign material could enter patient tissue, which may lead to infection, pain, inflammation, allergic reaction, or the need for more medical or surgical treatment. No injuries have been reported.

From the FDA notice · Read the official notice ↗ · All Boston Scientific recalls

What to do

  1. Do not use affected electrodes. Set aside any pouch with a cut mark or matching lot.
  2. Affected models are TCD-5, TCD-10, TCD-15, TCD-10-3M and TCD-15-3M, including their multi-pack (-P) versions. Check the lot numbers in the notice.
  3. The notice doesn't say how to return or replace the devices. Contact Boston Scientific Neuromodulation Corporation for instructions.
Official notice ↗

Is yours affected?

Compare your label or packaging with the recalled product.

Product
TCD Electrodes (Description/REF(Inner/Outer)): TCD Electrode, Multi-Pack, 3M Cable, 10cm x 28ga (0.36mm)/(TCD-10-3M/TCD-10-3M-P); TCD Electrode, Multi-Pack, 10cm x 28ga (0.36mm)/(TCD-10/TCD-10-P); TCD Electrode, Multi-Pack, 3M Cable, 15cm x 28ga (0.36mm)/(TCD-15-3M/TCD-15-3M-P); TCD Electrode, Multi-Pack, 15cm x 28ga (0.36mm)/(TCD-15/TCD-15-P); TCD Electrode, Multi-Pack, 5cm x 28ga (0.36mm)/(TCD-5/TCD-5-P);
Sold in
Nationwide
Made for
All ages (under 100 years)

Details

Units affected
13320
Illnesses reported
None reported
Manufactured in
25155 Rye Canyon Loop, Valencia, California, United States
Classification
Class II
Recall number
Z-0368-2027

In the FDA's words

Description
TCD Electrodes (Description/REF(Inner/Outer)): TCD Electrode, Multi-Pack, 3M Cable, 10cm x 28ga (0.36mm)/(TCD-10-3M/TCD-10-3M-P); TCD Electrode, Multi-Pack, 10cm x 28ga (0.36mm)/(TCD-10/TCD-10-P); TCD Electrode, Multi-Pack, 3M Cable, 15cm x 28ga (0.36mm)/(TCD-15-3M/TCD-15-3M-P); TCD Electrode, Multi-Pack, 15cm x 28ga (0.36mm)/(TCD-15/TCD-15-P); TCD Electrode, Multi-Pack, 5cm x 28ga (0.36mm)/(TCD-5/TCD-5-P); Radiofrequency probes may have small cut marks on the Tyvek side of the sterile pouch, and if the sterile barrier is compromised and devices are used, this could cause microbial or other foreign material contamination to be introduced into patient tissue, which may lead to infection, pain, inflammation, allergic reaction, toxicity, the need for additional medical and/or surgical intervention. Inner REF/UDI-DI/Lot(Expiration): TCD-10-3M/00813250014396/39749333(7/6/2030), 85009822(7/12/2030); TCD-10/00813250010978/39741131(7/5/2030), 39750861(7/6/2030), 39757187(7/7/2030), 39766608(7/8/2030), 39768774(7/8/2030), 39772208(7/9/2030), 39778427(7/9/2030), 39780344(7/9/2030), 39781367(7/10/2030), 85006486(7/12/2030), 85011925(7/13/2030); TCD-15-3M/00813250014402/39770714(7/8/2030); TCD-15/00813250010985/39741129(7/5/2030), 39746187(7/6/2030), 39780349(7/10/2030), 39783782(7/10/2030); TCD-5/00813250010961/39751579(7/7/2030), 39783599(7/10/2030) Distribution: US Nationwide distribution including in the states of OH, ID, KY, NJ, GA, NY, MO, SC, MN, IA, MI, MA, WI, TX, ME, IN, AR, CO, IL, VT, VA, MS, WA, OR, NV, AZ, UT, FL, WY, CA, OK, NC, TN, MD, DE, LA, HI, CT, WV, AL, NH, ND. Affected quantity: 13320
Hazard
Radiofrequency probes may have small cut marks on the Tyvek side of the sterile pouch, and if the sterile barrier is compromised and devices are used, this could cause microbial or other foreign material contamination to be introduced into patient tissue, which may lead to infection, pain, inflammation, allergic reaction, toxicity, the need for additional medical and/or surgical intervention.

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