Optisure Dual Coil Defibrillation Leads
Medical device recall Z-0660-2016. Published in FDA’s Enforcement Report on Jan 27, 2016.
- FDA Class I
No Watch here, and no alerts: openFDA asks that its enforcement data “should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall” (openFDA). For FDA’s own recall emails, subscribe at FDA. FDA’s own record is on accessdata.fda.gov.
The short answer
Published in FDA’s Enforcement Report on Jan 27, 2016. Copied from openFDA on Oct 20, 2026.
- Class I FDA’s most serious class (needs attention)
- Terminated its status, in FDA’s file
- Nationwide FDA’s word for where it went
- 447 units total (281 units in US) how much, in FDA’s words
Every line below is in FDA’s own words, with its source beside it. FDA’s terms are explained in FDA’s own words.
How serious is it, by FDA’s class?
Class I, the most serious of FDA’s three classes.
“Dangerous or defective products that predictably could cause serious health problems or death. Examples include: food found to contain botulinum toxin, food with undeclared allergens, a label mix-up on a lifesaving drug, or a defective artificial heart valve.”
openFDA, in plain words, its enforcement report fields.
“Class I is a situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death.”
FDA’s rule, 21 CFR 7.3(m)(1), eCFR.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
What’s wrong with it?
Leads may have been compromised during the manufacturing process, with cuts in the insulation layer of the SVC shock coil.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
Optisure Dual Coil Defibrillation Leads, Model No. LDA220, LDA220Q, LDA230Q, LDP220Q. St. Jude Medical. Designed for long term attachment to an Implantable Cardioverter Defibrillator (ICD).
447 units total (281 units in US), in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
BRE010002 BRE010016 BRE010032 BRE010033 BRE010034 BRE010035 BRE010037 BRE010039 BRE010040 BRE010042 BRE010044 BRE010046 BRE010062 BRE010066 BRE010075 BRE010077 BRE010082 BRE010096 BRE010097 BRE010098 BRE010099 BRE010165 BRE010166 BRE010173…
Every code shown here, 2,000 characters
BRE010002 BRE010016 BRE010032 BRE010033 BRE010034 BRE010035 BRE010037 BRE010039 BRE010040 BRE010042 BRE010044 BRE010046 BRE010062 BRE010066 BRE010075 BRE010077 BRE010082 BRE010096 BRE010097 BRE010098 BRE010099 BRE010165 BRE010166 BRE010173 BRE010183 BRE010185 BRE010191 BRE010194 BRE010195 BRE010205 BRE010208 BRE010215 BRE010220 BRE010226 BRE010232 BRE010235 BRE010240 BRE010241 BRE010258 BRE010299 BRE013300 BRE013302 BRG010102 BRG010103 BRG010116 BRG010174 BRG010178 BRG010179 BRG010188 BRG010205 BRG010206 BRG010207 BRG010213 BRG010232 BRG010233 BRG010237 BRG010238 BRG010246 BRG010247 BRG010248 BRG010249 BRG010250 BRG010264 BRG010285 BRG010298 BRG010350 BRG010383 BRG010396 BRG010404 BRG010405 BRG010411 BRG010415 BRG010574 BRG010619 BRG010625 BRG010658 BRG010664 BRG010684 BRG010721 BRG010722 BRG010723 BRG010770 BRG010812 BRG010814 BRG010818 BRG010820 BRG010821 BRG010822 BRG010937 BRG010938 BRG010939 BRG010946 BRG010947 BRG010967 BRG010978 BRG010979 BRG010982 BRG010983 BRG010992 BRG010993 BRG010998 BRG010999 BRG011013 BRG011016 BRG011057 BRG011085 BRG011300 BRG011301 BRG011302 BRG011306 BRG011307 BRG011318 BRG011326 BRG011512 BRH010166 BRH010167 BRH010168 BRH010174 BRH010175 BRH010187 BRH010190 BRH010197 BRH010198 BRH010307 BRH010310 BRH010348 BRH010352 BRH010361 BRH010373 BRH010387 BRH010391 BRH010401 BRH010402 BRH010421 BRH010428 BRH010439 BRH010442 BRH010445 BRH010454 BRH010455 BRH010497 BRH010518 BRH010519 BRH010522 BRH010523 BRH010538 BRH010549 BRH010550 BRH010574 BRH010603 BRH010607 BRH010644 BRH010645 BRH010658 BRH010711 BRH010794 BRH010801 BRH010802 BRH010823 BRH010834 BRH010849 BRH010863 BRH010866 BRH010871 BRH010872 BRH010873 BRH010881 BRH010886 BRH010887 BRH010893 BRH010905 BRH010906 BRH010916 BRH010917 BRH010927 BRH010931 BRH010963 BRH010964 BRH010970 BRH010972 BRH010980 BRH010982 BRH011002 BRH011003 BRH011004 BRH011005 BRH011015 BRH011016 BRH011018 BRH011019 BRH011021 BRH011023 BRH011024 BRH011025 BRH011058 BRH011059 BRH011060 BRH011061 BRH011067 BRH011069…
FDA’s list runs to 4,469 characters. The first part is shown; the rest is on FDA’s record.
Copied exactly as FDA lists them: lot and serial numbers, dates and other codes on the product or its label.
Where did it go?
FDA’s words for the “general area of initial distribution”: where the firm first shipped it.
Worldwide Distribution US (nationwide), Belgium, Switzerland, Germany, France, United Kingdom, India, Italy, Japan, Luxembourg, The Netherlands, Saudi Arabia, and Sweden.
These words name no state.
What FDA means by nationwide
“The term “nationwide” is defined to mean the fifty states or a significant portion. Note that subsequent distribution by the consignees to other parties may not be included.”
openFDA, its enforcement report fields.
The words say it went outside the United States too.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
Is it still going on?
Terminated, in FDA’s file.
“FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.”
openFDA, on “Terminated”, its enforcement report fields.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
- The firm began the recall on Nov 3, 2015.
- FDA classified it on Jan 20, 2016.
- FDA’s Enforcement Report published it on Jan 27, 2016.
- FDA terminated it on May 10, 2019.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- St Jude Medical Cardiac Rhythm Management Division, of Sylmar, CA.
- Who began it, in FDA’s words: Voluntary: Firm initiated.
- How the firm first told its customers: Letter.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
What this record can’t tell you
- Whether your own one is affected: compare the codes, dates and numbers above with yours. When unsure, ask the firm or the store.
- Where it went after the firm’s first shipments. FDA’s words cover the firm’s initial distribution, and, in FDA’s words, “subsequent distribution by the consignees to other parties may not be included.”
- How many have been returned, corrected or destroyed: FDA’s report doesn’t say.
- Whether anyone was hurt or fell ill: the report doesn’t say.
- How current it is: openFDA publishes FDA’s Enforcement Report weekly, after FDA does, and a firm can announce a recall weeks before it appears there. openFDA’s own caution: “This data should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall.”
- FDA’s list of codes runs to 4,469 characters; the first part is shown here, and the rest is on FDA’s record.
- A product with no recall here isn’t safe by that: FDA’s report lists the recalls FDA classified, and when.
Hearth Record wrote these lines; the quotations are FDA’s.
Sources
-
U.S. Food and Drug Administration, Device recall enforcement reports.
Released Oct 14, 2026 and checked Oct 20, 2026. Updated weekly. Public domain (CC0 1.0, openFDA). FDA asks that nothing suggest it endorses this site.
Recalls of food, medicines, medical devices, pet food and animal drugs are from the U.S. Food and Drug Administration (FDA). FDA does not endorse Hearth Record. openFDA: “Do not rely on openFDA to make decisions regarding medical care.” Copied on Oct 20, 2026.