Fortify VR
Medical device recall Z-0003-2018. Published in FDA’s Enforcement Report on Oct 18, 2017.
- 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 Oct 18, 2017. 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
- 90,563 units 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?
The device may exhibit premature battery depletion.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
Fortify VR - Model Numbers: CD1231-40 and CD1231-40Q; Fortify ST VR, Model Numbers: CD1241-40 and CD1241-40Q; Fortify Assura VR, Model Numbers: CD1257-40, CD1257-40Q, CD1357-40C, CD1357-40Q; Fortify Assura ST VR, Model Numbers: CD1263-40, CD1263-40Q, CD1363-40C, CD1363-40Q; Fortify DR, Model Numbers: CD2231-40 and CD2231-40Q; Fortify ST DR, Model Numbers: CD2241-40 and CD2241-40Q; Fortify Assura DR, Model Numbers: CD2257-40, CD2257-40Q, CD2357-40C, CD2357-40Q; Fortify Assura ST DR, Model Numbers: CD2263-40, CD2263-40Q, CD2363-40C, CD2363-40Q Product Usage Fortify and Fortify Assura implantable cardioverter defibrillators (ICDS) are intended to provided ventricular anti-tachycardia pacing and ventricular defibrillation for automated treatment of life threatening ventricular arrhythmias. The devices may also be programmed to provide single or dual chamber bradycardia pacing
90,563 units, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Serial Numbers: 1072092 1072099 1072095 610414 645754 645136 643980 719546 1176494 1176492 741560 810336 630647 643609 1161698 756189 736390 1161694 610846 733015 717362 788849 760066 7003656 622669 627017 627314 627696 610840 612400…
Every code shown here, 1,999 characters
Serial Numbers: 1072092 1072099 1072095 610414 645754 645136 643980 719546 1176494 1176492 741560 810336 630647 643609 1161698 756189 736390 1161694 610846 733015 717362 788849 760066 7003656 622669 627017 627314 627696 610840 612400 741610 737607 705649 733310 738921 745376 754552 727079 725262 795252 789466 644370 607810 616517 625042 633253 625041 632204 642059 645143 629082 737580 789446 757787 709960 729842 755858 789525 625869 619824 619847 609493 646400 1065602 726655 739242 628904 741306 783806 717461 641150 648989 648991 643047 789524 617510 617804 1055329 630653 783829 1135487 7003653 608931 732969 643253 645123 608547 635511 635378 635896 727026 1135486 1072091 1072100 634489 635223 641344 645740 630638 611708 631908 631760 634635 640772 1022741 768797 1055327 749407 749320 1059014 748448 608532 633126 789450 1062336 733013 629481 1011653 645749 810063 782410 629631 626450 1048341 1048340 806500 755820 640966 611254 635709 613522 739784 1022723 727083 644846 645141 635382 615968 806544 1065599 726619 1142330 610417 615451 806554 633128 747894 1142331 630662 612822 634031 633843 810128 1062342 614224 615974 1022737 626452 810288 727058 1160843 1160844 1160847 748443 1059015 810316 1160848 1160838 637429 731994 741556 1000243 1087441 1053725 1074323 810344 810325 1053723 1022743 810326 748399 1011661 810355 633099 608810 810109 647274 641681 1130635 1000237 619830 806560 636245 738940 633107 633431 643038 635227 648985 642258 632198 739303 632203 739790 810115 642440 1053722 732978 747950 1138900 1048342 636397 640578 640774 789527 1062343 1062338 635705 1087444 1087442 1022733 788846 640777 1065603 1065609 641532 756172 1056289 1065600 1078433 1055332 1138899 728667 643247 629485 810108 643992 644386 641682 7005025 7005037 1022724 795292 751418 1138908 628785 616518 624483 620628 1062339 806486 806487 629334 1087443 1055334 806559 753252 806562 612963 629630 806578 755850 1062344 1055325 788905 1048343 643793 1055322 742890 1146881 644853 1096895 1022744…
FDA’s list runs to 770,035 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.
US Nationwide Distribution
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.
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 Aug 28, 2017.
- FDA classified it on Oct 10, 2017.
- FDA’s Enforcement Report published it on Oct 18, 2017.
- FDA terminated it on Jan 20, 2024.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- St Jude Medical Inc., 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 770,035 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
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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.