Boston Scientific/Cameron Health SQ-RX
Medical device recall Z-0965-2013. Published in FDA’s Enforcement Report on Mar 27, 2013.
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 Mar 27, 2013. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Terminated its status, in FDA’s file
- 17 states named in where it went
- 2090 (570 USA; 1520 OUS) 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 II, the middle of FDA’s three classes.
“Products that might cause a temporary health problem, or pose only a slight threat of a serious nature. Example: a drug that is under-strength but that is not used to treat life-threatening situations.”
openFDA, in plain words, its enforcement report fields.
“Class II is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.”
FDA’s rule, 21 CFR 7.3(m)(2), eCFR.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
What’s wrong with it?
An internal protective fuse can be unintentionally activated while the device is charging its capacitors for shock delivery or induction. Should this occur, the defibrillator would not be able to deliver therapy or communicate with the Q-TECH Model 2020 programmer, and would be unable to emit tones or otherwise respond to magnet application.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
Boston Scientific/Cameron Health SQ-RX Model 1010 subcutaneous pulse generators. The S-ICD System is intended to provide therapy for the treatment of life-threatening ventricular tachyarrhythmias.
2090 (570 USA; 1520 OUS), in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
SERIAL NUMBERS A002804 A003105 A001493 A001784 A001981 A003024 A003197 A001609 A001594 A001733 A002291 A002348 A002373 A002195 A002710 A004131 A001942 A002278 A002399 A002402 A001021 A001136 A001104 A001193 A001392 A002093 A002147 A001134…
Every code shown here, 1,999 characters
SERIAL NUMBERS A002804 A003105 A001493 A001784 A001981 A003024 A003197 A001609 A001594 A001733 A002291 A002348 A002373 A002195 A002710 A004131 A001942 A002278 A002399 A002402 A001021 A001136 A001104 A001193 A001392 A002093 A002147 A001134 A001155 A001063 A001011 A001102 A001012 A001004 A001058 A001010 A001140 A001093 A001170 A001055 A001185 A001144 A001217 A001215 A001241 A001367 A001377 A001405 A001431 A001380 A001468 A001411 A001639 A001688 A001734 A001578 A001654 A001799 A001916 A001903 A002127 A002076 A002425 A002686 297-899 300-895 292-887 A001120 A001085 A001109 A001089 A001122 A001110 A001020 A001052 A001023 A001051 A001062 A001148 A001042 A001106 A001091 A001096 A001126 A001237 A001341 A001354 A001447 A001429 A001533 A001481 A001236 A001119 A001246 A001384 A001267 A001731 A001650 A001774 A001856 A001980 A001752 A002364 A002823 A002826 A002833 A002858 A002889 A002892 A002946 A002997 A002996 A002953 A003386 A003465 A003066 A003382 A003426 A003540 A003563 A001291 A001463 A002985 A001146 A001174 A001040 A001005 A001053 A001180 A001195 A001194 A001188 A001233 A001270 A001273 A001197 A001294 A001368 A001338 A001332 A001152 A001423 A001344 A001443 A001235 A001317 A001363 A001512 A001513 A001538 A001489 A001480 A001334 A001500 A001820 A001680 A001647 A001652 A001630 A001696 A001789 A001740 A001781 A001271 A001711 A001661 A001573 A001772 A001636 A001682 A001750 A001437 A001882 A002050 A002036 A002045 A001910 A002015 A001888 A002068 A001605 A002005 A001860 A002234 A002300 A002337 A002087 A002295 A002272 A002141 A002261 A002243 A001958 A002266 A002014 A002071 A001768 A002158 A002286 A002403 A002194 A002228 A002292 A002418 A002252 A002342 A002459 A002374 A002424 A002485 A002276 A002523 A002027 A002376 A002672 A002645 A002267 A002553 A002608 A002737 A002999 A003124 A003138 A003285 A003449 A004002 A003886 A003694 A003842 A001732 A001660 A001800 A001427 A001418 A001428 A001441 A001454 A001635 A001566 A001697 A001653 A001634 A001811 A001623 A001837 A001793 A001745 A001905…
FDA’s list runs to 16,766 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, USA including the states of AZ, CA, CO, DC, GA, IL, MD, MA, MN, NJ, NY, NC, OH, PA, SC, VA, WA and the countries of AUSTRIA, BELGIUM, CANADA, CZECH REPUBLIC, DENMARK, FRANCE, GERMANY, IRELAND, ITALY, NETHERLANDS, NEW ZEALAND, PORTUGAL, SLOVAKIA, SPAIN, SWEDEN, SWITZERLAND, and the UNITED KINGDOM.
The states and territories these words name
17 states and territories.
Every one of them
- Arizona
- California
- Colorado
- District of Columbia
- Georgia
- Illinois
- Massachusetts
- Maryland
- Minnesota
- North Carolina
- New Jersey
- New York
- Ohio
- Pennsylvania
- South Carolina
- Virginia
- Washington
The words say it went outside the United States too.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
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 Mar 1, 2013.
- FDA classified it on Mar 18, 2013.
- FDA’s Enforcement Report published it on Mar 27, 2013.
- FDA terminated it on May 23, 2013.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- Boston Scientific CRM Corp, of Saint Paul, MN.
- 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 16,766 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.