Companion External Battery
Medical device recall Z-0620-2013. Published in FDA’s Enforcement Report on Jan 9, 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 Jan 9, 2013. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Terminated its status, in FDA’s file
- Nationwide FDA’s word for where it went
- 81 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 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?
Syncardia Systems is recalling the Companion External Batteries used with the Companion 2 Driver System because they may potentially be at risk of thermal events and/or other physical damage such as melting, charring and/or burning.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
Companion External Battery, Part Number: 293001-001 The Companion External Battery is a component of the Companion 2 Driver System and the Companion Driver System. Both Driver Systems, with the temporary Total Artificial Heart (TAH-t) are indicated for use as a bridge to transplantation in cardiac transplant-eligible candidates at risk of imminent death from biventricular failure.
81 units, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Serial # Lot# 00067 11/12 00071 11/12 00073 11/12 00076 11/12 00079 11/12 00085 11/12 00086 11/12 00087 11/12 00089 28/12 00091 28/12 00092 28/12 00093 28/12 00094 28/12 00095 28/12 00098 28/12 00099 28/12 00101 28/12 00102 28/12 00103…
Every code shown here, 985 characters
Serial # Lot# 00067 11/12 00071 11/12 00073 11/12 00076 11/12 00079 11/12 00085 11/12 00086 11/12 00087 11/12 00089 28/12 00091 28/12 00092 28/12 00093 28/12 00094 28/12 00095 28/12 00098 28/12 00099 28/12 00101 28/12 00102 28/12 00103 28/12 00104 28/12 00105 28/12 00106 28/12 00107 28/12 00108 28/12 00109 28/12 00110 28/12 00111 28/12 00112 28/12 00113 28/12 00114 28/12 00115 28/12 00116 28/12 00117 28/12 00118 28/12 00119 28/12 00120 28/12 00121 28/12 00122 28/12 00123 28/12 00124 28/12 00125 28/12 00126 28/12 00127 28/12 00128 28/12 00129 28/12 00130 28/12 00131 28/12 00132 28/12 00133 28/12 00134 28/12 00135 28/12 00136 28/12 00137 28/12 00138 28/12 00139 28/12 00140 28/12 00141 28/12 00142 28/12 00143 28/12 00144 28/12 00145 28/12 00146 28/12 00147 28/12 00148 28/12 00068 11/12 00069 11/12 00070 11/12 00072 11/12 00075 11/12 00077 11/12 00078 11/12 00080 11/12 00081 11/12 00082 11/12 00083 11/12 00084 11/12 00088 11/12 00090 28/12 00096 28/12 00097 28/12 00100 28/12
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)
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 Dec 5, 2012.
- FDA classified it on Dec 28, 2012.
- FDA’s Enforcement Report published it on Jan 9, 2013.
- FDA terminated it on Jun 7, 2013.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- SynCardia Systems Inc., of Tucson, AZ.
- 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.”
- 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.