SHIP KIT, LIFESPARC, CONTROLLER AND ACCESSORIES - 5900-0000
Medical device recall Z-0926-2023. Published in FDA’s Enforcement Report on Jan 25, 2023.
- 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 25, 2023. 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
- 763 (US only) 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?
A software update (v1.1.5) has been developed to address the issue of Critical Failure which can occur on the LifeSPARC Controller. The Critical Failure was first addressed in the firm’s recall initiated July 21, 2022. During the Critical Failure, the software freezes or crashes and the screen does not display data.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
SHIP KIT, LIFESPARC, CONTROLLER AND ACCESSORIES - 5900-0000; SHIP KIT, LIFESPARC, CONTROLLER ONLY - 5900-0001. Component of LifeSPARC System, used to pump the blood through an extracorporeal circuit.
763 (US only), in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Model No. 5900-0000 - UDI/DI 00814112020562 Model No. 5900-0001 - UDI/DI 00814112020623 Serial Numbers C00115 C50232 C50253 C50403 C00195 C50619 C50623 C50161 C50167 C50362 C50388 C50432 C50505 C00189 C50648 C50437 C50671 C50690 C00048…
Every code shown here, 2,000 characters
Model No. 5900-0000 - UDI/DI 00814112020562 Model No. 5900-0001 - UDI/DI 00814112020623 Serial Numbers C00115 C50232 C50253 C50403 C00195 C50619 C50623 C50161 C50167 C50362 C50388 C50432 C50505 C00189 C50648 C50437 C50671 C50690 C00048 C00087 C50114 C50135 C00149 C50274 C50506 C50308 C50319 C00040 C00107 C50207 C50160 C50016 C50604 C50493 C50355 C50633 C00126 C00155 C50113 C00041 C00135 C00042 C00035 C50012 C50019 C50073 C00176 C50386 C50677 C00052 C00076 C00092 C50384 C50490 C50679 C00095 C50149 C00182 C50392 C50337 C50451 C50708 C50306 C50460 C50512 C50082 C50174 C00151 C50328 C50111 C50501 C00157 C50363 C50476 C50701 C50212 C50219 C50350 C00174 C00006 C50076 C50105 C50235 C50613 C50197 C50375 C50463 C50517 C50632 C50653 C50662 C00199 C00205 C50699 C50269 C50398 C50618 C50606 C50645 C50100 C50101 C50626 C50204 C50266 C50330 C50031 C50050 C50241 C50524 C00188 C00197 C50131 C50181 C50365 C00038 C50237 C00190 C50598 C50283 C00143 C50287 C50288 C50259 C50270 C00185 C50202 C00209 C50639 C00158 C50357 C50601 C50289 C50592 C50640 C50059 C50065 C50097 C50043 C50037 C50072 C50096 C50153 C50140 C50703 C50391 C50642 C50536 C50682 C50314 C50354 C50470 C50409 C50526 C50146 C50225 C50226 C50001 C50090 C00169 C00023 C00161 C50224 C50458 C50525 C50581 C50591 C50428 C50466 C00202 C00196 C50593 C50539 C50303 C00127 C00063 C50211 C50229 C50280 C00167 C50374 C50387 C00141 C00136 C00145 C50312 C00073 C50243 C00150 C50222 C50343 C50425 C00053 C00057 C50652 C00113 C00114 C50038 C50247 C50651 C50654 C00203 C50521 C50689 C00072 C50208 C50485 C50492 C50057 C50126 C00152 C00094 C50389 C50399 C50453 C50148 C50168 C00148 C50456 C50015 C00098 C50465 C50448 C50406 C50026 C50044 C50162 C00016 C50056 C50170 C00031 C50042 C50058 C50469 C00039 C00078 C00093 C00089 C50157 C50234 C50236 C50426 C50318 C50395 C00166 C50327 C50356 C50410 C50471 C50262 C50385 C50195 C50196 C00132 C00130 C50381 C50436 C50435 C50047 C50055 C50064 C50429 C50688 C50370 C50377 C00198 C50486 C50627 C50664 C50066 C50078 C50468…
FDA’s list runs to 4,225 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 Dec 5, 2022.
- FDA classified it on Jan 19, 2023.
- FDA’s Enforcement Report published it on Jan 25, 2023.
- FDA terminated it on Aug 8, 2023.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- Cardiac Assist, Inc, of Pittsburgh, PA.
- 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 4,225 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.