EXCOR Pediatric Ventricular Assist Device Blood Pumps, Models: P10P-001
Medical device recall Z-1618-2023. Published in FDA’s Enforcement Report on May 31, 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 May 31, 2023. Copied from openFDA on Oct 20, 2026.
- Class I FDA’s most serious class (needs attention)
- Terminated its status, in FDA’s file
- 16 states named in where it went
- 335 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?
There is a potential for a disruption in one or more of the triple layer membranes of the ventricular assist device. Recall occurred in 2018, and was retrospectively reported.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
EXCOR Pediatric Ventricular Assist Device Blood Pumps, Models: P10P-001 (10 ml blood pump); P15P-001 (10 ml blood pump); P25P-001x01 (25 ml blood pump); P30P-001x01 (30 ml blood pump), P50P-001 (50 ml blood pump); P60P-001 (60 ml blood pump). Recall occurred in 2018, and was retrospectively reported.
335 units, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
P10P-001 (UDI-DI: 04260090040102)- Serial Numbers: 1520081 1520100 1520309 1520087 1520345 1720280 1620177 1520367 1520344 1620159 1620696 1620699 1720274 1620693 1620669 1720279 1720276 1720329 1520037 1620161 1620157 1620169 1620620…
Every code shown here, 2,000 characters
P10P-001 (UDI-DI: 04260090040102)- Serial Numbers: 1520081 1520100 1520309 1520087 1520345 1720280 1620177 1520367 1520344 1620159 1620696 1620699 1720274 1620693 1620669 1720279 1720276 1720329 1520037 1620161 1620157 1620169 1620620 1620649 1620662 1620652 1620650 1720298 1620664 1620622 1620663 1720299 1520041 1620666 1620178 1421365 1520011 1520079 1520080 1520098 1520099 1520316 1520317 1620162 1620638 1620654 1620668 1620671 1620698 1620667 1620665 1620670 1520038 1520339 1620697 1520349 1520054 1620691 1720277 1720275 1720341 1520055 1520068 1520302 1520343 1520362 1520301 1520318 1520336 1520337 1520355 1421364 1720330 1720351 1620653 1620655 1520036 1520035 1520016 1520017 1520387 1520334 1520371 1620695 1520031 1520033 1520032 1620694 1520026 1520027 1520352 1520347 1620163 1520018 1520333 1520321 1520348 1620621 1720342 1720343 1520354 1421373 1520042 1520050 1520365 1520350 1720331 1520342 1520366 1520381 1520380; P15P-001 (UDI-DI: 04260090040157) - Serial Numbers: ; 1520267 1520268 1520459 1520278 1520277 1620367 1720423 1720549 1520393 1520253 1620364 1620388 1620396 1620456 1720386 1520469 1520486 1520449 1520458 1520392 1520477 1520481 1620210 1620381 1620387 1620429 1620430 1820095 1520247 1520280 1520476 1620199 1620207 1520274 1421261 1520169 1421234 1820074 1820075 1820098 1720430 1820094 1520213 1520181 1520176 1421277 1520177 1520286 1520279 1421273 1520282 1520255 1520281 1820099 1620219 1520291 1520264 1520262 1520265 1620457 1720361 1620438 1720362 1620458 1720389 1620427 1820093 1520395 1520410 1520397 1720435 1720384 1720387 1720551 1520275 1520292 1520297 1520299 1520390 1520401 1520300 1720365 1720378 1720376 1720379 1620368 1620397 1620418 1720437 1720427 1720554 1520400 1520441 1620206 1620220 1620420 1620423 1820067 1720424 1720558 1421263 1421264 1720552 1720553 1520193 1520485 1620440 1620421 1620422 1620366 1520287 1520480 1620385 1520294 P25P-001x01 (UDI-DI: 04260090040119)- Serial Numbers: 1620559 1620486 1620496 1620546 1620562…
FDA’s list runs to 2,998 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.
Distribution to US states of MA, TX, WI, CA, SC, FL, CO, NY, PA, NC, UT, GA, MN, OH, AZ, AL, and Canada
The states and territories these words name
16 states and territories.
Every one of them
- Alabama
- Arizona
- California
- Colorado
- Florida
- Georgia
- Massachusetts
- Minnesota
- North Carolina
- New York
- Ohio
- Pennsylvania
- South Carolina
- Texas
- Utah
- Wisconsin
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 May 18, 2018.
- FDA classified it on May 24, 2023.
- FDA’s Enforcement Report published it on May 31, 2023.
- FDA terminated it on Jun 6, 2024.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- BERLIN HEART GMBH, of Berlin, Germany.
- Who began it, in FDA’s words: Voluntary: Firm initiated.
- How the firm first told its customers: E-Mail.
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 2,998 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.