Hearth Record

Thumper Cardiopulmonary Resuscitator

Medical device recall Z-1632-2018. Published in FDA’s Enforcement Report on May 16, 2018.

FDA’s own record, on accessdata.fda.gov

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 16, 2018. Copied from openFDA on Oct 20, 2026.

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 III, the least serious of FDA’s three classes.

“Products that are unlikely to cause any adverse health reaction, but that violate FDA labeling or manufacturing laws. Examples include: a minor container defect and lack of English labeling in a retail food.”

openFDA, in plain words, its enforcement report fields.

“Class III is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.”

FDA’s rule, 21 CFR 7.3(m)(3), eCFR.

Source:

What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.

What’s wrong with it?

A performance issue with the chest depth needle valve (CDNV) may arise where turning the knob will not deliver any compression depth to the piston during the first 5 revolutions of the knob.The last ¿ to ¿ revolution of the knob could deliver a full 8cm of compression.

Source:

FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.

Which ones are recalled?

Thumper Cardiopulmonary Resuscitator, Model 1007CCV, Catalog No. 15370 Product Usage: The device is used to perform Cardiopulmonary Resuscitation (CRP) on adult patients and only adult patients in cases of clinical death as defined by a lack of spontaneous breathing and pulse.

38 devices, in FDA’s words.

Source:

FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.

Codes to check against yours

CDNV - SN Installed In - Mfr Date 5519 CCV-2181 09/17 5518 CCV-2182 09/17 5516 CCV-2183 09/17 5517 CCV-2184 09/17 5522 CCV-2196 09/17 5531 CCV-2200 12/17 5533 CCV-2201 12/17 5538 CCV-2202 12/17 5524 CCV-2203 12/17 5523 CCV-2204 12/17 5526…

Every code shown here, 793 characters

CDNV - SN Installed In - Mfr Date 5519 CCV-2181 09/17 5518 CCV-2182 09/17 5516 CCV-2183 09/17 5517 CCV-2184 09/17 5522 CCV-2196 09/17 5531 CCV-2200 12/17 5533 CCV-2201 12/17 5538 CCV-2202 12/17 5524 CCV-2203 12/17 5523 CCV-2204 12/17 5526 CCV-2205 12/17 5528 CCV-2206 12/17 5529 CCV-2208 12/17 5535 CCV-2209 12/17 5530 CCV-2210 12/17 5534 CCV-2211 12/17 5539 CCV-2212 12/17 5520 CCV-2213 12/17 5532 CCV-2214 12/17 5525 CCV-2215 12/17 5536 CCV-2216 12/17 5537 CCV-2217 12/17 5521 CCV-2218 12/17 5527 CCV-2219 12/17 5541 CCV-2220 01/18 5550 CCV-2221 01/18 5546 CCV-2222 01/18 5544 CCV-2223 01/18 5543 CCV-2224 01/18 5542 CCV-2225 01/18 5553 CCV-2226 01/18 5547 CCV-2228 01/18 5549 CCV-2229 01/18 5548 CCV-2230 01/18 5545 CCV-2231 01/18 5540 CCV-2232 01/18 5555 CCV-2233 01/18 5554 CCV-2237 01/18

Source:

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.

Distributed to China.

These words name no state.

Source:

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.

Source:

What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.

  • The firm began the recall on Feb 13, 2018.
  • FDA classified it on May 4, 2018.
  • FDA’s Enforcement Report published it on May 16, 2018.
  • FDA terminated it on Apr 3, 2019.
Source:

FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.

Who is recalling it?

  • Michigan Instruments, Inc., of Grand Rapids, MI.
  • Who began it, in FDA’s words: Voluntary: Firm initiated.
  • How the firm first told its customers: E-Mail.
Source:

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.
Source:

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.

Source:

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.

How to read a record

Four things every record does, shown on an example record made up for this guide.

An example record, made up for this guide

An example nursing home

Made up for this guide: no real place is shown

Not fully inspected in over two years (CMS flag)

11 health citations at the latest inspection cycle

The state average is 14.3.

Source:

CMS, State and US Averages and Health Deficiencies. Released Oct 28, 2026. Updated monthly.

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Who published it, when, and how often it changes sit beside each fact, with a link to the agency’s own file.

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