VenaFlow Elite 30B-B and 30BI-B Product Usage: The VenaFlow Elite System is a compression pump used for the…
Medical device recall Z-1661-2013. Published in FDA’s Enforcement Report on Jul 10, 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 Jul 10, 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
- 2491 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?
DJO, LLC has recently identified a product safety issue with the battery assembly for the VenaFlow 30B-B and 30 BI-B products. There is a potential for battery leakage which could result in thermal meltdown (fire).
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
VenaFlow Elite 30B-B and 30BI-B Product Usage: The VenaFlow Elite System is a compression pump used for the prevention of Deep Vein Thrombosis.
2491, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Model Numbers: 30B-B and 30BI-B. Serial Numbers: E00026 E00029 E00030 E00031 E00036 E00039 E00045 E00050 E00051 E00052 E00053 E00056 E00057 E00058 E00060 E00143 E00147 E00151 E00156 E00163 E00169 E00175 E00178 E00184 E00191 E00200 E00201…
Every code shown here, 1,995 characters
Model Numbers: 30B-B and 30BI-B. Serial Numbers: E00026 E00029 E00030 E00031 E00036 E00039 E00045 E00050 E00051 E00052 E00053 E00056 E00057 E00058 E00060 E00143 E00147 E00151 E00156 E00163 E00169 E00175 E00178 E00184 E00191 E00200 E00201 E00203 E00205 E00206 E00211 E00211 E00222 E00227 E00234 E00236 E00238 E00239 E00240 E00241 E00242 E00243 E00245 E00246 E00247 E00248 E00250 E00252 E00258 E00260 E00261 E00262 E00264 E00267 E00269 E00271 E00272 E00273 E00274 E00276 E00281 E00283 E00289 E00296 E00298 E00301 E00303 E00305 E00306 E00308 E00313 E00314 E00315 E00317 E00321 E00322 E00326 E00329 E00330 E00332 E00335 E00336 E00337 E00339 E00340 E00342 E00344 E00347 E00348 E00351 E00352 E00357 E00358 E00363 E00368 E00370 E00371 E00373 E00375 E00376 E00377 E00379 E00380 E00381 E00384 E00385 E00388 E00390 E00391 E00392 E00393 E00394 E00395 E00396 E00397 E00398 E00399 E00400 E00401 E00402 E00403 E00404 E00406 E00407 E00408 E00409 E00410 E00411 E00412 E00413 E00414 E00415 E00416 E00417 E00418 E00419 E00420 E00422 E00426 E00429 E00430 E00432 E00433 E00434 E00436 E00437 E00439 E00492 E00503 E00516 E00529 E00533 E00540 E00541 E00543 E00546 E00548 E00559 E00563 E00570 E00576 E00577 E00580 E00582 E00583 E00584 E00585 E00589 E00590 E00591 E00594 E00595 E00596 E00598 E00599 E00600 E00602 E00604 E00605 E00606 E00607 E00608 E00609 E00610 E00611 E00612 E00613 E00614 E00615 E00616 E00617 E00618 E00619 E00620 E00621 E00622 E00623 E00628 E00629 E00630 E00631 E00632 E00634 E00635 E00636 E00637 E00638 E00639 E00642 E00643 E00644 E00645 E00646 E00647 E00649 E00651 E00652 E00656 E00657 E00658 E00659 E00660 E00661 E00662 E00663 E00664 E00665 E00666 E00669 E00670 E00672 E00673 E00675 E00676 E00677 E00679 E00680 E00682 E00683 E00686 E00687 E00688 E00689 E00692 E00693 E00696 E00698 E00699 E00700 E00701 E00703 E00704 E00705 E00706 E00707 E00708 E00710 E00712 E00714 E00715 E00716 E00718 E00719 E00720 E00723 E00724 E00725 E00727 E00728 E00730 E00733 E00734 E00735 E00736 E00737 E00739 E00740 E00741…
FDA’s list runs to 17,601 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 Nationwide and countries of: Australia, Belgium, China, Guatemala CentroAmeria, France, Hong Kong, India,Italy, Korea, Lebanon, Malaysia, Morocco, Pakistan, Paraguay, The Netherlands, Romania, Singapore, Spain, Sweden, Thailand, Turkey, United Arab Emirates, United Kingdom and Venezula.
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 May 28, 2013.
- FDA classified it on Jul 3, 2013.
- FDA’s Enforcement Report published it on Jul 10, 2013.
- FDA terminated it on Feb 13, 2014.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- DJO, LLC, of Vista, CA.
- 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 17,601 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.