Enhanced Verify Evaluation Handset (CFN HH90130FA)
Medical device recall Z-1704-2025. Published in FDA’s Enforcement Report on May 7, 2025.
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 7, 2025. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Ongoing its status, in FDA’s file
- Nationwide FDA’s word, and 27 states named
- 534 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?
Evaluation handsets may not be able to communicate with the neurostimulator due to handsets having a faster processing speed than prior handsets. An inability to connect may cause the therapy to stop being delivered and a system error will be displayed. Patient may experience return of underlying disease symptoms (e.g. overactive bladder, urinary retention, or fecal incontinence) based on their response to stimulation during the evaluation period.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
Enhanced Verify Evaluation Handset (CFN HH90130FA)
534, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
UDI-DI 00763000930042 Serial Nos/Lots: NPN0076461 NPN0076462 NPN0076465 NPN0076466 NPN0076467 NPN0076468 NPN0076469 NPN0076470 NPN0076471 NPN0076472 NPN0076473 NPN0076474 NPN0076475 NPN0076476 NPN0076477 NPN0076479 NPN0076480 NPN0076482…
Every code shown here, 1,997 characters
UDI-DI 00763000930042 Serial Nos/Lots: NPN0076461 NPN0076462 NPN0076465 NPN0076466 NPN0076467 NPN0076468 NPN0076469 NPN0076470 NPN0076471 NPN0076472 NPN0076473 NPN0076474 NPN0076475 NPN0076476 NPN0076477 NPN0076479 NPN0076480 NPN0076482 NPN0076483 NPN0076485 NPN0076486 NPN0076487 NPN0076488 NPN0076489 NPN0076490 NPN0076491 NPN0076492 NPN0076493 NPN0076494 NPN0076495 NPN0076496 NPN0076497 NPN0076498 NPN0076499 NPN0076500 NPN0076501 NPN0076502 NPN0076504 NPN0076505 NPN0076506 NPN0076507 NPN0076508 NPN0076509 NPN0076510 NPN0076511 NPN0076512 NPN0076513 NPN0076514 NPN0076515 NPN0076516 NPN0076517 NPN0076518 NPN0076520 NPN0076522 NPN0076523 NPN0076524 NPN0076525 NPN0076526 NPN0076527 NPN0076528 NPN0076529 NPN0076530 NPN0076531 NPN0076532 NPN0076533 NPN0076534 NPN0076535 NPN0076536 NPN0076537 NPN0076538 NPN0076539 NPN0076540 NPN0076541 NPN0076542 NPN0076543 NPN0076545 NPN0076546 NPN0076548 NPN0076550 NPN0076551 NPN0076552 NPN0076553 NPN0076554 NPN0076555 NPN0076556 NPN0076557 NPN0076558 NPN0076559 NPN0076560 NPN0076561 NPN0076562 NPN0076563 NPN0076564 NPN0076565 NPN0076566 NPN0076567 NPN0076568 NPN0076569 NPN0076570 NPN0076571 NPN0076572 NPN0076573 NPN0076575 NPN0076577 NPN0076578 NPN0076579 NPN0076580 NPN0076581 NPN0076582 NPN0076583 NPN0076584 NPN0076585 NPN0076586 NPN0076587 NPN0076588 NPN0076589 NPN0076590 NPN0076591 NPN0076593 NPN0076594 NPN0076596 NPN0076598 NPN0076599 NPN0076602 NPN0076603 NPN0076605 NPN0076607 NPN0076608 NPN0076609 NPN0076610 NPN0076611 NPN0076612 NPN0076613 NPN0076614 NPN0076616 NPN0076617 NPN0076618 NPN0076619 NPN0076620 NPN0076621 NPN0076622 NPN0076623 NPN0076624 NPN0076625 NPN0076626 NPN0076627 NPN0076628 NPN0076629 NPN0076630 NPN0076631 NPN0076632 NPN0076633 NPN0076634 NPN0076635 NPN0076636 NPN0076637 NPN0076638 NPN0076639 NPN0076640 NPN0076641 NPN0076642 NPN0076643 NPN0076644 NPN0076645 NPN0076646 NPN0076647 NPN0076649 NPN0076650 NPN0076651 NPN0076655 NPN0076656 NPN0076657 NPN0076658 NPN0076659 NPN0076661 NPN0076662 NPN0076663 NPN0076664…
FDA’s list runs to 5,912 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 including in the states of AR, AZ, CA, CO, CT, FL, GA, IA, IL, IN, LA, MA, MD, MI, MN, MS, NC, NE, NJ, NM, NY, OH, OR, PA, TX, WA, WI.
The states and territories these words name
27 states and territories.
Every one of them
- Arkansas
- Arizona
- California
- Colorado
- Connecticut
- Florida
- Georgia
- Iowa
- Illinois
- Indiana
- Louisiana
- Massachusetts
- Maryland
- Michigan
- Minnesota
- Mississippi
- North Carolina
- Nebraska
- New Jersey
- New Mexico
- New York
- Ohio
- Oregon
- Pennsylvania
- Texas
- Washington
- Wisconsin
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?
Ongoing, in FDA’s file.
“A recall which is currently in progress.”
openFDA, on “On-Going”, 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 Apr 3, 2025.
- FDA classified it on Apr 30, 2025.
- FDA’s Enforcement Report published it on May 7, 2025.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- Medtronic Neuromodulation, of Minneapolis, MN.
- Who began it, in FDA’s words: Voluntary: Firm initiated.
- How the firm first told its customers: Visit.
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 5,912 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
-
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.