ZvuRecalls & reported problems across all models
Diversatek Healthcare, Inc. · 3 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
2 open recalls name at least one Zvu model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls
- 2
We found 3 models of Zvu by Diversatek Healthcare, Inc. in the FDA's device registry (GUDID). Together they are named in 1 adverse event report in the FDA's MAUDE database, received between Jan 6, 2025 and Jan 6, 2025 — classified as 1 malfunction.
The most frequently reported specific device problem is “Material Split, Cut or Torn” (1 report).
2 FDA recall records name at least one of these models by its device identifier, 2 still open.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Zvu recalls
FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.
- Jun 4, 2025Open, Classified
Anorectal manometry procedure kit outer kit label is mislabeled with an incorrect expiration date; the manufacturing date was used in place of the expiration date. All inner labels on kit components display the correct expiration date.
Z-2324-2025 · Root cause: Error in labeling · Recall details · FDA record ↗
- Jul 25, 2023Open, Classified
GI Software labelled as revision 3.3.0 is incorrectly labeled and is in fact revision 3.2.0.
Z-2521-2023 · Root cause: Labeling Change Control · Recall details · FDA record ↗
Most reported Zvu problems
Device problems
- Material Split, Cut or Torn1
- No Apparent Adverse Event1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Zvu models
3 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Zvu® ZVU-3System, Gastrointestinal Motility (Electrical)1 recall0 reports
- Zvu® HRAM-PROC-10System, Gastrointestinal Motility (Electrical)1 recall0 reports
- Zvu® HRIM-201System, Gastrointestinal Motility (Electrical)1 report
Recent Zvu adverse event reports
The 1 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionJan 6, 2025No Apparent Adverse Event; Material Split, Cut or Torn; No Apparent Adverse Event; Material Split, Cut or Torn
DESCRIPTION FROM MW5162137 VOLUNTARY USER REPORT: PRIOR TO PATIENT: PROBE WAS TESTED UNDER THE CALIBRATION PROCESS AND APPEARED TO BE IN WORKING ORDER. ALL SENSORS WERE GREEN WHICH INDICATED ALL SENSORS WERE WORKING PROPERLY. PROBE INSERTED INTO NARE WITHOUT DIFFICULTY. DATA REFLECTED ON SCREEN SHOWED THAT PROBE NEEDED INSERTED MORE AND THAT THERE WAS POSSIBLE COILING. PULLED PROBE OUT APPROXIMATELY 6 CM (IN ORDER TO FIX POSSIBLE COILING) AND THEN ADVANCED PROBE. PATIENT TOLERATED WELL. STILL DID NOT SEE ACCURATE DATA ON THE MONITOR (NEEDED ADVANCED MORE TO SEE THE OUTFLOW PORTION OF THE SWALLOW). SAT PATIENT UP TO ATTEMPT BETTER PLACEMENT AGAIN. PULLED PROBE OUT APPROXIMATELY HALFWAY AND PATIENT POINTED TO MOUTH (PROBE WAS NOW COILED IN HER MOUTH AFTER SOME MILD COUGHING/GAGGING). IT WAS DECIDED TO COMPLETELY REMOVE THE PROBE IN ORDER TO TRY A SECOND ATTEMPT. ONCE PROBE WAS REMOVED IT WAS IMMEDIATELY NOTICED THAT IT WAS BROKEN. PATIENT TOLERATED WELL. NO VISIBLE BLEEDING FROM MOUTH/NARES. SMALL AMOUNT OF BLOOD WAS NOTED ON PROBE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21084847 ↗
Other Diversatek Healthcare, Inc. products
All Diversatek Healthcare, Inc. devices →Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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