basixCOMPAKRecalls & reported problems across all models
Merit Medical Systems, Inc. · 34 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
2 open recalls name at least one basixCOMPAK model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 34
- Deaths reported
- 1
- Injuries reported
- 2
- Recalls
- 2
We found 34 models of basixCOMPAK by Merit Medical Systems, Inc. in the FDA's device registry (GUDID). Together they are named in 34 adverse event reports in the FDA's MAUDE database, received between Feb 6, 2020 and Sep 17, 2026 — classified as 1 death, 2 injuries, 31 malfunctions.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (23 reports).
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
basixCOMPAK 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.
- Dec 4, 2025Open, Classified
Inflation device handle may detach from the syringe during procedure.
Z-1123-2026 · Root cause: Process control · names 31 of these models · Recall details · FDA record ↗
- Aug 4, 2025Open, Classified
Hemostasis valve has a manufacturing defect and when used the valve cap may remain depressed, leading to potential leakage, which may result in procedure inconvenience and/or hemorrhage.
Z-0533-2026 · Root cause: Process change control · names 3 of these models · Recall details · FDA record ↗
Most reported basixCOMPAK problems
Device problems
- Detachment of Device or Device Component23
- Separation Problem8
- Inflation Problem7
- Material Separation4
- Mechanical Problem4
- Device Dislodged or Dislocated3
- Unintended Movement3
- Failure to Deflate2
Patient problems
- No Clinical Signs, Symptoms or Conditions32
- Cardiac Arrest1
- No Known Impact Or Consequence To Patient1
basixCOMPAK models
34 models, most reported first. Each model has its own page with its reports, recalls and device details.
- basixCOMPAK™ 00884450638385Syringe, Balloon Inflation, Exempt2 recalls4 reports
- basixCOMPAK™ 00884450638521Syringe, Balloon Inflation, Exempt2 recalls0 reports
- basixCOMPAK™ TSyringe, Balloon Inflation, Exempt2 recalls0 reports
- basixCOMPAK™ 00884450637524Syringe, Balloon Inflation, Exempt1 recall15 reports
- basixCOMPAK™ 00884450638323Syringe, Balloon Inflation, Exempt1 recall4 reports
- basixCOMPAK™ 00884450638347Syringe, Balloon Inflation, Exempt1 recall4 reports
- basixCOMPAK™ TSyringe, Balloon Inflation, Exempt1 recall2 reports
- basixCOMPAK™ 00884450638354Syringe, Balloon Inflation, Exempt1 recall1 report
- basixCOMPAK™ 00884450544570Syringe, Balloon Inflation, Exempt1 recall0 reports
- basixCOMPAK™ 00884450544587Syringe, Balloon Inflation, Exempt1 recall0 reports
- basixCOMPAK™ 00884450544594Syringe, Balloon Inflation, Exempt1 recall0 reports
- basixCOMPAK™ 00884450544617Syringe, Balloon Inflation, Exempt1 recall0 reports
- basixCOMPAK™ Initial ReleaseSyringe, Balloon Inflation, Exempt1 recall0 reports
- basixCOMPAK™ 00884450638101Syringe, Balloon Inflation, Exempt1 recall0 reports
- basixCOMPAK™ 00884450638316Syringe, Balloon Inflation, Exempt1 recall0 reports
- basixCOMPAK™ 00884450638378Syringe, Balloon Inflation, Exempt1 recall0 reports
- basixCOMPAK™ 00884450638392Syringe, Balloon Inflation, Exempt1 recall0 reports
- basixCOMPAK™ 00884450638408Syringe, Balloon Inflation, Exempt1 recall0 reports
- basixCOMPAK™ 00884450638415Syringe, Balloon Inflation, Exempt1 recall0 reports
- basixCOMPAK™ 00884450638422Syringe, Balloon Inflation, Exempt1 recall0 reports
- basixCOMPAK™ 00884450638439Syringe, Balloon Inflation, Exempt1 recall0 reports
- basixCOMPAK™ 00884450638446Syringe, Balloon Inflation, Exempt1 recall0 reports
- basixCOMPAK™ 00884450638453Syringe, Balloon Inflation, Exempt1 recall0 reports
- basixCOMPAK™ 00884450638460Syringe, Balloon Inflation, Exempt1 recall0 reports
- basixCOMPAK™ 00884450638477Syringe, Balloon Inflation, Exempt1 recall0 reports
- basixCOMPAK™ 00884450638484Syringe, Balloon Inflation, Exempt1 recall0 reports
- basixCOMPAK™ 00884450638491Syringe, Balloon Inflation, Exempt1 recall0 reports
- basixCOMPAK™Syringe, Balloon Inflation, Exempt1 recall0 reports
- basixCOMPAK™ 00884450638538Syringe, Balloon Inflation, Exempt1 recall0 reports
- basixCOMPAK™ 00884450645161Syringe, Balloon Inflation, Exempt1 recall0 reports
- basixCOMPAK™ TSyringe, Balloon Inflation, Exempt1 recall0 reports
- basixCOMPAK™ 00884450016756Syringe, balloon inflation2 reports
- basixCOMPAK™ 00884450498538Syringe, Balloon Inflation, Exempt1 report
- basixCOMPAK™ 00884450544501Syringe, Balloon Inflation, Exempt1 death1 report
Recent basixCOMPAK adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionSep 17, 2026Detachment of Device or Device Component
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50810344 ↗MalfunctionAug 11, 2026Contamination
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50211800 ↗MalfunctionJul 15, 2026Detachment of Device or Device Component
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25824876 ↗MalfunctionJun 26, 2026Detachment of Device or Device Component
CUSTOMER REPORTED THAT WHEN TRYING TO INFLATE TO THE WHITE ROTATING ARM IN THE MIDDLE, IT GOT DETACHED FROM THE TRANSPARENT BODY. NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25635651 ↗MalfunctionJun 25, 2026Detachment of Device or Device Component
CUSTOMER REPORTED WHEN PRESSING THE MIDDLE WHITE SWING ARM UPWARD, IT DETACHED FROM THE MIDDLE TRANSPARENT BARREL. NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25623044 ↗MalfunctionMay 14, 2026Material Separation
THE HANDLE DETACHED DURING USE ON A PATIENT. NO PATIENT INJURY OR MEDICAL INTERVENTION WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25176243 ↗MalfunctionMar 9, 2026Loose or Intermittent Connection; Detachment of Device or Device Component
A CUSTOMER ALLEGED DURING USE, THE INFLATION SYRINGE UNSCREWS. NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24550722 ↗MalfunctionFeb 12, 2026Inflation Problem; Detachment of Device or Device Component; Separation Problem
THE ACCOUNT ALLEGES THAT DURING THE PROCESS OF INFLATION, THE HANDLE WAS FOUND TO DETACH AND BECAME DISCONNECTED FROM THE DEVICE. A NEW DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24327160 ↗MalfunctionFeb 12, 2026Detachment of Device or Device Component
A CUSTOMER ALLEGED DURING A PROCEDURE IN THE CARDIOLOGY DEPARTMENT, THE HANDLE OF THE MERIT BASIXCOMPAK BROKE OFF. NO REPORTED INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24321743 ↗MalfunctionJan 28, 2026Inflation Problem; Detachment of Device or Device Component; Separation Problem
THE ACCOUNT ALLEGES THAT WHEN ATTEMPTING TO DEFLATE WITH THE INFLATION DEVICE, THE HANDLE SEPARATED FROM THE REST OF THE DEVICE. NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24199299 ↗MalfunctionJan 13, 2026Inflation Problem; Detachment of Device or Device Component; Separation Problem
THE ACCOUNT ALLEGES THAT THE RETAINER CAP OF THE INFLATION DEVICE WAS FOUND TO BE LOOSE. THIS MADE IT IMPOSSIBLE TO INFLATE THE DEVICE NORMALLY. NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24054291 ↗MalfunctionDec 23, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
A CUSTOMER ALLEGED A MERIT INFLATOR HANDLE DISCONNECTED AT THE SCREW THREAD. NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23877224 ↗MalfunctionDec 23, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
A CUSTOMER ALLEGED A MERIT INFLATOR HANDLE DISCONNECTED AT THE SCREW THREAD. NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23877223 ↗MalfunctionDec 15, 2025Inflation Problem; Detachment of Device or Device Component; Separation Problem; Inflation Problem; Detachment of Device or Device Component; Separation Problem
THE ACCOUNT ALLEGES THAT DURING THE PROCESS OF INFLATION, THE HANDLE WAS FOUND TO DETACH AND BECAME DISCONNECTED FROM THE DEVICE. NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23810607 ↗MalfunctionDec 15, 2025Inflation Problem; Detachment of Device or Device Component; Separation Problem; Inflation Problem; Detachment of Device or Device Component; Separation Problem
THE ACCOUNT ALLEGES THAT DURING THE PROCESS OF INFLATION, THE HANDLE WAS FOUND TO DETACH AND BECAME DISCONNECTED FROM THE DEVICE. THE DEVICE WAS REASSEMBLED TO COMPLETE THE PROCEDURE. NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23810385 ↗
Other Merit Medical Systems, Inc. products
- Aspira11 models · 36 reports · 10 recalls
- Impress145 models · 481 reports
- Monarch6 models · 37 reports · 7 recalls
- Bridge Prep Kit4 models · 6 reports · 3 recalls
- Prelude Roadster33 models · 1 reports · 3 recalls
- basixTOUCH6 models · 1 reports · 3 recalls
- Flex-Neck11 models · 21 reports · 2 recalls
- HeartSpan5 models · 10 reports · 2 recalls
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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