AchieveRecalls & reported problems across all models
Merit Medical Systems, Inc. · 12 models in the FDA device registry
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 100
- Deaths reported
- 0
- Injuries reported
- 5
- Recalls
- 0
We found 12 models of Achieve by Merit Medical Systems, Inc. in the FDA's device registry (GUDID). Together they are named in 100 adverse event reports in the FDA's MAUDE database, received between Sep 29, 2022 and Sep 24, 2026 — classified as 5 injuries, 95 malfunctions.
The most frequently reported specific device problem is “Failure to Fire” (66 reports).
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
Most reported Achieve problems
Device problems
- Failure to Fire66
- Failure to Obtain Sample20
- Patient Device Interaction Problem9
- Difficult or Delayed Activation2
- Insufficient Device Problem Information2
- Activation Failure1
- Activation Problem1
- Activation, Positioning or Separation Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions97
- Hemorrhage/Blood Loss/Bleeding3
- Pneumothorax1
Achieve models
12 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Achieve® 10884450443696INSTRUMENT, BIOPSY56 reports
- Achieve® 10884450443733INSTRUMENT, BIOPSY19 reports
- Achieve® 10884450443757INSTRUMENT, BIOPSY7 reports
- Achieve® 10884450443931INSTRUMENT, BIOPSY5 reports
- Achieve® 10884450443948INSTRUMENT, BIOPSY4 reports
- Achieve® 10884450443702INSTRUMENT, BIOPSY2 reports
- Achieve® 10884450443740INSTRUMENT, BIOPSY2 reports
- Achieve® 10884450443764Instrument, biopsy1 report
- Achieve® 10884450443788INSTRUMENT, BIOPSY1 report
- Achieve® 10884450443962INSTRUMENT, BIOPSY1 report
- Achieve® 10884450444327INSTRUMENT, BIOPSY1 report
- Achieve® 10884450444433INSTRUMENT, BIOPSY1 report
Recent Achieve adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
InjurySep 24, 2026Insufficient Device Problem Information
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 50892149 ↗InjurySep 24, 2026Insufficient Device Problem Information
Patient problems: Hemorrhage/Blood Loss/Bleeding; Pneumothorax
MAUDE report 50892111 ↗MalfunctionSep 21, 2026Failure to Obtain Sample
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50848483 ↗MalfunctionSep 15, 2026Failure to Obtain Sample
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50781547 ↗MalfunctionSep 10, 2026Failure to Obtain Sample
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50720157 ↗MalfunctionMay 21, 2026Failure to Obtain Sample
IT WAS REPORTED THAT DURING MICRO-GUIDED BIOPSY, NO TISSUE CORE WAS FOUND IN THE SAMPLING SLOT AFTER THE NEEDLE WAS WITHDRAWN FROM THE PATIENT. A BACK-UP DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT INJURY, MEDICAL OR SURGICAL INTERVENTION WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25246218 ↗MalfunctionMay 7, 2026Failure to Obtain Sample
THE ACCOUNT ALLEGES THAT WHEN ATTEMPTING TO TAKE BIOPSIES THE BIOPSY DEVICE FAILED TO COLLECT A SAMPLE. NO PATIENT INJURY TO REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25117168 ↗MalfunctionMar 26, 2026Patient Device Interaction Problem
DURING A BREAST BIOPSY, THE BREAST SURGEON WAS UNABLE TO RETRIEVE ANY TISSUE SAMPLES DESPITE MULTIPLE ATTEMPTS. THE BREAST SURGEON PROMPTLY REQUESTED A REPLACEMENT TO COMPLETE THE PROCEDURE. NO REPORTED INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24698763 ↗MalfunctionMar 26, 2026Patient Device Interaction Problem
DURING A BREAST BIOPSY, THE BREAST SURGEON WAS UNABLE TO RETRIEVE ANY TISSUE SAMPLES DESPITE MULTIPLE ATTEMPTS. THE BREAST SURGEON PROMPTLY REQUESTED A REPLACEMENT TO COMPLETE THE PROCEDURE. NO REPORTED INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24698755 ↗MalfunctionMar 26, 2026Patient Device Interaction Problem
DURING A BREAST BIOPSY, THE BREAST SURGEON WAS UNABLE TO RETRIEVE ANY TISSUE SAMPLES DESPITE MULTIPLE ATTEMPTS. THE BREAST SURGEON PROMPTLY REQUESTED A REPLACEMENT TO COMPLETE THE PROCEDURE. NO REPORTED INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24698752 ↗MalfunctionMar 26, 2026Patient Device Interaction Problem
DURING A PROCEDURE, THE PHYSICIAN FOUND A DEFECT IN THE SPRING AND WAS UNABLE TO COLLECT THE SAMPLE. THE PROCEDURE WAS COMPLETED WITH A NEW PRODUCT. NO PATIENT INJURY OR HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24698749 ↗MalfunctionMar 11, 2026Patient Device Interaction Problem
DURING A BREAST BIOPSY WITH ULTRASOUND GUIDANCE, THE HEALTHCARE PROVIDER WAS UNABLE TO DRAW BACK TO RETRIEVE SAMPLE FROM NEEDLE. TRIED AGAIN ONCE BIOPSY WAS COMPLETE, AND PT HAD LEFT THE ROOM AND WAS ABLE TO FORCE THE SAMPLE FROM THE NEEDLE. NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24575387 ↗MalfunctionMar 3, 2026Failure to Obtain Sample; Failure to Fire
THE ACCOUNT ALLEGES THAT WHEN ATTEMPTING TO TAKE BIOPSIES THE BIOPSY DEVICE FAILED TO COLLECT A SAMPLE. NO PATIENT INJURY TO REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24502979 ↗MalfunctionMar 3, 2026Failure to Obtain Sample; Failure to Fire
THE ACCOUNT ALLEGES THAT WHEN ATTEMPTING TO TAKE BIOPSIES THE BIOPSY DEVICE FAILED TO COLLECT A SAMPLE. NO PATIENT INJURY TO REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24502288 ↗MalfunctionFeb 18, 2026Failure to Obtain Sample
THE ACCOUNT ALLEGES THAT WHEN ATTEMPTING TO CAPTURE A BIOPSY SAMPLE NO SAMPLE COULD BE OBTAINED. A NEW DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24378123 ↗
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
- basixCOMPAK34 models · 34 reports · 2 recalls
- Flex-Neck11 models · 21 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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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