MISSIONRecalls & reported problems across all models
Bard Peripheral Vascular, Inc. · 20 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
3 open recalls name at least one MISSION model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 216
- Deaths reported
- 1
- Injuries reported
- 37
- Recalls
- 3
We found 20 models of MISSION by Bard Peripheral Vascular, Inc. in the FDA's device registry (GUDID). Together they are named in 216 adverse event reports in the FDA's MAUDE database, received between Mar 14, 2017 and Sep 29, 2026 — classified as 1 death, 37 injuries, 178 malfunctions.
The most frequently reported specific device problem is “Break” (53 reports).
3 FDA recall records name at least one of these models by its device identifier, 3 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
MISSION 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.
- Nov 8, 2023Open, Classified
The internal diameter of the coaxial cannula may be smaller or larger than the external diameter of the biopsy needle, and the length of the cannula may exceed the stated length on the label. As a result, the biopsy needle may not fit properly into the coaxial cannula, preventing access to the target tissue, which could lead to tissue injury, longer and repeat procedures.
Z-0643-2024 · Root cause: Process control · names 11 of these models · Recall details · FDA record ↗
- Apr 11, 2023Open, Classified
Coaxial cannula internal diameter and length of biopsy instruments exceed the external diameter and length of the biopsy needle, prohibiting the biopsy needle from properly fitting into the coaxial cannula and accessing the target tissue, which could lead to procedure delay, and insufficient sample acquisition requiring a repeat procedure.
Z-1564-2023 · Root cause: Mixed-up of materials/components · names 2 of these models · Recall details · FDA record ↗
- Feb 28, 2023Open, Classified
The external diameter of the biopsy instrument is larger than the internal diameter of the coaxial needle, which could lead to: 1) Procedural delay, 2) Requirement of an additional device, 3), Needle tip breakage, if used despite incompatibility.
Z-1260-2023 · Root cause: Mixed-up of materials/components · names 2 of these models · Recall details · FDA record ↗
Most reported MISSION problems
Device problems
- Break53
- Device Markings/Labelling Problem44
- Material Twisted/Bent44
- Difficult to Remove40
- Detachment of Device or Device Component30
- Device-Device Incompatibility24
- Device Contamination with Chemical or Other Material11
- Adverse Event Without Identified Device or Use Problem10
Patient problems
- No Clinical Signs, Symptoms or Conditions161
- No Consequences Or Impact To Patient12
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available11
- Foreign Body In Patient9
- Hemorrhage/Blood Loss/Bleeding5
- Injury5
- Pneumothorax5
- Device Embedded In Tissue or Plaque4
MISSION models
20 models, most reported first. Each model has its own page with its reports, recalls and device details.
- MISSION 1816MSKINSTRUMENT, BIOPSY2 recalls1 death41 reports
- MISSION 2016MSKINSTRUMENT, BIOPSY2 recalls38 reports
- MISSION 2010MSKINSTRUMENT, BIOPSY2 recalls13 reports
- MISSION 1610MSKINSTRUMENT, BIOPSY2 recalls4 reports
- MISSION 1410MSKINSTRUMENT, BIOPSY1 recall13 reports
- MISSION 1810MSKINSTRUMENT, BIOPSY1 recall11 reports
- MISSION 1820MSKINSTRUMENT, BIOPSY1 recall11 reports
- MISSION 2020MSKINSTRUMENT, BIOPSY1 recall5 reports
- MISSION 1616MSKINSTRUMENT, BIOPSY1 recall2 reports
- MISSION 1825MSKINSTRUMENT, BIOPSY1 recall1 report
- MISSION 1416MSKINSTRUMENT, BIOPSY1 recall0 reports
- MISSION 2020MSINSTRUMENT, BIOPSY24 reports
- MISSION 1410MSINSTRUMENT, BIOPSY15 reports
- MISSION 1610MSINSTRUMENT, BIOPSY11 reports
- MISSION 1810MSINSTRUMENT, BIOPSY8 reports
- MISSION 1816MSINSTRUMENT, BIOPSY8 reports
- MISSION 1616MSINSTRUMENT, BIOPSY6 reports
- MISSION 2010MSINSTRUMENT, BIOPSY3 reports
- MISSION 1416MSINSTRUMENT, BIOPSY1 report
- MISSION 1820MSINSTRUMENT, BIOPSY1 report
Recent MISSION adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionSep 29, 2026Break; Material Twisted/Bent
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50932698 ↗MalfunctionSep 29, 2026Detachment of Device or Device Component
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50929320 ↗InjuryJul 8, 2026Adverse Event Without Identified Device or Use Problem
A patient underwent a liver biopsy procedure using a Mission instrument. Following the procedure, the patient experienced severe bleeding and significant blood loss, estimated at approximately six liters. It was further reported that the patient experienced a life threatening hemorrhagic event and required emergency intervention, including surgery and embolization, to control the bleeding. The current status of the patient is unknown.
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 25743621 ↗MalfunctionJul 3, 2026Contamination; Device Damaged Prior to Receipt by User
A PATIENT UNDERWENT A BIOPSY PROCEDURE USING THE MISSION DEVICE. PRIOR TO THE PROCEDURE, THE DEVICE SOAKED IN SOME SORT OF LIQUID. FURTHER IT WAS REPORTED THAT NO LONGER STERILE. THERE WAS NO PATIENT CONTACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25701923 ↗MalfunctionMay 5, 2026
PATIENT CAME IN FOR AN OUTPATIENT CT GUIDED LUNG BIOPSY. DR. [REDACTED] USED BARD BIOPSY NEEDLE AS HE NORMALLY DOES. HE WAS ABLE TO GET SOME SAMPLES AT FIRST BUT ON HIS NEXT ATTEMPT HE SAID THE NEEDLE WAS NOT GOING IN. WE STOPPED GETTING SAMPLES, DR [REDACTED] PULLED THE NEEDLE OUT, ANYWAY WE HAD ENOUGH SAMPLES ACCORDING TO THE PATHOLOGIST. POST PROCEDURE SCAN WAS DONE, AND IT SHOWED SMALL PNEUMOTHORAX AND A NEEDLE SEGMENT WAS NOTED ON WHERE THE BIOPSY SITE WAS. INCIDENT EXPLAINED TO PATIENT AND WIFE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25081076 ↗MalfunctionApr 15, 2026Failure to Fire; Detachment of Device or Device Component
ON (B)(6) 2025, A PATIENT UNDERWENT AN ULTRASOUND GUIDED LIVER BIOPSY PROCEDURE THROUGH NORMAL DENSITY TISSUE USING A MISSION BIOPSY KIT. PRIOR TO THE PROCEDURE, THE OUTER CANNULA COULDN'T BE FIRED. THE PROCEDURE WAS COMPLETED BY ANOTHER DEVICE. THERE WAS NO PATIENT CONTACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24884821 ↗InjuryMar 5, 2026Break
ON (B)(6) 2026, A PATIENT UNDERWENT A BIOPSY PROCEDURE BY USING MISSION KIT. IT WAS REPORTED THAT DURING THE PROCEDURE THE NEEDLE ALLEGEDLY BROKE IN THE LESION. FURTHER IT WAS REPORTED THAT THE BROKEN NEEDLE REQUIRED REMOVAL IN IR. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 24516415 ↗MalfunctionFeb 26, 2026Failure to Fire
ON (B)(6) 2026, A PATIENT UNDERWENT AN ULTRASOUND-GUIDED KIDNEY BIOPSY THROUGH NORMAL DENSITY TISSUE USING THE MISSION INSTRUMENT. IT WAS REPORTED THAT DURING THE PROCEDURE, THE OUTER CANNULA ALLEGEDLY CAN'T BE FIRED. NO COAXIAL WAS USED, AND THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24451414 ↗MalfunctionFeb 24, 2026Self-Activation or Keying
ON (B)(6) 2026, A PATIENT UNDERWENT AN ULTRASOUND GUIDED KIDNEY BIOPSY PROCEDURE THROUGH NORMAL DENSITY TISSUE USING A MISSION INSTRUMENT. AFTER FIRING THE DEVICE, AN ISSUE OCCURRED WITH THE INSTRUMENTS LOCKING SYSTEM FOLLOWING PUSHING THE INNER NEEDLE TO RETRIEVE THE SPECIMEN. SLIGHT NEEDLE MOVEMENT OCCURRED CRUSHING THE SPECIMEN. IT WAS FURTHER REPORTED THAT, WITHOUT PRESSING THE TRIGGER BUTTON, THE OUTER CANNULA RELEASED FROM THE PRIME POSITION. THE PROCEDURE WAS COMPLETED BY ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24427087 ↗MalfunctionFeb 10, 2026Detachment of Device or Device Component
ON (B)(6) 2025, A PATIENT WAS GETTING PREPARED FOR A BIOPSY PROCEDURE USING THE MISSION KIT. PRIOR TO THE PROCEDURE, IT WAS REPORTED THAT THE DEVICE HAD A PLASTIC CAP WHICH WAS ALLEGEDLY BROKE OFF. THERE WAS NO PATIENT CONTACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24302203 ↗MalfunctionFeb 10, 2026Device Markings/Labelling Problem
A PATIENT WAS GETTING PREPARED FOR A BIOPSY PROCEDURE USING THE MISSION BIOPSY DEVICE WAS FOUND TO HAVE TWO DIFFERENT LABELS APPLIED, ONE FOR REF 1610MS (BATCH 0001633398) AND ANOTHER FOR REF 1616MS (BATCH 0001637938). IT WAS REPORTED THAT THE PHYSICAL PRODUCT INSIDE THE PACKAGING WAS 1616MS, WHICH DOES NOT MATCH THE INVOICED OR EXPECTED. THERE WAS NO PATIENT CONTACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24302072 ↗MalfunctionFeb 10, 2026Device Markings/Labelling Problem
A PATIENT WAS GETTING PREPARED FOR A BIOPSY PROCEDURE USING THE MISSION BIOPSY DEVICE WAS FOUND TO HAVE TWO DIFFERENT LABELS APPLIED, ONE FOR REF 1610MS (BATCH 0001633398) AND ANOTHER FOR REF 1616MS (BATCH 0001637938). IT WAS REPORTED THAT THE PHYSICAL PRODUCT INSIDE THE PACKAGING WAS 1616MS, WHICH DOES NOT MATCH THE INVOICED OR EXPECTED. THERE WAS NO PATIENT CONTACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24302070 ↗MalfunctionFeb 10, 2026Device Markings/Labelling Problem
A PATIENT WAS GETTING PREPARED FOR A BIOPSY PROCEDURE USING THE MISSION BIOPSY DEVICE WAS FOUND TO HAVE TWO DIFFERENT LABELS APPLIED, ONE FOR REF 1610MS (BATCH 0001633398) AND ANOTHER FOR REF 1616MS (BATCH 0001637938). IT WAS REPORTED THAT THE PHYSICAL PRODUCT INSIDE THE PACKAGING WAS 1616MS, WHICH DOES NOT MATCH THE INVOICED OR EXPECTED. THERE WAS NO PATIENT CONTACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24302067 ↗MalfunctionFeb 10, 2026Device Markings/Labelling Problem
A PATIENT WAS GETTING PREPARED FOR A BIOPSY PROCEDURE USING THE MISSION BIOPSY DEVICE WAS FOUND TO HAVE TWO DIFFERENT LABELS APPLIED, ONE FOR REF 1610MS (BATCH 0001633398) AND ANOTHER FOR REF 1616MS (BATCH 0001637938). IT WAS REPORTED THAT THE PHYSICAL PRODUCT INSIDE THE PACKAGING WAS 1616MS, WHICH DOES NOT MATCH THE INVOICED OR EXPECTED. THERE WAS NO PATIENT CONTACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24301976 ↗MalfunctionFeb 10, 2026Device Markings/Labelling Problem
A PATIENT WAS GETTING PREPARED FOR A BIOPSY PROCEDURE USING THE MISSION BIOPSY DEVICE WAS FOUND TO HAVE TWO DIFFERENT LABELS APPLIED, ONE FOR REF 1610MS (BATCH 0001633398) AND ANOTHER FOR REF 1616MS (BATCH 0001637938). IT WAS REPORTED THAT THE PHYSICAL PRODUCT INSIDE THE PACKAGING WAS 1616MS, WHICH DOES NOT MATCH THE INVOICED OR EXPECTED. THERE WAS NO PATIENT CONTACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24301971 ↗
Other Bard Peripheral Vascular, Inc. products
- MAX-CORE11 models · 8,845 reports · 1 recall
- DENALI Vena Cava Filter2 models · 1,021 reports
- MAGNUM19 models · 571 reports · 1 recall
- Conquest32 models · 560 reports
- Ultraverse RX56 models · 536 reports
- Fluency Endovascular Stent Graft51 models · 532 reports
- Atlas Gold33 models · 427 reports
- Ultraverse 035 PTA Dilatation Catheter92 models · 393 reports
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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