IMAGER IIRecalls & reported problems across all models
Boston Scientific Corporation · 47 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
1 open recall names at least one IMAGER II model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 119
- Deaths reported
- 3
- Injuries reported
- 57
- Recalls
- 1
We found 47 models of IMAGER II by Boston Scientific Corporation in the FDA's device registry (GUDID). Together they are named in 119 adverse event reports in the FDA's MAUDE database, received between Nov 9, 2017 and Dec 19, 2025 — classified as 3 deaths, 57 injuries, 59 malfunctions.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (47 reports).
1 FDA recall record name at least one of these models by its device identifier, 1 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
IMAGER II 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.
- Aug 24, 2026Open, Classified
Tip may fracture or detach, leading to device fragments remaining within the patient or migrating through the vasculature. Patient impact may include prolonged procedure or life-threatening embolism.
Z-3214-2026 · Root cause: Process control · names 26 of these models · Recall details · FDA record ↗
Most reported IMAGER II problems
Device problems
- Adverse Event Without Identified Device or Use Problem64
- Detachment of Device or Device Component47
- Material Integrity Problem8
- Device Contamination with Chemical or Other Material3
- Difficult to Remove2
- Entrapment of Device2
- Break1
- Material Puncture/Hole1
Patient problems
- No Patient Involvement33
- No Consequences Or Impact To Patient21
- No Clinical Signs, Symptoms or Conditions17
- Device Embedded In Tissue or Plaque8
- Sepsis8
- Renal Failure5
- Urinary Tract Infection5
- Hemorrhage/Blood Loss/Bleeding4
IMAGER II models
47 models, most reported first. Each model has its own page with its reports, recalls and device details.
- IMAGER™ II M001314050CATHETER, INTRAVASCULAR, DIAGNOSTIC1 recall1 death9 reports
- IMAGER™ II M001314060CATHETER, INTRAVASCULAR, DIAGNOSTIC1 recall8 reports
- IMAGER™ II M001314670CATHETER, INTRAVASCULAR, DIAGNOSTIC1 recall7 reports
- IMAGER™ II M001314140CATHETER, INTRAVASCULAR, DIAGNOSTIC1 recall4 reports
- IMAGER™ II M001314580CATHETER, INTRAVASCULAR, DIAGNOSTIC1 recall4 reports
- IMAGER™ II M001314340CATHETER, INTRAVASCULAR, DIAGNOSTIC1 recall2 reports
- IMAGER™ II M001314660CATHETER, INTRAVASCULAR, DIAGNOSTIC1 recall2 reports
- IMAGER™ II M001314760CATHETER, INTRAVASCULAR, DIAGNOSTIC1 recall2 reports
- IMAGER™ II M001314100CATHETER, INTRAVASCULAR, DIAGNOSTIC1 recall1 report
- IMAGER™ II M001314320CATHETER, INTRAVASCULAR, DIAGNOSTIC1 recall1 report
- IMAGER™ II M001314000CATHETER, INTRAVASCULAR, DIAGNOSTIC1 recall0 reports
- IMAGER™ II M001314010CATHETER, INTRAVASCULAR, DIAGNOSTIC1 recall0 reports
- IMAGER™ II M001314020CATHETER, INTRAVASCULAR, DIAGNOSTIC1 recall0 reports
- IMAGER™ II M001314030CATHETER, INTRAVASCULAR, DIAGNOSTIC1 recall0 reports
- IMAGER™ II M001314040CATHETER, INTRAVASCULAR, DIAGNOSTIC1 recall0 reports
- IMAGER™ II M001314080CATHETER, INTRAVASCULAR, DIAGNOSTIC1 recall0 reports
- IMAGER™ II M001314150CATHETER, INTRAVASCULAR, DIAGNOSTIC1 recall0 reports
- IMAGER™ II M001314300CATHETER, INTRAVASCULAR, DIAGNOSTIC1 recall0 reports
- IMAGER™ II M001314350CATHETER, INTRAVASCULAR, DIAGNOSTIC1 recall0 reports
- IMAGER™ II M001314360CATHETER, INTRAVASCULAR, DIAGNOSTIC1 recall0 reports
- IMAGER™ II M001314520CATHETER, INTRAVASCULAR, DIAGNOSTIC1 recall0 reports
- IMAGER™ II M001314620CATHETER, INTRAVASCULAR, DIAGNOSTIC1 recall0 reports
- IMAGER™ II M001314770CATHETER, INTRAVASCULAR, DIAGNOSTIC1 recall0 reports
- IMAGER™ II M001314820CATHETER, INTRAVASCULAR, DIAGNOSTIC1 recall0 reports
- IMAGER™ II M001314860CATHETER, INTRAVASCULAR, DIAGNOSTIC1 recall0 reports
- IMAGER™ II M001314880CATHETER, INTRAVASCULAR, DIAGNOSTIC1 recall0 reports
- Imager II M0064003000CATHETER, UROLOGICAL2 deaths36 reports
- IMAGER™ II M001315150CATHETER, INTRAVASCULAR, DIAGNOSTIC12 reports
- IMAGER™ II M001314830CATHETER, INTRAVASCULAR, DIAGNOSTIC6 reports
- IMAGER™ II M001314120CATHETER, INTRAVASCULAR, DIAGNOSTIC3 reports
- IMAGER™ II M001314590CATHETER, INTRAVASCULAR, DIAGNOSTIC3 reports
- IMAGER™ II M001316090CATHETER, INTRAVASCULAR, DIAGNOSTIC3 reports
- IMAGER™ II M001316670CATHETER, INTRAVASCULAR, DIAGNOSTIC2 reports
- IMAGER™ II M001314330CATHETER, INTRAVASCULAR, DIAGNOSTIC1 report
- Imager™ II M001315010CATHETER, INTRAVASCULAR, DIAGNOSTIC1 report
- IMAGER™ II M001315050CATHETER, INTRAVASCULAR, DIAGNOSTIC1 report
- Imager™ II M001315090CATHETER, INTRAVASCULAR, DIAGNOSTIC1 report
- IMAGER™ II M001315130CATHETER, INTRAVASCULAR, DIAGNOSTIC1 report
- IMAGER™ II M001315140CATHETER, INTRAVASCULAR, DIAGNOSTIC1 report
- IMAGER™ II M001315200CATHETER, INTRAVASCULAR, DIAGNOSTIC1 report
- Imager™ II M001315250CATHETER, INTRAVASCULAR, DIAGNOSTIC1 report
- Imager™ II M001315260CATHETER, INTRAVASCULAR, DIAGNOSTIC1 report
- IMAGER™ II M001315310CATHETER, INTRAVASCULAR, DIAGNOSTIC1 report
- IMAGER™ II M001316060CATHETER, INTRAVASCULAR, DIAGNOSTIC1 report
- IMAGER™ II M001316070CATHETER, INTRAVASCULAR, DIAGNOSTIC1 report
- Imager II M0064003030CATHETER, UROLOGICAL1 report
- Imager II M0064005030CATHETER, UROLOGICAL1 report
Recent IMAGER II adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
InjuryDec 19, 2025Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem; Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT ADDITIONAL INTERVENTION WAS REQUIRED TO REMOVE A DETACHED TIP. AN IMAGER II ANGIOGRAPHIC CATHETER WAS SELECTED FOR USE IN EMBOLIZATION OF THE RENAL ARTERY. THE CONDITION OF THE VESSEL WAS A STRAIGHTFORWARD RENAL ARTERY. WHILE INSERTING THE CATHETER INTO THE PATIENT, THE DISTAL TIP DETACHED. THERE WAS NO RESISTANCE NOTED DURING USE OF THE DEVICE. THE TIP MIGRATED TOWARD THE AORTA. AN INITIAL ATTEMPT AT RETRIEVAL WAS UNSUCCESSFUL BECAUSE THE TIP HAD BECOME ADHERED TO THE AORTIC WALL. A NEW VASCULAR ACCESS SITE WAS CREATED, AND A NEW SHEATH WAS USED FROM THE NEW SITE. WHEN THE DETACHED TIP EVENTUALLY MOVED, IT WAS REMOVED FROM THE LOWER PART OF THE LEG VIA SNARE. WHEN THE TIP WAS EXTRACTED FROM THE SHEATH, IT HAD BROKEN INTO SMALL FRAGMENTS. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THE EVENT. THE PATIENT WAS STABLE FOLLOWING THE PROCEDURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23853499 ↗MalfunctionOct 28, 2025Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem; Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT A TIP DETACHMENT OCCURRED. AN IMAGER II ANGIOGRAPHIC CATHETER WAS SELECTED FOR USE. THE CATHETER WAS FLUSHED DURING PREPARATION, HOWEVER, THE TIP DETACHED INTO TWO PIECES. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THE EVENT. IT WAS FURTHER REPORTED THAT HYDROGEN PEROXIDE WAS USED TO CLEAN THE CATHETERIZATION LAB ONCE A MONTH.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23407636 ↗MalfunctionOct 28, 2025Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem; Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT A TIP DETACHMENT OCCURRED. AN IMAGER II ANGIOGRAPHIC CATHETER WAS SELECTED FOR USE. THE CATHETER WAS FLUSHED DURING PREPARATION, HOWEVER, THE TIP DETACHED INTO TWO PIECES. THE SAME EVENT OCCURRED AGAIN WITH ANOTHER IMAGER II ANGIOGRAPHIC CATHETER. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THE EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23407634 ↗InjuryAug 19, 2025Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem; Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE CATHETER TIP DISLODGED, AND A PORTION REMAINED IN THE ARTERY. AN IMAGER II/5/BERN/100/038 BX5 ANGIOGRAPHIC CATHETER WAS SELECTED FOR A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY PROCEDURE IN THE SUPERFICIAL FEMORAL AND PROXIMAL POPLITEAL ARTERIES. AFTER DEPLOYMENT OF THE CATHETER, IT WAS NOTED THAT THE PROXIMAL TIP DISLODGED AND REMAINED IN THE ARTERY. AFTER REMOVAL OF THE CATHETER, IT WAS INSPECTED, AND IT WAS NOTED THAT THE PROXIMAL TIP HAD BROKEN INTO THREE SEPARATE PIECES. THE DISLODGED PIECE IN THE PATIENT COULD NOT BE REMOVED AFTER MANY ATTEMPTS. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THE PATIENT CONDITION FOLLOWING THE PROCEDURE WAS STABLE. IT WAS FURTHER REPORTED THAT THE HUMIDITY OF THE CATH LAB WAS 60-65%. HYDROGEN PEROXIDE WAS USED TO CLEAN THE LAB MONTHLY FOR FUMIGATION.
Patient problems: Foreign Body In Patient
MAUDE report 22841615 ↗InjuryJun 26, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT THE TIP DETACHED AND WAS LEFT INSIDE THE PATIENT. ON (B)(6) 2024, THE PATIENT WAS ADMITTED TO THE HOSPITAL DUE TO DIZZINESS AND CEREBRAL VASCULAR STENOSIS. ON (B)(6) 2024, AN IMAGER II ANGIOGRAPHIC CATHETER WAS SELECTED FOR USE IN TOTAL CEREBRAL ANGIOGRAPHY, WHICH WAS PERFORMED UNDER LOCAL ANESTHESIA. A 0.035, 150CM ZIPWIRE GUIDEWIRE WAS USED TO DELIVER THE CATHETER TO THE AORTIC ARCH. THE PHYSICIAN STARTED ROTATING THE IMAGER II CATHETER TO GET IT INTO THE LEFT COMMON CAROTID ARTERY. AFTER A FEW ATTEMPTS, IT WAS NOTED THAT THE CATHETER'S TIP WAS ABNORMAL, AND THE TIP DETACHED AND BEGAN MOVING TOWARD THE DESCENDING AORTA. THE CATHETER WAS IMMEDIATELY REMOVED, AND OUTSIDE THE PATIENT IT WAS OBSERVED THAT THE TIP HAD FRACTURED. UPON IMMEDIATE EXAMINATION, IT WAS DETERMINED THAT THE TIP WAS LOCATED IN THE LEFT RENAL ARTERY BRANCH. THE PATIENT WAS ASYMPTOMATIC. THE FRAGMENT WAS APPROXIMATELY 1CM AND REMAINED IN THE PATIENT'S LEFT KIDNEY. NO ATTEMPTS TO REMOVE THE FRAGMENT WERE MADE. THE PROCEDURE WAS NOT COMPLETED DUE TO THIS EVENT. THE PATIENT WAS IN STABLE CONDITION AND WAS DISCHARGED ON (B)(6) 2024.
Patient problems: Foreign Body In Patient
MAUDE report 19619618 ↗MalfunctionMay 22, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT TIP DETACHMENT OCCURRED. THE TARGET LESION WAS LOCATED IN A MODERATELY TORTUOUS AND NON-CALCIFIED VESSEL. A 5F IMAGER II DIAGNOSTIC CATHETER WAS SELECTED FOR USE. DURING THE PROCEDURE, THE CATHETER TIP BROKE WHEN THE DEVICE WAS MOVED TO THE DIAGNOSTIC ZONE. THE PHYSICIAN MANAGED TO PULL IT OUT SAFELY FROM THE PATIENT. NO COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19372274 ↗MalfunctionAug 16, 2023Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT TIP DETACHMENT OCCURRED. AN IMAGER II WAS SELECTED FOR USE IN A DIGITAL SUBTRACTION ANGIOGRAPHY PROCEDURE. DURING THE PROCEDURE, THE CATHETER WAS KINKED, AND TIP WAS BROKEN WHEN IT WAS ADVANCED TO THE CAROTID ARTERY. THE DEVICE, INCLUDING THE BROKEN PARTS WERE ABLE TO BE REMOVED INTO THE SHEATH AND FROM THE PATIENT'S BODY. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17560818 ↗InjuryApr 13, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
NOTE: THIS REPORT PERTAINS TO ONE OF THE FOUR DEVICES USED IN THE SAME PATIENT AND PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN IMAGE II, NEPHROMAX BALLOON, PERCUTANEOUS ACCESS NEEDLE AND 8/10 DILATOR SHEATH SET WERE USED DURING A PERCUTANEOUS NEPHROLITHOTOMY (PCNL) PROCEDURE PERFORMED IN (B)(6) 2016. THE PATIENT EXPERIENCED PAIN AND WAS READMITTED. IN THE PHYSICIAN'S ASSESSMENT THE EVENT WAS NOT RELATED TO THE IMAGER II AND 8/10 DILATOR SHEATH SET BUT WAS CAUSALLY RELATED TO THE PROCEDURE. IN THE PHYSICIAN'S ASSESSMENT THE EVENT WAS PROBABLY RELATED TO THE NEPHROMAX BALLOON AND PERCUTANEOUS ACCESS NEEDLE BUT WAS CAUSALLY RELATED TO THE PROCEDURE.
Patient problems: Pain
MAUDE report 16732459 ↗InjuryApr 13, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
NOTE: THIS REPORT PERTAINS TO ONE OF FOUR DEVICES USED IN THE SAME PATIENT AND PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN IMAGER II, NEPHROMAX BALLOON, PERCUTANEOUS ACCESS NEEDLE AND 8/10 DILATOR WERE USED DURING A PERCUTANEOUS NEPHROLITHOTOMY (PCNL) PROCEDURE PERFORMED IN (B)(6) 2016. THE PATIENT EXPERIENCED SEPSIS AND WAS ADMITTED TO THE INTENSIVE CARE UNIT (ICU) WHEREIN SHE WAS TREATED WITH ANTIBIOTICS. IN THE PHYSICIAN'S ASSESSMENT THE EVENT WAS NOT RELATED TO THE IMAGER II AND 8/10 DILATOR SHEATH SET BUT WAS CAUSALLY RELATED TO THE PROCEDURE. IN THE PHYSICIAN'S ASSESSMENT THE EVENT WAS PROBABLY RELATED TO THE NEPHROMAX BALLOON AND PERCUTANEOUS ACCESS NEEDLE BUT WAS CAUSALLY RELATED TO THE PROCEDURE.
Patient problems: Sepsis
MAUDE report 16732228 ↗InjuryApr 13, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
NOTE: THIS REPORT PERTAINS TO ONE OF FOUR DEVICES USED IN THE SAME PATIENT AND PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN IMAGER II, NEPHROMAX BALLOON, PERCUTANEOUS ACCESS NEEDLE AND 8/10 DILATOR SHEATH SET WERE USED DURING A PERCUTANEOUS NEPHROLITHOTOMY (PCNL) PROCEDURE PERFORMED IN (B)(6) 2016. THE PATIENT EXPERIENCED WOUND INFECTION AND WAS TREATED WITH WOUND PACKING AND ANTIBIOTICS. IN THE PHYSICIAN'S ASSESSMENT THE EVENT WAS NOT RELATED TO THE IMAGER II AND 8/10 DILATOR SHEATH SET BUT WAS CAUSALLY RELATED TO THE PROCEDURE. IN THE PHYSICIAN'S ASSESSMENT THE EVENT WAS PROBABLY RELATED TO THE NEPHROMAX BALLOON AND PERCUTANEOUS ACCESS NEEDLE BUT WAS CAUSALLY RELATED TO THE PROCEDURE.
Patient problems: Post Operative Wound Infection
MAUDE report 16731557 ↗InjuryApr 13, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
NOTE: THIS REPORT PERTAINS TO ONE OF FOUR DEVICES USED IN THE SAME PATIENT AND PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN IMAGER II, NEPHROMAX BALLOON, 8/10 DILATOR SHEATH SET AND PERCUTANEOUS ACCESS NEEDLE WERE USED DURING A PERCUTANEOUS NEPHROLITHOTOMY (PCNL) PROCEDURE PERFORMED IN (B)(6) 2016. THE PATIENT EXPERIENCED URINOMA AND HAD A CYSTO STENT PLACED TO HELP DRAIN THE URINOMA. IN THE PHYSICIAN'S ASSESSMENT THE EVENT WAS NOT RELATED TO THE IMAGER II, 8/10 DILATOR SHEATH SET AND PERCUTANEOUS ACCESS NEEDLE BUT WAS CAUSALLY RELATED TO THE PROCEDURE. IN THE PHYSICIAN'S ASSESSMENT THE EVENT WAS PROBABLY RELATED TO THE NEPHROMAX BALLOON BUT WAS CAUSALLY RELATED TO THE PROCEDURE.
Patient problems: Perforation
MAUDE report 16731414 ↗InjuryApr 11, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
NOTE: THIS REPORT PERTAINS TO ONE OF FOUR DEVICES USED IN THE SAME PATIENT AND PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN IMAGER II, NEPHROMAX BALLOON, PERCUTANEOUS ACCESS NEEDLE AND 8/10 DILATOR SHEATH SET WERE USED DURING A PERCUTANEOUS NEPHROLITHOTOMY (PCNL) PROCEDURE PERFORMED IN (B)(6) 2016. THE PATIENT EXPERIENCED SEPTIC SHOCK AND WAS ADMITTED TO THE INTENSIVE CARE UNIT (ICU) AND TREATED WITH INTRAVENOUS (IV) ANTIBIOTICS. IN THE PHYSICIAN'S ASSESSMENT THE EVENT WAS NOT RELATED TO THE IMAGER II, PERCUTANEOUS ACCESS NEEDLE AND 8/10 DILATOR SHEATH SET BUT WAS CAUSALLY RELATED TO THE PROCEDURE. IN THE PHYSICIAN'S ASSESSMENT THE EVENT WAS PROBABLY RELATED TO THE NEPHROMAX BUT WAS CAUSALLY RELATED TO THE PROCEDURE.
Patient problems: Septic Shock
MAUDE report 16714589 ↗InjuryApr 11, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
NOTE: THIS REPORT PERTAINS TO ONE OF TWO DEVICES USED IN THE SAME PATIENT AND PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN IMAGER II AND PERCUTANEOUS ACCESS NEEDLE WERE USED DURING A PERCUTANEOUS NEPHROLITHOTOMY (PCNL) PROCEDURE PERFORMED IN (B)(6) 2016. THE PATIENT EXPERIENCED SEPSIS. IN THE PHYSICIAN'S ASSESSMENT THE EVENT WAS PROBABLY RELATED TO THE IMAGER II AND PERCUTANEOUS ACCESS NEEDLE BUT THE RELATIONSHIP TO THE PROCEDURE WAS NOT REPORTED. ADDITIONAL INFORMATION RECEIVED ON APRIL 3, 2023: IT WAS REPORTED THAT THE PATIENT WAS GIVEN ANTIBIOTICS FOR SEPSIS. IN THE PHYSICIAN'S ASSESSMENT THE EVENT WAS PROBABLY RELATED TO THE IMAGER II AND PERCUTANEOUS ACCESS NEEDLE BUT WAS CAUSALLY RELATED TO THE PROCEDURE.
Patient problems: Sepsis
MAUDE report 16712495 ↗InjuryApr 11, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
NOTE: THIS REPORT PERTAINS TO ONE OF FOUR DEVICES USED IN THE SAME PATIENT AND PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN IMAGER II, NEPHROMAX BALLOON, PERCUTANEOUS ACCESS NEEDLE AND 8/10 DILATOR SHEATH SET WERE USED DURING A PERCUTANEOUS NEPHROLITHOTOMY (PCNL) PROCEDURE PERFORMED IN (B)(6) 2016. THE PATIENT EXPERIENCED GROSS HEMATURIA AND WAS ADMITTED FOR OBSERVATION. IN THE PHYSICIAN'S ASSESSMENT THE EVENT WAS NOT RELATED TO THE IMAGER II AND 8/10 DILATOR SHEATH SET BUT WAS CAUSALLY RELATED TO THE PROCEDURE. IN THE PHYSICIAN'S ASSESSMENT THE EVENT WAS PROBABLY RELATED TO THE NEPHROMAX BALLOON AND PERCUTANEOUS ACCESS NEEDLE BUT WAS CAUSALLY RELATED TO THE PROCEDURE.
Patient problems: Hematuria
MAUDE report 16712493 ↗InjuryApr 10, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
NOTE: THIS REPORT PERTAINS TO ONE OF FOUR DEVICES USED IN THE SAME PATIENT AND PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN IMAGER II, NEPHROMAX BALLOON, 8/10 DILATOR SHEATH SET AND PERCUTANEOUS ACCESS NEEDLE WERE USED DURING A PERCUTANEOUS NEPHROLITHOTOMY (PCNL) PROCEDURE PERFORMED IN (B)(6)2016. THE PATIENT EXPERIENCED ABDOMINAL PAIN AND WAS GIVEN INTRAVENOUS (IV) PAIN CONTROL. IN THE PHYSICIAN'S ASSESSMENT THE EVENT WAS POSSIBLY RELATED TO THE IMAGER II AND 8/10 DILATOR SHEATH SET BUT WAS CAUSALLY RELATED TO THE PROCEDURE. IN THE PHYSICIAN'S ASSESSMENT THE EVENT WAS PROBABLY RELATED TO THE NEPHROMAX BALLOON, PERCUTANEOUS ACCESS NEEDLE BUT WAS CAUSALLY RELATED TO THE PROCEDURE.
Patient problems: Abdominal Pain
MAUDE report 16710026 ↗
Other Boston Scientific Corporation products
- INGEVITY MRI7 models · 16,601 reports
- INGEVITY+3 models · 16,054 reports
- EMBLEM S-ICD4 models · 13,295 reports · 1 recall
- WATCHMAN25 models · 8,024 reports · 6 recalls
- AMS 800 Artificial Urinary Sphincter31 models · 7,515 reports · 2 recalls
- ENDOTAK RELIANCE SG9 models · 6,540 reports · 2 recalls
- RELIANCE 4-FRONT11 models · 5,739 reports
- FINELINE II EZ Sterox6 models · 5,633 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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