TRANSFORMRecalls & reported problems across all models
Stryker Corporation · 13 models in the FDA device registry
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 55
- Deaths reported
- 3
- Injuries reported
- 6
- Recalls
- 0
We found 13 models of TRANSFORM by Stryker Corporation in the FDA's device registry (GUDID). Together they are named in 55 adverse event reports in the FDA's MAUDE database, received between Dec 2, 2016 and Feb 17, 2026 — classified as 3 deaths, 6 injuries, 46 malfunctions.
The most frequently reported specific device problem is “Material Rupture” (18 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 TRANSFORM problems
Device problems
- Material Rupture18
- Deflation Problem11
- Fluid/Blood Leak8
- Material Puncture/Hole8
- Leak/Splash5
- Adverse Event Without Identified Device or Use Problem3
- Fracture3
- Break1
Patient problems
- No Clinical Signs, Symptoms or Conditions32
- No Consequences Or Impact To Patient13
- Perforation of Vessels3
- No Patient Involvement2
- Aneurysm1
- Blurred Vision1
- Death1
- Foreign Body In Patient1
TRANSFORM models
13 models, most reported first. Each model has its own page with its reports, recalls and device details.
- TRANSFORM M003SSC07070Catheter, intravascular occluding, temporary17 reports
- TRANSFORM M003SRC05150Catheter, intravascular occluding, temporary7 reports
- TRANSFORM M003SSC04070Catheter, intravascular occluding, temporary2 deaths6 reports
- TRANSFORM M003SRC03100Catheter, intravascular occluding, temporary5 reports
- TRANSFORM M003SSC07100Catheter, intravascular occluding, temporary4 reports
- TRANSFORM M003SSC04100Catheter, intravascular occluding, temporary3 reports
- TRANSFORM M003SSC03050Catheter, intravascular occluding, temporary3 reports
- TRANSFORM M003SRC04100Catheter, intravascular occluding, temporary2 reports
- TRANSFORM M003SRC04200Catheter, intravascular occluding, temporary1 death2 reports
- TRANSFORM M003SSC07150Catheter, intravascular occluding, temporary2 reports
- TRANSFORM M003SRC05100Catheter, intravascular occluding, temporary2 reports
- TRANSFORM M003SRC03150Catheter, intravascular occluding, temporary1 report
- TRANSFORM M003SRC04150Catheter, intravascular occluding, temporary1 report
Recent TRANSFORM adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionFeb 17, 2026Fluid/Blood Leak; Material Rupture
IT WAS REPORTED THAT DURING THE PROCEDURE AFTER GUIDING THE SUBJECT BALLOON CATHETER TO LESION, THE PHYSICIAN ATTEMPTED TO INFLATE THE SUBJECT BALLOON. THE SUBJECT BALLOON WAS DIFFICULT TO INFLATE, ALTHOUGH THE CONTRAST AGENT IN THE SYRINGE HAD BEEN DEPLETED. WHEN THE SUBJECT BALLOON CATHETER WAS REMOVED FROM THE BODY, THE SUBJECT BALLOON WAS FOUND TO BE RUPTURED. THE SUBJECT DEVICE WAS REPLACED, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT DUE TO THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24361445 ↗MalfunctionNov 4, 2025Deflation Problem; Deflation Problem
IT WAS REPORTED THAT DURING THE FLOW DIVERTER PLACEMENT PROCEDURE FOR THE COIL COMPACTION OF THE INTERNAL CAROTID (IC) ANTERIOR WALL ANEURYSM PROCEDURE, THE OPERATOR INFLATED THE SUBJECT BALLOON INSIDE PATIENT'S ANATOMY. HOWEVER, WHEN ATTEMPTING TO DEFLATE THE SUBJECT BALLOON, THE CONTRAST AGENT DID NOT FLOW WELL, TAKING A CONSIDERABLE AMOUNT OF TIME. THE SUBJECT DEVICE WAS REPLACED, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT DUE TO THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23468304 ↗MalfunctionMay 15, 2025Material Puncture/Hole; Material Puncture/Hole
IT WAS REPORTED THAT DURING THE PROCEDURE, THE OPERATOR INSERTED THE SUBJECT BALLOON CATHETER INTO THE INTERMEDIATE CATHETER. WHEN INFLATION WAS PERFORMED IN THE TARGET VESSEL, THE SUBJECT BALLOON DID NOT EXPAND, SO IT WAS REMOVED. UPON INSPECTION, A HOLE WAS FOUND IN THE SUBJECT BALLOON. THE SUBJECT DEVICE WAS REPLACED, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT DUE TO THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22025277 ↗MalfunctionApr 28, 2025Material Puncture/Hole; Material Puncture/Hole
THE SUBJECT DEVICE WAS RETURNED FOR ANALYSIS AND THE DEVICE INVESTIGATION REVEALED THAT THE BALLOON HAD HOLE/PERFORATION DURING USE. THE SUBJECT DEVICE WAS REPLACED, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT DUE TO THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21922031 ↗MalfunctionFeb 6, 2025Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT DURING THE PROCEDURE, THE SUBJECT BALLOON DID NOT DILATE AND THERE WAS VISIBLE LEAKAGE OF CONTRAST MEDIUM. THE SUBJECT BALLOON WAS REPLACED, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT DUE TO THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21323685 ↗MalfunctionDec 26, 2024Material Puncture/Hole; Material Puncture/Hole
THE SUBJECT DEVICE WAS RETURNED FOR ANALYSIS AND THE DEVICE INVESTIGATION REVEALED THAT THE BALLOON HAS HOLE/PERFORATION DURING USE. THE SUBJECT DEVICE WAS REPLACED, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT DUE TO THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21021743 ↗MalfunctionNov 11, 2024Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT DURING THE PROCEDURE THE SUBJECT BALLOON WAS BROUGHT TO THE LESION AND DILATED. DURING THIS IT WAS DISCOVERED THAT THE SUBJECT BALLOON LEAKED THE CONTRAST AGENT. THE SUBJECT DEVICE WAS REPLACED, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT DUE TO THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20657529 ↗MalfunctionNov 5, 2024Fluid/Blood Leak; Fracture; Fluid/Blood Leak; Fracture
IT WAS REPORTED THAT DURING POST PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) PROCEDURE, THE OPERATOR DELIVERED THE SUBJECT BALLOON CATHETER AND ATTEMPTED TO INFLATE THE SUBJECT DEVICE. HOWEVER, THE SUBJECT BALLOON WAS FOUND TO BE LEAKING. UPON WITHDRAWAL, IT WAS DISCOVERED THAT THE SUBJECT BALLOON CATHETER WAS ALSO FRACTURED. THE SUBJECT DEVICE WAS REPLACED, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT DUE TO THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20612286 ↗MalfunctionNov 1, 2024Material Puncture/Hole; No Visual Prompts/Feedback; Material Puncture/Hole; No Visual Prompts/Feedback
IT WAS REPORTED THAT WHEN INFLATED THE SUBJECT BALLOON INSIDE THE BODY, IT COULD NOT BE SEEN UNDER FLUOROSCOPY, AND WHEN INFLATED OUTSIDE THE BODY, IT WAS CONFIRMED THAT THE SUBJECT BALLOON WAS TORN. THE SUBJECT DEVICE WAS REPLACED, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT DUE TO THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20591553 ↗MalfunctionMay 20, 2024Deflation Problem; Deflation Problem
IT WAS REPORTED THAT DURING THE PROCEDURE AFTER INFLATING THE SUBJECT BALLOON INSIDE THE BODY, DEFLATION WAS ATTEMPTED WITH A SYRINGE, BUT THE SUBJECT BALLOON FAILED TO DEFLATE. DESPITE THE REMOVAL OF THE GUIDEWIRE, THE SUBJECT BALLOON STILL DID NOT DEFLATE. THE DEVICE WAS REMOVED FROM THE BODY FOR A VISUAL INSPECTION, WHICH REVEALED A SEVERE KINK IN THE SUBJECT BALLOON'S LUMEN. THE SUBJECT BALLOON WAS REPLACED, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT DUE TO THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19354136 ↗MalfunctionApr 18, 2024Leak/Splash; Leak/Splash
IT WAS REPORTED THAT THE SUBJECT BALLOON WAS USED IN A DESIGN VALIDATION STUDY. DURING THIS TESTING THE SUBJECT BALLOON LEAKED DURING USE IN THE SIMULATION MODEL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19133973 ↗MalfunctionApr 18, 2024Material Rupture; Material Rupture
IT WAS REPORTED THAT THE SUBJECT BALLOON WAS USED IN A DESIGN VALIDATION STUDY. DURING THIS TESTING THE SUBJECT BALLOON BURST IMMEDIATELY AFTER FIRST INFLATION IN THE SIMULATION MODEL AND SO WAS REPLACED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19133972 ↗MalfunctionApr 3, 2024Material Puncture/Hole; Material Puncture/Hole
THE BALLOON (SUBJECT DEVICE) WAS RETURNED FOR ANALYSIS AND IT WAS DISCOVERED THAT THERE WAS A TEAR/HOLE/PERFORATION NOTED ON THE BALLOON (SUBJECT DEVICE). THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT DUE TO THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19035917 ↗MalfunctionNov 3, 2023Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT DURING THE PROCEDURE, THE OPERATOR PLACED A FLOW DIVERTER SYSTEM. NEXT, THE SUBJECT OCCLUSION BALLOON WAS GUIDED, AND AN ATTEMPT WAS MADE TO PERFORM THE POST-DILATION. HOWEVER, THE SUBJECT BALLOON COULD NOT BE INFLATED. WHEN IT WAS REMOVED FROM THE PATIENT'S ANATOMY AND INFLATED, THE SALINE SOLUTION WAS FOUND TO BE LEAKING. THE SUBJECT DEVICE WAS REPLACED, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT DUE TO THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18068443 ↗MalfunctionJun 19, 2023Deflation Problem; Deflation Problem
IT WAS REPORTED THAT DURING THE PROCEDURE, THE BALLOON (SUBJECT DEVICE) WAS INFLATED. WHEN THE BALLOON WAS ATTEMPTED TO DEFLATE IT WAS UNABLE TO DEFLATE. THE PHYSICIAN REPLACED IT WITH A NEW DEVICE AND CONTINUED THE PROCEDURE WITHOUT CLINICAL CONSEQUENCES TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17154423 ↗
Other Stryker Corporation products
- RemB7 models · 3,073 reports
- Prime Series21 models · 1,548 reports · 2 recalls
- TARGET114 models · 1,077 reports
- ProCuity17 models · 368 reports · 13 recalls
- Spetzler-Malis20 models · 7 reports · 19 recalls
- SYNCHRO 28 models · 313 reports · 9 recalls
- Neptune E-SEP19 models · 412 reports · 7 recalls
- StrykeFlow4 models · 552 reports · 4 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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