TRANSFORM M003SSC07070Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 07613327004700), received between Dec 2, 2016 and Feb 17, 2026 — classified as 1 injury, 16 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (6 reports).

8 other recalls cover devices cleared under the same FDA submission (K122576); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 17 most recent of 17 reports, 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 ↗
• 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 ↗
• 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 ↗
• MalfunctionFeb 27, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT DURING A NEUROVASCULAR PROCEDURE, THE SUBJECT BALLOON DID NOT INFLATE WHEN IT WAS USED TO ADJUST A FLOW DIVERTER AGAINST THE WALLS OF THE VESSEL. UPON REMOVAL FROM THE PATIENT'S ANATOMY FOR A VISUAL INSPECTION, THE BALLOON WAS FOUND BURST/RUPTURED. THE SUBJECT BALLOON WAS REPLACED AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO CLINICAL CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16449310 ↗
• MalfunctionJun 28, 2022Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE GUIDEWIRE WAS SET ON THE BALLOON (SUBJECT DEVICE) AND PASSED THROUGH THE LESION. THE BALLOON (SUBJECT DEVICE) WAS INFLATED WITH 80% DILUTED CONTRAST, BUT IT GRADUALLY LEAKED AND SHRANK FROM THE TIP. THE CONTRAST WAS INCREASED TO 100% AND INFLATION WAS PERFORMED AGAIN, BUT THE SAME PROBLEM STILL OCCURRED. THE PROCEDURE ITSELF WAS COMPLETED USING THE SAME GUIDE WIRE AND THE BALLOON (SUBJECT DEVICE) AS THEY WERE. NO CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14842409 ↗
• MalfunctionMar 17, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT DURING THE PROCEDURE, THE BALLOON (SUBJECT DEVICE) RUPTURED. THE PATIENTS MEDICAL CONDITION WAS GOOD AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WERE NO CLINICAL CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11508504 ↗
• MalfunctionMay 29, 2020Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT DURING THE PROCEDURE THE BALLOON (SUBJECT DEVICE) CONTRAST LEAKED. THE BALLOON WAS REPLACED THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WERE NO CLINICAL CONSEQUENCES TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10103302 ↗
• MalfunctionMay 20, 2019Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT THERE WAS A HOLE IN THE BALLOON (SUBJECT DEVICE) . THERE WERE NO CLINICAL CONSEQUENCES TO THE PATIENT DUE TO THE REPORTED EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8625123 ↗
• MalfunctionNov 29, 2018Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE BALLOON CATHETER FAILED TO INFLATE, WAS REMOVED FROM THE PATIENT'S BODY AND WAS NOTED TO BE LEAKING. THERE WERE NO REPORTED CLINICAL CONSEQUENCES TO THE PATIENT. THE PHYSICIAN REPLACED IT WITH A NEW BALLOON CATHETER AND COMPLETED THE PROCEDURE WITHOUT CLINICAL CONSEQUENCES TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8118452 ↗
• InjuryDec 2, 2016Deflation Problem; Material Rupture; Material Separation; Deflation Problem; Material Rupture; Material Separation

  DURING PLACEMENT OF A COMPETITOR COIL IN THE LEFT RENAL ARTERY ANEURYSM USING AN OCCLUSION BALLOON CATHETER, THE COIL PREMATURELY DETACHED. THE COIL WAS ATTEMPTED TO BE REMOVED WITH A SNARE DEVICE, AND 1.5 HOURS WERE SPENT IN RETRIEVAL ATTEMPTS. THE OCCLUSION BALLOON CATHETER WAS KEPT INFLATED DURING THIS TIME. IT WAS REPORTED THAT DURING RETRIEVAL OF THE COIL, A DISSECTION WAS CAUSED BY THE GUIDE SHEATH. THE PHYSICIAN TRIED TO DEFLATE THE OCCLUSION BALLOON CATHETER IN ORDER TO DEPLOY THE STENT IN THE DISSECTED AREA, HOWEVER, THE BALLOON WOULD NOT DEFLATE. THE PHYSICIAN REMOVED THE GUIDEWIRE TO ACHIEVE DEFLATION BUT IT DID NOT WORK. DEFLATION BY USING THE SYRINGE AND INSERTING AND RETRACTING THE GUIDEWIRE FAILED. THE GUIDEWIRE WAS INSERTED/RETRACTED THROUGH THE LUMEN OF THE OCCLUSION BALLOON CATHETER IN ORDER TO MAINTAIN PATENCY. THEY PHYSICIAN ATTEMPTED TO BURST THE BALLOON BY PERFORMING OVER INFLATION; HOWEVER, THE SHAFT NEAR THE BALLOON BURST INSTEAD. THE PHYSICIAN THEN NAVIGATED THE GUIDE SHEATH TO THE PROXIMAL SECTION OF THE BALLOON AND ATTEMPTED TO PULL IT OUT BY FORCE, BUT THE OCCLUSION BALLOON SEPARATED AT THE BALLOON BURST SECTION. THE BALLOON SECTION REMAINED INSIDE THE P

  Patient problems: No Information

  MAUDE report 6143449 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K122576. One submission often covers many models, so check the product and lot details in each record.

• Z-0507-2014 · Nov 4, 2013 · Terminated
  Stryker brand COMPLIANT 4MM X 20MM, Catalog Number: M003SRC04200; Product is manufactured by Stryker Neurovascular, Cork, Ireland and distributed by Stryker Neurovascular, Fremont,
• Z-0511-2014 · Nov 4, 2013 · Terminated
  Stryker brand SUPER COMPLIANT 4MM X 7MM, Catalog Number: M003SSC04070; Product is manufactured by Stryker Neurovascular, Cork, Ireland and distributed by Stryker Neurovascular, Fr
• Z-0510-2014 · Nov 4, 2013 · Terminated
  Stryker brand COMPLIANT 5MM X 30MM, Catalog Number: M003SRC05300; Product is manufactured by Stryker Neurovascular, Cork, Ireland and distributed by Stryker Neurovascular, Fremont
• Z-0512-2014 · Nov 4, 2013 · Terminated
  Stryker brand SUPER COMPLIANT 7MM X 15MM, Catalog Number: M003SSC07150; Product is manufactured by Stryker Neurovascular, Cork, Ireland and distributed by Stryker Neurovascular, F
• Z-0508-2014 · Nov 4, 2013 · Terminated
  Stryker brand COMPLIANT 4MM X 30MM, Catalog Number: M003SRC04300; Product is manufactured by Stryker Neurovascular, Cork, Ireland and distributed by Stryker Neurovascular, Fremont,
• Z-0509-2014 · Nov 4, 2013 · Terminated
  Stryker brand COMPLIANT 5MM X 15MM, Catalog Number: M003SRC05150; Product is manufactured by Stryker Neurovascular, Cork, Ireland and distributed by Stryker Neurovascular, Fremont
• Z-0506-2014 · Nov 4, 2013 · Terminated
  Stryker brand COMPLIANT 4MM X 15MM, Catalog Number: M003SRC04150; Product is manufactured by Stryker Neurovascular, Cork, Ireland and distributed by Excelsior SL-10/Excelsior 1018
• Z-0505-2014 · Nov 4, 2013 · Terminated
  Stryker brand COMPLIANT 4MM X 10MM, Catalog Number: M003SRC04100; Product is manufactured by Stryker Neurovascular, Cork, Ireland and distributed by Stryker Neurovascular, Fremont,