TRANSFORM M003SSC04070Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 07613327004694), received between Dec 6, 2016 and Apr 28, 2025 — classified as 2 deaths, 1 injury, 3 malfunctions.

The most frequently reported specific device problem is “Fracture” (1 report).

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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• InjuryJun 13, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT DURING THE ANTERIOR CEREBRAL ARTERY PROCEDURE, THE BALLOON (SUBJECT DEVICE) RUPTURED INSIDE THE PATIENT'S ANATOMY. ALSO, THE PATIENT BLOOD VESSEL WAS RUPTURED. NO FURTHER INFORMATION AVAILABLE ABOUT THE PROCEDURE AND PATIENT CONDITION.

  Patient problems: Perforation of Vessels

  MAUDE report 14675022 ↗
• DeathJun 3, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING THE ANTERIOR CEREBRAL ANEURYSM (ACA) COIL EMBOLIZATION PROCEDURE WHILE PLACING THE EMBOLIZATION COIL INSIDE THE ANEURYSM THE PHYSICIAN NOTICED A THROMBUS FORMING CLOSE TO THE NECK OF THE ANEURYSM. THE PHYSICIAN STOPPED THE COILING AND REMOVED THE MICROCATHETER FROM THE PATIENT'S ANATOMY. ADMINISTERED PHARMACOLOGICAL AGENTS TO THE PATIENT TO ADDRESS THE THROMBUS, AFTER A FEW MINUTES, THE PHYSICIAN DID A CONTRAST RUN AND STILL SAW SLOW FLOW INTO THE ACA AND CONTRALATERAL A2. THE PHYSICIAN PLANNED TO STENT THE ARTERY SO ANOTHER MICROCATHETER AND GUIDE WIRE WAS PLACED INTO THE IPSILATERAL A2. AT THIS POINT, THERE WAS NO CONTRAST SEEN FLOWING INTO THE OTHER A2, THEN THE PHYSICIAN DECIDED TO PERFORM ASPIRATION. GUIDEWIRE AND MICROCATHETER WERE PLACED INTO THE VESSEL HAD THE THROMBUS/NO BLOOD FLOW. THE PHYSICIAN TOOK THE GUIDE WIRE DISTAL TO THE LOCATION OF THE THROMBUS AND USED THE ASPIRATION CATHETER TO TAKE THE THROMBUS OUT OF THE PATIENT'S ANATOMY. PRIOR TO THE ASPIRATION THE PHYSICIAN PERFORMED A CONTRAST RUN THROUGH THE ARTERY, EXTRAVASATION AND ARTERY PERFORATION COULD BE SEEN NEAR THE CONTRALATERAL A2. THE PHYSICIAN ADMINISTERS PROTAMINE TO THE PATIENT

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Perforation of Vessels

  MAUDE report 14586128 ↗
• MalfunctionDec 15, 2020Fracture; Fracture

  IT WAS REPORTED THAT DURING THE PROCEDURE WHEN THE BALLOON CATHETER (SUBJECT DEVICE) WAS ATTEMPTED TO INFLATE INSIDE THE BODY, THE BALLOON BROKE AND IT COULD NOT INFLATE. THE SUBJECT BALLOON CATHETER FRAGMENT WAS COMPLETELY REMOVED FROM THE PATIENT¿S ANATOMY WITHOUT A SNARE. 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 11009222 ↗
• MalfunctionApr 21, 2017Leak/Splash; Leak/Splash

  IT WAS REPORTING THAT DURING PROCEDURE THE BALLOON WAS LEAKING AROUND THE SEAL. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6513527 ↗
• DeathDec 6, 2016Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING COIL EMBOLIZATION OF A LEFT INTERNAL CAROTID ARTERY (ICA) UNRUPTURED ANEURYSM, AFTER PLACING A FIRST COIL UNEVENTFULLY IN THE ANEURYSM, ¿THE PHYSICIAN WAS NOT SURE IF THE COIL WAS HERNIATING INTO THE VESSEL¿. MEDICAL INTERVENTION WITH AN OCCLUSION BALLOON CATHETER (SUBJECT DEVICE) WAS PERFORMED IN ORDER TO PUSH BACK THE HERNIATED COIL PART INTO THE ANEURYSM. THE PHYSICIAN INFLATED THE BALLOON FOR 30 SECONDS AND THE DISTAL ICA OR THE ANEURYSM RUPTURED LEADING TO HEMORRHAGE. BLOOD FLOW DISTAL TO THE RUPTURED WAS BLOCKED. THE PATIENT EXPIRED DUE TO BLEEDING. THE PHYSICIAN STATED THAT THE VESSEL RUPTURE WAS RELATED TO THE BALLOON INFLATION AND THE PATIENT DEATH WAS RELATED TO THE BALLOON INFLATION AND THE PATIENT¿S VASCULATURE.

  Patient problems: Aneurysm; Death; Hemorrhage, Cerebral; Perforation of Vessels; Rupture

  MAUDE report 6149801 ↗

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-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-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-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-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-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-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-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-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,