TRANSFORM M003SSC07100Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 07613327004519), received between Sep 30, 2019 and Mar 24, 2022 — classified as 1 injury, 3 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (3 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 24, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT DURING PROCEDURE THE BALLOON (SUBJECT DEVICE) RUPTURED WHEN INSERTED INSIDE PIPELINE STENT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT A BALLOON. NO CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13884907 ↗
• InjuryNov 25, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT DURING A PROCEDURE THE OPERATOR ATTEMPTED TO DELIVER THE FLOW DIVERTER STENT TO THE TARGET LESION USING THE SUBJECT BALLOON. THE SUBJECT BALLOON WAS NOT PREPARED AND TESTED ACCORDING TO THE DIRECTIONS FOR USE BEFORE USING IT IN THE PATIENT. AFTER THE SUBJECT BALLOON REACHED THE TARGET LESION IT WAS INFLATED USING 100% CONTRAST MEDIA. DURING INFLATION EVEN BEFORE THE SUBJECT BALLOON COULD REACH THE OPTIMAL AMOUNT OF INFLATION, IT BURST INSIDE THE PATIENT'S VASCULAR ANATOMY. THE SUBJECT BALLOON WAS WITHDRAWN FROM THE PATIENT VASCULAR ANATOMY. A NEUROLOGICAL TEST WAS CONDUCTED ON THE PATIENT, APPROXIMATELY THREE HOURS AFTER THE SURGERY (AFTER THE PATIENT WOKE-UP FROM ANESTHESIA). IT WAS ASSESSED THAT THE PATIENT SUFFERED SCOTOMA (BLURRED VISION- AND PATCHINESS IN EYE). ACCORDING TO THE PHYSICIAN THE SUBJECT BALLOON WAS DEFECTIVE AND THIS WAS THE CAUSE OF THE RUPTURE. THE SUBJECT BALLOON WAS REPLACED WITH ANOTHER DEVICE AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: Blurred Vision

  MAUDE report 12873437 ↗
• MalfunctionOct 11, 2021Deflation Problem; Deflation Problem

  IT WAS REPORTED THAT DURING THE PROCEDURE, THE SUBJECT OCCLUSION BALLOON WAS UNABLE TO DEFLATE INSIDE THE PATIENT. 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 12610886 ↗
• MalfunctionSep 30, 2019Material Rupture; Material Rupture

  IT WAS REPORTED THAT WHILE TRYING TO INFLATE THE BALLOON CATHETER(SUBJECT DEVICE) , IT GOT RUPTURED INSIDE LEFT ICA (INTERNAL CAROTID ARTERY) DURING THE PROCEDURE. THERE WERE NO REPORTED CLINICAL CONSEQUENCES TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9135612 ↗

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-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-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-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,
• 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-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-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