TRANSFORM M003SRC05100Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07613327004687), received between Jun 5, 2018 and Mar 24, 2022 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (2 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 2 most recent of 2 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 13884915 ↗
• MalfunctionJun 5, 2018Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE SUBJECT DEVICE BALLOON WAS RUPTURED DURING THE PROCEDURE. THERE WAS NO CLINICAL CONSEQUENCE TO THE PATIENT AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7571824 ↗

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-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-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-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,
• 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-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