TRANSFORM M003SSC03050Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 07613327004717), received between Sep 18, 2020 and Oct 20, 2021 — classified as 1 injury, 2 malfunctions.

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

• InjuryOct 20, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A CLINICAL TRIAL, A FLOW DIVERTER WAS USED FOR TREATMENT. THE SUBJECT BALLOON WAS ALSO USED FOR IN STENT BALLOON ANGIOPLASTY IN A SMALL AREA OF NON-APPOSITION OF THE PROXIMAL END OF THE FLOW DIVERTER. EXCELLENT APPOSITION WAS ACHIEVED AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. POST PROCEDURE, THE PATIENT HAD A STROKE THAT PRESENTED AS RIGHT HEMIPARESIS. IMAGING DONE SHOWED DEVELOPMENT OF AN ILL DEFINED ACUTE TO EARLY SUB ACUTE INFARCT CENTERED ALONG THE POSTERIOR LIMB LEFT INTERNAL CAPSULE. PATIENT WAS THEN STARTED ON INTEGRILLIN INFUSION, TAKEN TO ICU AND PHENYLEPHRINE WAS THEN INITIATED. PATIENT WAS IN ICU FOR APPROXIMATELY 5 DAYS. IN THE PHYSICIAN'S OPINION, THE EVENT HAD A CAUSAL RELATIONSHIP TO DUAL ANTIPLATELET THERAPY, SUBJECT DEVICE, OTHER STRYKER DEVICE AND UNDERLYING CONDITION OR DISEASE. EVENT WAS REPORTED AS RECOVERING/RESOLVING. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: Paresis; Stroke/CVA

  MAUDE report 12669761 ↗
• MalfunctionSep 18, 2020Deflation Problem; Deflation Problem

  IT WAS REPORTED THAT THE BALLOON (SUBJECT DEVICE) WOULD NOT DEFLATE INSIDE THE PATIENT'S ANATOMY DURING THE PROCEDURE. 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 10556784 ↗
• MalfunctionSep 18, 2020Deflation Problem; Deflation Problem

  IT WAS REPORTED THAT THE BALLOON (SUBJECT DEVICE) WOULD NOT DEFLATE INSIDE THE PATIENT'S ANATOMY DURING THE PROCEDURE. 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 10556783 ↗

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-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-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-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-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-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,