TRANSFORM M003SRC04100Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07613327004441), received between Jan 6, 2021 and Jan 6, 2021 — 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.

• MalfunctionJan 6, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT DURING THE PROCEDURE, THE SUBJECT BALLOON RUPTURED DURING USE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT CLINICAL CONSEQUENCE TO THE PATIENT. ADDITIONAL INFORMATION WAS RECEIVED THAT THE SUBJECT BALLOON CATHETER HAD BURST DURING PREPARATION OUTSIDE THE PATIENT. NO CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11122165 ↗
• MalfunctionJan 6, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT DURING THE PROCEDURE, THE SUBJECT BALLOON RUPTURED DURING USE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT CLINICAL CONSEQUENCE TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11122127 ↗

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-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-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,
• 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-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-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,