TRANSFORM M003SRC03100Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 07613327004410), received between Aug 8, 2018 and Feb 8, 2021 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 8, 2021Component Missing; Component Missing

  IT WAS REPORTED THAT DURING THE PROCEDURE, THE BALLOON (SUBJECT DEVICE) WAS INFLATED HOWEVER, THE RADIOPAQUE CONTRAST INSIDE THE INFLATED BALLOON WAS NOT VISIBLE ON SCREEN. THE INFLATION WAS CONFIRMED BY THE PHYSICIAN BY MOVEMENT OF THE INTRAOPERATIVE ADJACENT COILING ACTIVITY AND RADIOPAQUE CONTRAST WAS STILL NOT VISIBLE. NO CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11291306 ↗
• MalfunctionOct 19, 2018Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT DURING PREPARATION ON THE BACK TABLE, THE SUBJECT DEVICE BALLOON PAIRED WITH A FLOPPY WIRE AND DURING PREP TEST INFLATION WITH A WIRE, THERE WAS LEAKAGE AT THE DISTAL END. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT DUE TO THE REPORTED EVENT.

  Patient problems: No Patient Involvement

  MAUDE report 7987203 ↗
• MalfunctionOct 19, 2018Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT DURING PREPARATION ON THE BACK TABLE, THE SUBJECT DEVICE BALLOON PAIRED WITH A FLOPPY WIRE AND DURING PREP TEST INFLATION WITH A WIRE, THERE WAS LEAKAGE AT THE DISTAL END. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT DUE TO THE REPORTED EVENT.

  Patient problems: No Patient Involvement

  MAUDE report 7987200 ↗
• MalfunctionAug 31, 2018Deflation Problem; Deflation Problem

  IT WAS REPORTED THAT THE BALLOON CATHETER FAILED TO DEFLATE COMPLETELY DURING THE PROCEDURE. THERE WERE NO REPORTED CLINICAL CONSEQUENCES TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7838523 ↗
• MalfunctionAug 8, 2018Material Rupture; Material Rupture

  IT WAS REPORTED THAT DURING PROCEDURE, THE FIRST BALLOON CATHETER (SUBJECT DEVICE) WAS RUPTURED. THE FIRST BALLOON WAS REMOVED FROM THE PATIENT'S BODY AND REPLACE WITH A 2ND BALLOON CATHETER. DURING USE OF THE 2ND BALLOON CATHETER, EXTRAVASATION WAS OBSERVED. NO ADDITIONAL INFORMATION IS AVAILABLE CURRENTLY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7765553 ↗

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-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-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-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-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