TRANSFORM M003SRC05150Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 07613327004472), received between Nov 7, 2018 and Apr 3, 2024 — classified as 2 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Deflation Problem” (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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 3, 2024Material Puncture/Hole; Material Puncture/Hole

  THE BALLOON (SUBJECT DEVICE) WAS RETURNED FOR ANALYSIS AND IT WAS DISCOVERED THAT THERE WAS A TEAR/HOLE/PERFORATION NOTED ON THE BALLOON (SUBJECT DEVICE). 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 19035917 ↗
• MalfunctionJun 19, 2023Deflation Problem; Deflation Problem

  IT WAS REPORTED THAT DURING THE PROCEDURE, THE BALLOON (SUBJECT DEVICE) WAS INFLATED. WHEN THE BALLOON WAS ATTEMPTED TO DEFLATE IT WAS UNABLE TO DEFLATE. THE PHYSICIAN REPLACED IT WITH A NEW DEVICE AND CONTINUED THE PROCEDURE WITHOUT CLINICAL CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17154423 ↗
• InjuryMay 15, 2023Fracture; Fracture

  IT WAS REPORTED THAT DURING THE ADDITIONAL EMBOLIZATION PROCEDURE OF A 18 MONTHS PREVIOUSLY TREATED AREA, THE SHAFT OF THE SUBJECT BALLOON CATHETER WAS KINKED AND IT WAS PERFORATED BY A GUIDEWIRE. THE SHAFT OF THE SUBJECT BALLOON CATHETER WAS FRACTURED DURING RETRACTION. ATTEMPTS WERE MADE TO RETRIEVE THE BROKEN FRAGMENT OF THE SUBJECT BALLOON CATHETER USING THE SNARE DEVICE BUT IT WAS DIFFICULT TO BE REMOVED. THE BROKEN FRAGMENT OF THE SUBJECT BALLOON CATHETER WAS LEFT IN THE COMMON HEPATIC ARTERY. IN DOCTOR'S OPINION THERE WAS NO RISK OF COMPLICATIONS AND WOULD NOT IMPACT THE PATIENT. HE BELIEVES THAT THE SUBJECT BALLOON CATHETER SHAFT MAY HAVE BEEN OVERLOADED DUE TO THE MEANDERING ARTERY WITH HIGH DEGREE OF ARTERIOSCLEROSIS. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THE PATIENT'S CONDITION IS STABLE.

  Patient problems: Foreign Body In Patient

  MAUDE report 16930997 ↗
• MalfunctionMar 15, 2023Deflation Problem; Deflation Problem

  IT WAS REPORTED THAT DURING COIL EMBOLIZATION OF CELIAC ANEURYSM THE OCCLUSION BALLOON CATHETER (SUBJECT DEVICE) WAS ADVANCED TO THE TARGET SITE AFTER SETUP. WHEN INFLATION AND DEFLATION WERE PERFORMED, IT WAS NOTED THAT BOTH MOTIONS WERE SLOW. THE PHYSICIAN REPLACED IT WITH A NEW DEVICE AND CONTINUED THE PROCEDURE WITHOUT CLINICAL CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16546197 ↗
• MalfunctionFeb 20, 2023Leak/Splash; Material Rupture; Leak/Splash; Material Rupture

  IT WAS REPORTED THAT DURING EMBOLIZATION OF RENAL ARTERY ANEURYSM THE BALLOON (SUBJECT DEVICE) WAS ADVANCED INTO THE PATIENT¿S ANATOMY AND AN ATTEMPT TO INFLATE IT WAS MADE. HOWEVER, THE BALLOON (SUBJECT DEVICE) DID NOT INFLATE. WHEN RETRIEVED FROM THE PATIENT'S ANATOMY THE BALLOON (SUBJECT DEVICE) WAS FOUND TO BE RUPTURED AND CONTRAST AGENT WAS LEAKING OUT. THE PHYSICIAN REPLACED IT WITH A NEW DEVICE AND CONTINUED THE PROCEDURE WITHOUT CLINICAL CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16406384 ↗
• MalfunctionApr 12, 2019Break; Break

  IT WAS REPORTED THAT DURING PROCEDURE, THE SURGEON FELT RESISTANCE WITH THE SUBJECT BALLOON CATHETER AT THE TIME OF INSERTION OF THE MICROCATHETER. THEN THE BALLOON ¿BROKE¿. THE SUBJECT DEVICE WAS EXCHANGED WITH THE SAME NEW PRODUCT. THE SAME ISSUE OCCURRED WITH A SECOND BALLOON CATHETER. THE SECOND BALLOON CATHETER WAS EXCHANGED WITH THE SAME NEW PRODUCT. THE PROCEDURE CONTINUED AND WAS COMPLETED WITHOUT PROBLEM. THERE WERE NO CLINICAL CONSEQUENCES TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8511941 ↗
• InjuryNov 7, 2018Deflation Problem; Deflation Problem

  IT WAS REPORTED THAT DURING THE PROCEDURE, THE BALLOON CATHETER WAS UNABLE TO DEFLATE, DUE TO THROMBUS FORMATION INSIDE THE BALLOON LUMEN. THE PHYSICIAN WAS ABLE TO GET RID OF THE THROMBUS BY MANIPULATING THE GUIDEWIRE AND THE BALLOON WAS ABLE TO DEFLATE. THE BALLOON WAS CONTINUED TO BE USED; HOWEVER, SIMILAR ISSUE OCCURRED. THE BALLOON WAS REMOVED FROM THE PATIENT BODY. NO ADDITIONAL INFORMATION IS AVAILABLE CURRENTLY.

  Patient problems: Thrombus

  MAUDE report 8049080 ↗

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-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
• 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,